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Last update: November 12, 2013.
1

September 9, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Vaccines & Related Biological Products Advisory Committee ... Page 2. Vaccines & Related Biological Products Advisory Committee ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

2

VACCINES AND RELATED BIOLOGICAL PRODUCTS ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... facilitate development, ensuring safety of biological products, advancing regulatory ... 15 16 17 18 19 20 21 22 biochemistry, molecular biology, cell ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

3

Summary Minutes Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Summary Minutes Vaccines and Related Biological Products Advisory Committee September 19, 2012 FDA White Oak Campus, Bldg. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

4

Vaccines and Related Biological Products Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... [Docket No. FDA-2011-N-0002] Vaccines and Related Biological Products Advisory Committee; Amendment of Notice AGENCY ... More results from www.fda.gov/downloads/advisorycommittees/calendar

5

July 23, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Vaccines & Related Biological Products Advisory Committee ... Page 2. Vaccines & Related Biological Products Advisory Committee July 23, 2009 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

6

May 7, 2010: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... Evaluation and Research Vaccines and Related Biological Products Advisory Committee Meeting May 7, 2010 Hilton Hotel, Gaithersburg, MD ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

7

April 6-7, 2011: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Summary Minutes. Food and Drug ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

8

February 27, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... February 27, 2013: Vaccines and Related Biological Products Advisory Committee Meeting Announcement. Center. Date. Time. Location. CBER. ... More results from www.fda.gov/advisorycommittees/calendar

9

April 6-7, 2011: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Announcement. Center. Date. Time. Location. CBER. ... More results from www.fda.gov/advisorycommittees/calendar

10

February 25, 2011: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... Presentation: Information for the Vaccines and Related Biological Products Advisory Committee (Swine and Avian Influenza) (PPTX - 964KB ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

11

Vaccines and Related Biological Products Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Biologicals) - 1 -- Page 2. Table of Contents Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (Q-Pan H5N1) 1.0 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

12

Vaccines and Related Biological Products Advisory: Cervarix ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Cervarix ® : Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant. Applicant: GlaxoSmithKline Biologicals (GSK). ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

13

September 9, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionFood and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

14

Biologic Vaccines  

PubMed Central

The threat of new disease pandemics has spurred the development of biologic vaccines, which promise tremendous improvements in global and local health. Several lend themselves to the prevention or treatment of chronic diseases. But the uncertainties of whom to vaccinate raise the question of whether the health care system can make these promising products viable.

ADAMS, KATHERINE T.

2009-01-01

15

76 FR 13646 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2011-N-0002] Vaccines and Related Biological Products Advisory...closed to the public. Name of Committee: Vaccines and Related Biological Products Advisory...and Allergenic Products, Office of Vaccines Research and Review, Center for...

2011-03-14

16

February 22, 2010: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Page 3. Vaccines & Related Biological Products Advisory Committee ... Nancy Cox, Ph.D. Centers for Disease Control and Prevention Atlanta, GA ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

17

February 27, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... The transcript may be viewed on the World Wide Web at the 2013 Meeting Materials, Vaccines and Related Biological Products Advisory ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

18

September 9, 2009: Vaccines & Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... in the 3 months immediately after vaccination. ... for licensure of HPV vaccines and determined ... AIS or worse associated with vaccine HPV types could ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

19

Vaccines and Related Biological Products Advisory ...  

Center for Biologics Evaluation and Research (CBER)

... closely with manufacturers of the two licensed rotavirus vaccines, has consulted with experts inside and outside of the federal government, and has ... More results from www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts

20

The Vaccines and Related Biological Products Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... pathways for pandemic influenza vaccines. To get our taste buds whetted, we'll call on Dr. Marion Gruber, the acting director ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

21

Vaccines and Related Biological Products Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... At time of analysis, 60 cases identified in ATP cohort. ... 22. CIN2+ Related to Non-Vaccine HPV Type(s) (ATP Cohort for Efficacy). 37.4%. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

22

Vaccines and Related Biological Products Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... & Allergenic Products; Laboratory of Hepatitis Viruses, and Laboratory of Vector Borne Virus Diseases, Division of Viral ... More results from www.fda.gov/downloads/advisorycommittees/calendar

23

78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...open to the public. Name of Committee: Vaccines and Related Biological Products Advisory...selection of strains to be included in the influenza virus vaccine for the 2013- 2014 influenza season. FDA intends to make background...

2013-01-25

24

75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...open to the public. Name of Committee: Vaccines and Related Biological Products Advisory...selection of strains to be included in the influenza virus vaccine for the 2010 - 2011 influenza season. FDA intends to make background...

2010-01-19

25

76 FR 3639 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...open to the public. Name of Committee: Vaccines and Related Biological Products Advisory...selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season. The committee will also hear...

2011-01-20

26

September 9, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... and Related Biological Products Advisory Committee to ... topics that included product proposed indication ... biological plausibility, the natural history of ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

27

Building and Measuring Confidence: The Biological and Toxin Weapons Convention and Vaccine Production in Russia.  

National Technical Information Service (NTIS)

Vaccine production involves expertise, equipment and pathogens that in some instances are highly similar to those for production of biological weapons (BW) agents. The aim of this study was to analyze issues related to biological weapons and the dual-use ...

K. S. Westerdahl

2001-01-01

28

July 23, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... logistics of communication of a vaccination regimen. ... adjuvanted vaccines may support immunization in this ... for example, an H5N1 vaccine to which ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

29

May 8, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... Biological Products Advisory Committee 133rd Meeting via Teleconference Rockwall II, Conference Room 1033 5515 Security Lane, Rockville, MD ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

30

2011 Meeting Materials, Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

... 2011 Meeting Materials, Vaccines and Related Biological Products Advisory Committee. -. November 16, 2011: Vaccines ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

31

April 6-7, 2011: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... Presentation: Epidemiology of Meningococcal Disease in Infants and Young Children and Vaccine Effectiveness of the Adolescent Program (PPTX ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

32

April 6-7, 2011: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... 20201. Thomas Clark, MD, MPH +++ Prevention Branch, Influenza Division Meningitis and Vaccine Preventable Diseases Br. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

33

February 27, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... MS, FDA. Topic 1: Strain Selection for the Influenza Virus Vaccine for the 2013-2014 Influenza Season. 8:45, Introduction, ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

34

July 23, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... Please discuss whether FDA's approach to license ... Please comment on approaches to assessing vaccine ... potential need for diagnostic methods to ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

35

February 27, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... busy year for us in the influenza vaccine world, besides ... issues related to it to this committee. ... density map of the United States, and you can see we ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

36

September 9, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... will discuss and make recommendations on the safety and effectiveness in females of a vaccine against Human Papillomavirus manufactured by ... More results from www.fda.gov/advisorycommittees/calendar

37

July 23, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... 2.3 Manufacturing Considerations: As of mid-June, 2009 ... influenza A (H1N1) vaccine manufacture is uncertain ... events (SAEs) and new onset chronic ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

38

February 25, 2011: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... An additional update on Febrile Seizure Signal after the 2010-2011 Influenza Vaccine was provided by FDA prior to closure of the meeting. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

39

May 8, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... Center, Dept of Biochemistry & Molec. Biology, PO Box 26901 Oklahoma City, OK 73190. Edgar Marcuse, MD, MPH Expertise ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

40

February 27, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... of Biochemistry & Molecular Biology, BMSB-840 University of Oklahoma Health Sciences Center, Dept of Biochemistry & Molec. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

41

FDA Briefing Document. Vaccines and Related Biological Products Advisory Committee Meeting September 19, 2012: Cell Lines Derived from Human Tumors for Vaccine Manufacture.  

National Technical Information Service (NTIS)

This meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is being held to discuss the use of cell lines derived from human tumors as substrates for the production of preventive viral vaccines. Over the last decade, it has b...

2012-01-01

42

November 16, 2011: Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

... Vaccines and Related Biological Products Advisory Committee Meeting: Update on Surveillance for Guillain-Barré Syndrome After Vaccination with ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

43

2012 Meeting Materials, Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

... Committee. -. 2012 Meeting Materials, Vaccines and Related Biological Products Advisory Committee. -. November 14-15, 2012. On ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

44

November 13, 2013: Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

... November 13, 2013: Vaccines and Related Biological Products Advisory Committee Meeting Waivers for Conflicts of Interest. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

45

Biological Product Deviation Reporting - Blood Product Codes  

Center for Biologics Evaluation and Research (CBER)

... Vaccines, Blood & Biologics. ... Biological Product Deviation Reporting - Blood Product Codes. DB01 - Whole Blood DB05 ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/reportaproblem

46

Rabies vaccine. Developments employing molecular biology methods.  

PubMed

Rabies vaccines produced by means of molecular biology are described. Recombinant vaccines employing either viruses as vectors (vaccinia, adenovirus, poxvirus, baculovirus, plant viruses) or a plasmid vector carrying the rabies virus glycoprotein gene are discussed. Synthetic peptide technology directed to rabies vaccine production is also presented. PMID:10464768

Paolazzi, C C; Pérez, O; De Filippo, J

1999-04-01

47

Evaluation of growth based rapid microbiological methods for sterility testing of vaccines and other biological products.  

PubMed

Most biological products, including vaccines, administered by the parenteral route are required to be tested for sterility at the final container and also at various stages during manufacture. The sterility testing method described in the Code of Federal Regulations (21 CFR 610.12) and the United States Pharmacopoeia (USP, Chapter <71>) is based on the observation of turbidity in liquid culture media due to growth of potential contaminants. We evaluated rapid microbiological methods (RMM) based on detection of growth 1) by adenosine triphosphate (ATP) bioluminescence technology (Rapid Milliflex(®) Detection System [RMDS]), and 2) by CO(2) monitoring technologies (BacT/Alert and the BACTEC systems), as alternate sterility methods. Microorganisms representing Gram negative, Gram positive, aerobic, anaerobic, spore forming, slow growing bacteria, yeast, and fungi were prepared in aliquots of Fluid A or a biological matrix (including inactivated influenza vaccines) to contain approximately 0.1, 1, 10 and 100 colony forming units (CFU) in an inoculum of 10 ml. These preparations were inoculated to the specific media required for the various methods: 1) fluid thioglycollate medium (FTM) and tryptic soy broth (TSB) of the compendial sterility method (both membrane filtration and direct inoculation); 2) tryptic soy agar (TSA), Sabouraud dextrose agar (SDA) and Schaedler blood agar (SBA) of the RMDS; 3) iAST and iNST media of the BacT/Alert system and 4) Standard 10 Aerobic/F and Standard Anaerobic/F media of the BACTEC system. RMDS was significantly more sensitive in detecting various microorganisms at 0.1CFU than the compendial methods (p<0.05), whereas the compendial membrane filtration method was significantly more sensitive than the BACTEC and BacT/Alert methods (p<0.05). RMDS detected all microorganisms significantly faster than the compendial method (p<0.05). BacT/Alert and BACTEC methods detected most microorganisms significantly faster than the compendial method (p<0.05), but took almost the same time to detect the slow growing microorganism P. acnes, compared to the compendial method. RMDS using SBA detected all test microorganisms in the presence of a matrix containing preservative 0.01% thimerosal, whereas the BacT/Alert and BACTEC systems did not consistently detect all the test microorganisms in the presence of 0.01% thimerosal. RMDS was compatible with inactivated influenza vaccines and aluminum phosphate or aluminum hydroxide adjuvants at up to 8 mg/ml without any interference in bioluminescence. RMDS was shown to be acceptable as an alternate sterility method taking 5 days as compared to the 14 days required of the compendial method. Isolation of microorganisms from the RMDS was accomplished by re-incubation of membranes with fresh SBA medium and microbial identification was confirmed using the MicroSEQ Identification System. BacT/Alert and BACTEC systems may be applicable as alternate methods to the compendial direct inoculation sterility method for products that do not contain preservatives or anti-microbial agents. PMID:21871516

Parveen, Seema; Kaur, Simleen; David, Selwyn A Wilson; Kenney, James L; McCormick, William M; Gupta, Rajesh K

2011-08-24

48

November 16-17, 2010: Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

... November 16-17, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Transcripts. -. Meeting Transcripts. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

49

77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...selection of strains to be included in the influenza virus vaccine for the 2012 to 2013 influenza season. On February 29, 2012, the committee...discuss licensure pathways for pandemic influenza vaccines. FDA intends to make background...

2012-01-25

50

Vaccines, Blood & Biologics  

Center for Biologics Evaluation and Research (CBER)

... Vaccines for Use in Children and Adults, Tuberculin Testing. ... Labeling, Advertising, IND, PMA, BLA, NDA, 510(k). ... Food and Drug Administration. ... More results from www.fda.gov/biologicsbloodvaccines

51

Production of viral vaccines for veterinary use.  

PubMed

This review provides inside information on the production of vaccines for veterinary use. The vaccines against rinderpest as well as foot and mouth disease are considered milestones in the history of veterinary vaccine production. Modern vaccines are based on the scientific progress in virology, cell biology and immunology. While naturally occurring attenuated viruses or viruses obtained after passage in different animal species or cell culture were used as vaccine strains in the early vaccines, nowadays targeted mutagenesis can be applied to generate vaccine virus strains. In principle, the antigen production process is the same for live and inactivated vaccines. The vaccine virus is usually grown in cell culture, either in roller bottles or bioreactors. Most live vaccines are freeze-dried in order to enable storage in the refridgerator for a longer period. To this end, a so-called stabilizer is added to the culture medium. The inactivation of the vaccine virus for the production of killed vaccines is done by physical or chemical treatments that lead to denaturation of the proteins or damage of the nucleic acids. The inactivated antigen may be further purified and mixed with an adjuvant. The quality standards for vaccines are layed down in international regulations and laws. Numerous tests are performed during the different production steps and on the final product in order to warrant the quality of each batch. PMID:22515027

van Gelder, Pieter; Makoschey, Birgit

52

77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15, 2012, the committee will meet in open...

2012-10-17

53

Plant Production of Veterinary Vaccines and Therapeutics  

Microsoft Academic Search

Plant-derived biologicals for use in animal health are becoming an increasingly important target for research into alternative,\\u000a improved methods for disease control. Although there are no commercial products on the market yet, the development and testing\\u000a of oral, plant-based vaccines is now beyond the proof-of-principle stage. Vaccines, such as those developed for porcine transmissible\\u000a gastroenteritis virus, have the potential to

R. W. Hammond; L. G. Nemchinov

54

Biological Warfare Defense Vaccine Research & Development Programs  

NSDL National Science Digital Library

This 190-page .pdf document, dated July 2001 but released online September 7, 2001 by the US Department of Defense (DoD), gives the latest status of biological warfare defense vaccine development. The DoD assembled a panel of experts in the scientific, regulatory, and industrial aspects of vaccine production and in federal procurement to review the topic. They concluded that the scope and complexity of the DoD biological warfare defense vaccine requirements were too great for either the DoD or the pharmaceutical industry to accomplish alone. The first part of this online report is an executive summary from the DoD, followed by the Floyd D. Spence National Defense Authorization Act For Fiscal Year 2001, and finally the independent panel's full report, Department of Defense Acquisition of Vaccine Production, of December 2000. Sections of the dense, 167-page report include financial and personnel resource requirements, policies, findings, and recommendations.

2001-01-01

55

Biosimilar Biological Products  

Center for Drug Evaluation (CDER)

Text VersionPage 1. Biosimilar Biological Products Rachel E. Sherman, MD, MPH ... Antibody Biological ProductsBiological products may be manufactured ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

56

Systems biology of vaccination for seasonal influenza in humans  

Microsoft Academic Search

Here we have used a systems biology approach to study innate and adaptive responses to vaccination against influenza in humans during three consecutive influenza seasons. We studied healthy adults vaccinated with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV). TIV induced higher antibody titers and more plasmablasts than LAIV did. In subjects vaccinated with TIV, early molecular

Helder I Nakaya; Jens Wrammert; Eva K Lee; Luigi Racioppi; Stephanie Marie-Kunze; W Nicholas Haining; Anthony R Means; Sudhir P Kasturi; Nooruddin Khan; Gui-Mei Li; Megan McCausland; Vibhu Kanchan; Kenneth E Kokko; Shuzhao Li; Rivka Elbein; Aneesh K Mehta; Alan Aderem; Kanta Subbarao; Rafi Ahmed; Bali Pulendran

2011-01-01

57

Vaccine Production Process.  

National Technical Information Service (NTIS)

The patent application discloses a viral vaccine effective against foot-and-mouth disease which is produced without the use of serum or nonchemically defined serium substitutes. A viable culture of baby hamster kidney cells in a heat-stable, glutamine-fre...

L. D. Tomei

1975-01-01

58

Vaccine production in Neurospora crassa  

Microsoft Academic Search

We have chosen to use the filamentous fungus Neurospora crassa to produce subunit vaccines. Here we describe the production and purification of Influenza hemagglutinin and neuraminidase antigens in N. crassa. The N. crassa system used by Neugenesis offers many advantages over other systems for production of recombinant protein. In contrast to mammalian cell culture, N. crassa can be grown in

Silke Allgaier; Rebecca D. Taylor; Yuliya Brudnaya; David J. Jacobson; Edward Cambareri; W. Dorsey Stuart

2009-01-01

59

Biologics Procedures (SOPPs)  

Center for Biologics Evaluation and Research (CBER)

... Products; Vaccines, Blood & Biologics; Animal & Veterinary; Cosmetics; Tobacco Products. Vaccines, Blood & Biologics. Print; ... More results from www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/proceduressopps

60

Safety & Availability (Biologics)  

Center for Biologics Evaluation and Research (CBER)

... Products; Vaccines, Blood & Biologics; Animal & Veterinary; Cosmetics; Tobacco Products. Vaccines, Blood & Biologics. Print; ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability

61

Therapeutic Biological Products Approvals  

Center for Drug Evaluation (CDER)

... Therapeutic Biological Products Approvals. We are no longer updating this page. The last update of this page occurred on December 12, 2003. ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved

62

Development of pandemic influenza vaccine production capacity in Viet Nam.  

PubMed

The Institute of Vaccines and Medical Biologicals (IVAC), a state-owned vaccine manufacturer, initiated research into avian influenza vaccines in the early 1990 s in response to the threat of a highly pathogenic avian influenza pandemic. Successful results from laboratory studies on A(H5N1) influenza virus attracted seed funds and led to participation in the WHO technology transfer project to enhance influenza vaccine production in developing countries. IVAC's goal is to produce 500,000 doses of inactivated monovalent whole-virion influenza vaccine per year by 2012, and progressively increase capacity to more than 1 million doses to protect essential populations in Viet Nam in the event of an influenza pandemic. The WHO seed grants, supplemented by other international partner support, enabled IVAC to build in a very short time an influenza vaccine manufacturing plant under Good Manufacturing Practice and relevant biosafety standards, a waste treatment system and a dedicated chicken farm for high-quality eggs. Much of the equipment and instrumentation required for vaccine production has been installed and tested for functional operation. Staff have been trained on site and at specialized courses which provided comprehensive manuals on egg-based manufacturing processes and biosafety. Following process validation, clinical trials will start in 2011 and the first domestic influenza vaccine doses are expected in 2012. PMID:21684426

Hoa, L K; Hiep, L V; Be, L V

2011-07-01

63

Development of Special Biological Products.  

National Technical Information Service (NTIS)

Tissue Culture: Two production lots of FRhL-2 and one of MRC-5 were stabilized and frozen this year. A new production seed for MRC-5 was processed at Pass 14. VEE (C-84) Vaccine Development: One lot of vaccine (C-84-7) was prepared this year to satisfy th...

D. E. Craig J. L. DeMeio G. R. French C. K. Lee W. J. Thomas

1982-01-01

64

FDA Briefing Document: Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... vaccines against Influenza A virus subtypes not included in a licensed seasonal vaccine, but manufactured according to the same process ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

65

Production of glycoprotein vaccines in Escherichia coli  

Microsoft Academic Search

BACKGROUND: Conjugate vaccines in which polysaccharide antigens are covalently linked to carrier proteins belong to the most effective and safest vaccines against bacterial pathogens. State-of-the art production of conjugate vaccines using chemical methods is a laborious, multi-step process. In vivo enzymatic coupling using the general glycosylation pathway of Campylobacter jejuni in recombinant Escherichia coli has been suggested as a simpler

Julian Ihssen; Michael Kowarik; Sandro Dilettoso; Cyril Tanner; Michael Wacker; Linda Thöny-Meyer

2010-01-01

66

Marketed Products  

Center for Biologics Evaluation and Research (CBER)

... Products; Vaccines, Blood & Biologics; Animal & Veterinary; Cosmetics; Tobacco Products. Vaccines, Blood & Biologics. Print; ... More results from www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts

67

The use of vaccination in poultry production.  

PubMed

Poultry vaccines are widely applied to prevent and control contagious poultry diseases. Their use in poultry production is aimed at avoiding or minimising the emergence of clinical disease at farm level, thus increasing production. Vaccines and vaccination programmes vary broadly in regard to several local factors (e.g. type of production, local pattern of disease, costs and potential losses) and are generally managed by the poultry industry. In the last decade, the financial losses caused by the major epidemic diseases of poultry (avian influenza and Newcastle disease) have been enormous for both the commercial and the public sectors. Thus, vaccination should also be applied in the framework of poultry disease eradication programmes at national or regional levels under the official supervision of public Veterinary Services. This paper provides insight on the use of vaccination for the control of poultry infections, with particular emphasis on the control of transboundary poultry diseases. PMID:17633308

Marangon, S; Busani, L

2007-04-01

68

Vaccines and Biological Advisory Committee Meeting  

Center for Biologics Evaluation and Research (CBER)

Text Version... Nigeria. ... Ethnic/Racial Distribution: Pooled Safety Analysis. ... person years of follow-up); Comparable AE/SAE rates in vaccine and control groups; ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

69

Systems Biology of Seasonal Influenza Vaccination in Humans  

PubMed Central

We used a systems biological approach to study innate and adaptive responses to influenza vaccination in humans, during 3 consecutive influenza seasons. Healthy adults were vaccinated with inactivated (TIV) or live attenuated (LAIV) influenza vaccines. TIV induced greater antibody titers and enhanced numbers of plasmablasts than LAIV. In TIV vaccinees, early molecular signatures correlated with, and accurately predicted, later antibody titers in two independent trials. Interestingly, the expression of Calcium/calmodulin-dependent kinase IV (CamkIV) at day 3 was inversely correlated with later antibody titers. Vaccination of CamkIV ?/? mice with TIV induced enhanced antigen-specific antibody titers, demonstrating an unappreciated role for CaMKIV in the regulation of antibody responses. Thus systems approaches can predict immunogenicity, and reveal new mechanistic insights about vaccines.

Nakaya, Helder I; Wrammert, Jens; Lee, Eva K; Racioppi, Luigi; Marie-Kunze, Stephanie; Haining, W. Nicholas; Means, Anthony R; Kasturi, Sudhir P; Khan, Nooruddin; Li, Gui-Mei; McCausland, Megan; Kanchan, Vibhu; Kokko, Kenneth E; Li, Shuzhao; Elbein, Rivka; Mehta, Aneesh K; Aderem, Alan; Subbarao, Kanta; Ahmed, Rafi; Pulendran, Bali

2011-01-01

70

Influenza Vaccine Responses  

Center for Biologics Evaluation and Research (CBER)

Text VersionInfluenza Vaccine Responses ... Prepared for Vaccines and Related Biological Products Advisory Committee ... Inactivated Vaccine Serology Studies . ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

71

Biological Product Deviation Guidances & Rules  

Center for Biologics Evaluation and Research (CBER)

... Biological Product Deviation Guidances & Rules. ... (301) 827-6220. bp_deviations@fda.hhs.gov. Biological Product Deviation Reporting (CBER) ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/reportaproblem

72

Security Resources For Manufacturers of Biological Products  

Center for Biologics Evaluation and Research (CBER)

... Section Contents Menu. Safety & Availability (Biologics). Biologic Product Security. -. Security Resources For Manufacturers of Biological Products. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/productsecurity

73

Rabies vaccine  

Microsoft Academic Search

Rabies vaccines produced by means of molecular biology are described. Recombinant vaccines employing either viruses as vectors\\u000a (vaccinia, adenovirus, poxvirus, baculovirus, plant viruses) or a plasmid vector carrying the rabies virus glycoprotein gene\\u000a are discussed. Synthetic peptide technology directed to rabies vaccine production is also presented.

Claudio Carlos Paolazzi; Oscar Pérez; Javier De Filippo

1999-01-01

74

September 21, 2010 Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

... & Special Pathogens, Division of Bacterial, Parasitic, & Allergenic Products; Laboratory of Hepatitis Viruses, and Laboratory of Vector Borne Virus ... More results from www.fda.gov/advisorycommittees/calendar

75

Adjuvant solution for pandemic influenza vaccine production  

PubMed Central

Extensive preparation is underway to mitigate the next pandemic influenza outbreak. New vaccine technologies intended to supplant egg-based production methods are being developed, with recombinant hemagglutinin (rHA) as the most advanced program for preventing seasonal and avian H5N1 Influenza. Increased efforts are being focused on adjuvants that can broaden vaccine immunogenicity against emerging viruses and maximize vaccine supply on a worldwide scale. Here, we test protection against avian flu by using H5N1-derived rHA and GLA-SE, a two-part adjuvant system containing glucopyranosyl lipid adjuvant (GLA), a formulated synthetic Toll-like receptor 4 agonist, and a stable emulsion (SE) of oil in water, which is similar to the best-in-class adjuvants being developed for pandemic flu. Notably, a single submicrogram dose of rH5 adjuvanted with GLA-SE protects mice and ferrets against a high titer challenge with H5N1 virus. GLA-SE, relative to emulsion alone, accelerated induction of the primary immune response and broadened its durability against heterosubtypic H5N1 virus challenge. Mechanistically, GLA-SE augments protection via induction of a Th1-mediated antibody response. Innate signaling pathways that amplify priming of Th1 CD4 T cells will likely improve vaccine performance against future outbreaks of lethal pandemic flu.

Clegg, Christopher H.; Roque, Richard; Van Hoeven, Neal; Perrone, Lucy; Baldwin, Susan L.; Rininger, Joseph A.; Bowen, Richard A.; Reed, Steven G.

2012-01-01

76

Yellow fever vaccination centers: concurrent vaccinations and updates on mosquito biology.  

PubMed

Mandatory visits to immunization centers that offer pre-travel Yellow fever vaccine to prospective travelers would be useful for briefing the basics of the biology of the mosquito responsible for Yellow fever spread. Pre- travel knowledge on the day-time rather the nocturnal biting habit of the mosquitoes of Aedes species would prevent from bites of the mosquitoes responsible for the spread of viruses causing Yellow fever, dengue or Chikungunya infection. PMID:22613468

Arya, Subhash C; Agarwal, Nirmala

2012-05-20

77

Electronic Submission of Biological Product Deviation Reports ...  

Center for Biologics Evaluation and Research (CBER)

... Electronic Submission of Biological Product Deviation Reports (eBPDR). Biological Product Deviation Reports can now ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/reportaproblem

78

Biological production of hydrogen  

SciTech Connect

All Phase I objectives were satisfactorily achieved. Stoichiometric yields of hydrogen were obtained from CO with R. rubrum. Fast growth was observed on synthesis gas only; however, growth was maximized with a small amount of yeast extract at 30[degrees]C and pH 7. Intrinsic kinetic parameters were determined and showed that fast hydrogen production rates are possible. The Phase II research program concentrated on defining the optimal culture and bioreactor for hydrogen production. To insure that the best possible system was developed, cultures were screened for enzyme activity and hydrogen production. Promising cultures were optimized for hydrogen yield and CO conversion. Bioreactors that achieved high mass transfer rates, as well as high cell concentrations, were studied. Advanced bioreactor concepts, such as solid-state fermentation, non-aqueous fermentation, and high pressure fermentation were applied to these reactors to enhance mass transport. Process design and economic evaluations of the various alternatives were used to guide the research program. A new bacterial culture has been isolated from natural sources which consumes CO rapidly and gives high hydrogen yields. The new isolate, ERIH2, is able to utilize a variety of sugars as growth substrates and, unlike R. rubrum, does not require light for growth. The yield of H[sub 2] by ERIH2 reach 100 percent. Typical H[sub 2] yields by R. rubrum were 75--85 percent.

Clausen, E.C.; Gaddy, J.L.; Ko, C.W.

1992-01-01

79

Influenza Vaccines: From Surveillance Through Production to Protection  

PubMed Central

Influenza is an important contributor to population and individual morbidity and mortality. The current influenza pandemic with novel H1N1 has highlighted the need for health care professionals to better understand the processes involved in creating influenza vaccines, both for pandemic as well as for seasonal influenza. This review presents an overview of influenza-related topics to help meet this need and includes a discussion of the burden of disease, virology, epidemiology, viral surveillance, and vaccine strain selection. We then present an overview of influenza vaccine—related topics, including vaccine production, vaccine efficacy and effectiveness, influenza vaccine misperceptions, and populations that are recommended to receive vaccination. English-language articles in PubMed published between January 1, 1970, and October 7, 2009, were searched using key words human influenza, influenza vaccines, influenza A, and influenza B.

Tosh, Pritish K.; Jacobson, Robert M.; Poland, Gregory A.

2010-01-01

80

9 CFR 112.6 - Packaging biological products.  

Code of Federal Regulations, 2010 CFR

...required number of containers of the proper amount of diluent as specified in the filed Outline of Production: (1) Marek's Disease Vaccine. (2) Poultry vaccines administered to individual birds using automatic vaccinating equipment....

2009-01-01

81

9 CFR 112.6 - Packaging biological products.  

Code of Federal Regulations, 2010 CFR

...required number of containers of the proper amount of diluent as specified in the filed Outline of Production: (1) Marek's Disease Vaccine. (2) Poultry vaccines administered to individual birds using automatic vaccinating equipment....

2010-01-01

82

Automated production of plant-based vaccines and pharmaceuticals.  

PubMed

A fully automated "factory" was developed that uses tobacco plants to produce large quantities of vaccines and other therapeutic biologics within weeks. This first-of-a-kind factory takes advantage of a plant viral vector technology to produce specific proteins within the leaves of rapidly growing plant biomass. The factory's custom-designed robotic machines plant seeds, nurture the growing plants, introduce a viral vector that directs the plant to produce a target protein, and harvest the biomass once the target protein has accumulated in the plants-all in compliance with Food and Drug Administration (FDA) guidelines (e.g., current Good Manufacturing Practices). The factory was designed to be time, cost, and space efficient. The plants are grown in custom multiplant trays. Robots ride up and down a track, servicing the plants and delivering the trays from the lighted, irrigated growth modules to each processing station as needed. Using preprogrammed robots and processing equipment eliminates the need for human contact, preventing potential contamination of the process and economizing the operation. To quickly produce large quantities of protein-based medicines, we transformed a laboratory-based biological process and scaled it into an industrial process. This enables quick, safe, and cost-effective vaccine production that would be required in case of a pandemic. PMID:23015521

Wirz, Holger; Sauer-Budge, Alexis F; Briggs, John; Sharpe, Aaron; Shu, Sudong; Sharon, Andre

2012-09-26

83

Candidate cell substrates, vaccine production, and transmissible spongiform encephalopathies.  

PubMed

Transmissible spongiform encephalopathy (TSE) agents have contaminated human tissue-derived medical products, human blood components, and animal vaccines. The objective of this study was to determine the potential susceptibility to infection of 5 cell lines used or proposed for manufacture of biological products, as well as other lines. Cell lines were exposed to the infectious agents of sporadic and variant Creutzfeldt-Jakob disease and bovine spongiform encephalopathy (BSE). Exposed cultures were tested for TSE-associated prion protein (PrP(TSE)) and TSE infectivity by assay in rodents and nonhuman primates. No PrP(TSE) or infectivity has been detected in any exposed cell line under study so far. Animals inoculated with BSE brain homogenate developed typical spongiform encephalopathy. In contrast, animals inoculated with cells exposed to the BSE agent remained asymptomatic. All cell lines we studied resisted infection with 3 TSE agents, including the BSE agent. PMID:22172513

Piccardo, Pedro; Cervenakova, Larisa; Vasilyeva, Irina; Yakovleva, Oksana; Bacik, Igor; Cervenak, Juraj; McKenzie, Carroll; Kurillova, Lubica; Gregori, Luisa; Pomeroy, Kitty; Asher, David M

2011-12-01

84

Production of a falcon herpesvirus vaccine.  

PubMed

Ten common kestrels (Falco tinnunculus) were used for this falcon herpes vaccine experiment. Four kestrels were subcutaneously given 1 ml of an attenuated falcon herpesvirus that had originally been isolated from the liver of an American prairie falcon (Falco mexicanus). This virus was then passaged 100 times on chicken embryo fibroblast cells (CEF-cells). Another 4 kestrels were given subcutaneously an inactivated falcon herpesvirus vaccine derived from the same American field strain. This vaccine was concentrated, inactivated by heat and betapropiolactone and emulsified in complete Freund's adjuvans. Two further kestrels served as controls and were not vaccinated. Twenty-one days after vaccination, all 10 kestrels were challenged with passage 3 of the American falcon herpesvirus. The 2 control kestrels died 6 days after challenge and 3 of those given the inactivated herpes vaccine died 9 days after challenge, with typical lesions of herpesvirus inclusion body hepatitis. Before the vaccination experiment, all 10 kestrels were free of serum neutralising antibodies to the falcon herpesvirus. Twenty-one days after vaccination, all 4 kestrels vaccinated with the attenuated vaccine, and one vaccinated with the killed vaccine, had seroconverted, having shown no symptoms to the challenge with a low passage virulent American herpesvirus strain. Following the challenge their antibody titres to falcon herpesvirus increased. No herpesvirus was isolated from any of the cloacal swabs taken during this experiment, indicating that there is no danger for any other birds from the attenuated herpesvirus vaccine. This experiment clearly shows that an attenuated falcon herpesvirus vaccine can protect kestrels from fatal inclusion body hepatitis. PMID:10507183

Wernery, U; Wernery, R; Kinne, J

1999-09-01

85

Vaccines and Related Biological Products Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. ... More results from www.fda.gov/downloads/advisorycommittees/calendar

86

Vaccines and Related Biological Products Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... The reporting period for non-serious AEs was the time period from the first injection (Week 0) until 4 weeks after the third injection (Week 28). ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

87

Vaccines and Related Biological Products Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone ... More results from www.fda.gov/downloads/advisorycommittees/calendar

88

Vaccines and Related Biological Products Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... For those unable to attend in person, the meeting will also be Web cast. The link for the Web cast is available at ... Please visit our Web site at Page 4. ... More results from www.fda.gov/downloads/advisorycommittees/calendar

89

Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles  

PubMed Central

As history has demonstrated, post-approval obstacles can impede a vaccine’s use and potentially lead to its withdrawal. Addressing these potential obstacles when changes in a vaccine’s technology can still be easily made may improve a vaccine’s chances of success. Augmented vaccine target product profiles (TPPs) can help vaccine scientists better understand and anticipate these obstacles and galvanize conversations among various vaccine stakeholders (e.g., scientists, marketers, business development managers, policy makers, public health officials, health care workers, third party payors, etc.) earlier in a vaccine’s development.

Lee, Bruce Y.; Burke, Donald S.

2012-01-01

90

Synthetic biology guides biofuel production.  

PubMed

The advancement of microbial processes for the production of renewable liquid fuels has increased with concerns about the current fuel economy. The development of advanced biofuels in particular has risen to address some of the shortcomings of ethanol. These advanced fuels have chemical properties similar to petroleum-based liquid fuels, thus removing the need for engine modification or infrastructure redesign. While the productivity and titers of each of these processes remains to be improved, progress in synthetic biology has provided tools to guide the engineering of these processes through present and future challenges. PMID:20827393

Connor, Michael R; Atsumi, Shota

2010-08-12

91

Synthetic Biology Guides Biofuel Production  

PubMed Central

The advancement of microbial processes for the production of renewable liquid fuels has increased with concerns about the current fuel economy. The development of advanced biofuels in particular has risen to address some of the shortcomings of ethanol. These advanced fuels have chemical properties similar to petroleum-based liquid fuels, thus removing the need for engine modification or infrastructure redesign. While the productivity and titers of each of these processes remains to be improved, progress in synthetic biology has provided tools to guide the engineering of these processes through present and future challenges.

Connor, Michael R.; Atsumi, Shota

2010-01-01

92

February 18-19, 2009: Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

... selection of strains to be included in the influenza virus vaccine for the ... the utility of adding a second B strain to current seasonal influenza vaccines. ... More results from www.fda.gov/advisorycommittees/calendar

93

131st Meeting of the Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... available hepatitis B vaccines? Page 62. 59 DR. ... She received an inactivated influenza vaccine 105 days after HEPLISAV injection two. Five days ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

94

Vaccine stability study design and analysis to support product licensure.  

PubMed

Stability evaluation supporting vaccine licensure includes studies of bulk intermediates as well as final container product. Long-term and accelerated studies are performed to support shelf life and to determine release limits for the vaccine. Vaccine shelf life is best determined utilizing a formal statistical evaluation outlined in the ICH guidelines, while minimum release is calculated to help assure adequate potency through handling and storage of the vaccine. In addition to supporting release potency determination, accelerated stability studies may be used to support a strategy to recalculate product expiry after an unintended temperature excursion such as a cold storage unit failure or mishandling during transport. Appropriate statistical evaluation of vaccine stability data promotes strategic stability study design, in order to reduce the uncertainty associated with the determination of the degradation rate, and the associated risk to the customer. PMID:19717312

Schofield, Timothy L

2009-08-29

95

Vero cell platform in vaccine production: moving towards cell culture-based viral vaccines.  

PubMed

The development of cell culture systems for virus propagation has led to major advances in virus vaccine development. Primary and diploid cell culture systems are now being replaced by the use of continuous cell lines (CCLs). These substrates are gaining increasing acceptance from regulatory authorities as improved screening technologies remove fears regarding their potential oncogenic properties. The Vero cell line is the most widely accepted CCL by regulatory authorities and has been used for over 30 years for the production of polio and rabies virus vaccines. The recent licensure of a Vero cell-derived live virus vaccine (ACAM2000, smallpox vaccine) has coincided with an explosion in the development of a range of new viral vaccines, ranging from live-attenuated pediatric vaccines against rotavirus infections to inactivated whole-virus vaccines against H5N1 pandemic influenza. These developments have illustrated the value of this cell culture platform in the rapid development of vaccines against a range of virus diseases. PMID:19397417

Barrett, P Noel; Mundt, Wolfgang; Kistner, Otfried; Howard, M Keith

2009-05-01

96

Biological and phylogenetic characterization of a genotype VII Newcastle disease virus from Venezuela: Efficacy of vaccination  

Technology Transfer Automated Retrieval System (TEKTRAN)

Here we describe the characterization a virulent genotype VII Newcastle disease virus (NDV) from Venezuela and evaluate the efficacy of heterologous genotype commercial vaccination under field and controlled rearing conditions. Biological pathotyping and molecular analysis were applied. Results sh...

97

Natural products from synthetic biology.  

PubMed

DNA sequencing has uncovered microbial secondary metabolic potential that never surfaced in fermentation based screens. Deep and cheap sequencing of a genus such as Streptomyces can rapidly expose hundreds of metabolic genes and operons. Meanwhile, synthetic biologists, in their quest to engineer advanced biofuels, are mastering metabolic engineering. Natural products, a reliable source of new therapeutic leads for many years, have fallen into disfavor with drug discoverers partly because these molecules are rarely available as pure compounds and sourcing is often problematic. The convergence of next generation sequencing and synthetic biology, along with less spectacular progress in analytic technologies such as mass spectroscopy, opens the door to the creation of large, reliable libraries of pure natural products for drug discovery. PMID:21684801

Mitchell, Wayne

2011-08-01

98

Innovative vaccine production technologies: The evolution and value of vaccine production technologies  

Microsoft Academic Search

This review paper provides an overview of innovative technologies designed to produce bacterial, viral, recombinant subunit,\\u000a and polysaccharide vaccines, as well as combination vaccines. Advances in this field are illustrated by vaccines against DTP\\u000a (diphtheria-tetanus-pertussis), influenza, hepatitis B (HepB) and typhoid fever. In addition, technological trends regarding\\u000a antigens, adjuvants, and preservatives in vaccines are discussed. The progress achieved in vaccine

KyungDong Bae; JunYoul Choi; YangSuk Jang; SangJeom Ahn; ByungKi Hur

2009-01-01

99

Identifying Recalled Products  

MedlinePLUS Videos and Cool Tools

... Most Popular Searches Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics ... Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products Vaccines, Blood & Biologics Identifying ...

100

Facilitating Influenza Virus Vaccine Production by Optimizing ...  

Center for Biologics Evaluation and Research (CBER)

... 1 with a disrupted nuclear localization signal. Xie H, Lin Z, Mosier PD, Desai UR, Gao Y. Vaccine 2012 Dec 17;31(1):207 ... More results from www.fda.gov/biologicsbloodvaccines/scienceresearch/biologicsresearchareas

101

Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles  

Microsoft Academic Search

As history has demonstrated, post-approval obstacles can impede a vaccine's use and potentially lead to its withdrawal. Addressing these potential obstacles when changes in a vaccine's technology can still be easily made may improve a vaccine's chances of success. Augmented vaccine target product profiles (TPPs) can help vaccine scientists better understand and anticipate these obstacles and galvanize conversations among various

Bruce Y. Lee; Donald S. Burke

2010-01-01

102

Biological safety concepts of genetically modified live bacterial vaccines  

Microsoft Academic Search

Live vaccines possess the advantage of having access to induce cell-mediated and antibody-mediated immunity; thus in certain cases they are able to prevent infection, and not only disease. Furthermore, live vaccines, particularly bacterial live vaccines, are relatively cheap to produce and easy to apply. Hence they are suitable to immunize large communities or herds. The induction of both cell-mediated immunity

Joachim Frey

2007-01-01

103

Understanding the immune response to seasonal influenza vaccination in older adults: a systems biology approach  

PubMed Central

Annual vaccination against seasonal influenza is recommended to decrease disease-related mortality and morbidity. However, one population that responds suboptimally to influenza vaccine is adults over the age of 65 years. The natural aging process is associated with a complex deterioration of multiple components of the host immune system. Research into this phenomenon, known as immunosenescence, has shown that aging alters both the innate and adaptive branches of the immune system. The intricate mechanisms involved in immune response to influenza vaccine, and how these responses are altered with age, have led us to adopt a more encompassing systems biology approach to understand exactly why the response to vaccination diminishes with age. Here, the authors review what changes occur with immunosenescence, and some immunogenetic factors that influence response, and outline the systems biology approach to understand the immune response to seasonal influenza vaccination in older adults.

Lambert, Nathaniel D; Ovsyannikova, Inna G; Pankratz, V Shane; Jacobson, Robert M; Poland, Gregory A

2012-01-01

104

Smallpox and biological warfare: the case for abandoning vaccination of military personnel.  

PubMed Central

Smallpox was officially declared eradicated from the world in 1980. Earlier, in 1972, over 50 nations signed the Biological Weapons Convention renouncing this entire category of weapons. Despite this international agreement, both the United States and the Soviet Union continue to vaccinate their military troops against smallpox, thus implying that each fears the other might still use it in biological warfare. Vaccination is not a harmless procedure, and vaccinia infections continue to be reported in troops and their contacts. Negotiating an end to the vaccination of troops would be a final step in ending the fear of smallpox.

Capps, L; Vermund, S H; Johnsen, C

1986-01-01

105

IRRIGATION FOR VACCINE PRODUCTION IN PHARMACEUTICAL TOBACCO  

Technology Transfer Automated Retrieval System (TEKTRAN)

Biotechnology companies in North America and Europe have engineered plants to produce recombinant proteins for therapeutic drugs and vaccines. Chlorogen, Inc. located in St. Louis, Missouri, inserted the protective antigen (PA) gene from Bacillus anthracis into tobacco (Nicotiana tabacum cv LAMD 60...

106

Proprietary Name Review for Biologic Products  

Center for Biologics Evaluation and Research (CBER)

... CBER's Advertising and Promotional Labeling Branch (APLB) reviews and evaluates proposed proprietary names for biological products in ... More results from www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/advertisinglabelingpromotionalmaterials

107

Biological Product Withdrawal of Carimune NF Immune ...  

Center for Biologics Evaluation and Research (CBER)

... Biological Product Withdrawal of Carimune NF Immune Globulin Intravenous- ZLB Behring. DATE WITHDRAWAL INITIATED: February 21, 2007. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/recalls

108

February 28-29, 2012: Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

... discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2012-2013 influenza season. ... More results from www.fda.gov/advisorycommittees/calendar

109

128th Meeting of the Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Diseases CDC 12:00 pm DoD Vaccine Effectiveness Report Ronald L. Burke, DVM, DrPH MAJ, USA Head, Dept. of Respiratory ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

110

November 14-15, 2012: Vaccines and Related Biological ...  

Center for Biologics Evaluation and Research (CBER)

... 15, 2012, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine ... More results from www.fda.gov/advisorycommittees/calendar

111

Foods as production and delivery vehicles for human vaccines.  

PubMed

Vaccination is a great asset for eradication of infectious diseases in humans and animals. With the prevalence of antibiotic resistant bacterial strains and an alarming increase in new and re-emerging pathogens, the need for vaccination continues to be a high priority for mammalian diseases. In the last several years, a novel approach for developing improved mucosal subunit vaccines has emerged by exploiting the use of genetically modified plants. It has been demonstrated that plant-derived antigens are functionally similar to conventional vaccines and can induce neutralizing antibodies in mammalian hosts. Using genetically engineered plants for the production of immunogenic peptides also provides a new approach for the delivery of a plant-based subunit vaccine, i.e., oral delivery, provided these immunogenic peptides are expressed in an edible part of the plant, such as grain or fruit. Thus, food crops can play a significant new role in promoting human health by serving as vehicles for both production and delivery of vaccines. PMID:12071307

Korban, Schuyler S; Krasnyanski, Sergei F; Buetow, Dennis E

2002-06-01

112

Warning on Body Building Products  

MedlinePLUS Videos and Cool Tools

... Most Popular Searches Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics ... Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products Vaccines, Blood & Biologics ? - Resources ...

113

Enhancing the role of veterinary vaccines reducing zoonotic diseases of humans: linking systems biology with vaccine development.  

PubMed

The aim of research on infectious diseases is their prevention, and brucellosis and salmonellosis as such are classic examples of worldwide zoonoses for application of a systems biology approach for enhanced rational vaccine development. When used optimally, vaccines prevent disease manifestations, reduce transmission of disease, decrease the need for pharmaceutical intervention, and improve the health and welfare of animals, as well as indirectly protecting against zoonotic diseases of people. Advances in the last decade or so using comprehensive systems biology approaches linking genomics, proteomics, bioinformatics, and biotechnology with immunology, pathogenesis and vaccine formulation and delivery are expected to enable enhanced approaches to vaccine development. The goal of this paper is to evaluate the role of computational systems biology analysis of host:pathogen interactions (the interactome) as a tool for enhanced rational design of vaccines. Systems biology is bringing a new, more robust approach to veterinary vaccine design based upon a deeper understanding of the host-pathogen interactions and its impact on the host's molecular network of the immune system. A computational systems biology method was utilized to create interactome models of the host responses to Brucella melitensis (BMEL), Mycobacterium avium paratuberculosis (MAP), Salmonella enterica Typhimurium (STM), and a Salmonella mutant (isogenic ?sipA, sopABDE2) and linked to the basis for rational development of vaccines for brucellosis and salmonellosis as reviewed by Adams et al. and Ficht et al. [1,2]. A bovine ligated ileal loop biological model was established to capture the host gene expression response at multiple time points post infection. New methods based on Dynamic Bayesian Network (DBN) machine learning were employed to conduct a comparative pathogenicity analysis of 219 signaling and metabolic pathways and 1620 gene ontology (GO) categories that defined the host's biosignatures to each infectious condition. Through this DBN computational approach, the method identified significantly perturbed pathways and GO category groups of genes that define the pathogenicity signatures of the infectious agent. Our preliminary results provide deeper understanding of the overall complexity of host innate immune response as well as the identification of host gene perturbations that defines a unique host temporal biosignature response to each pathogen. The application of advanced computational methods for developing interactome models based on DBNs has proven to be instrumental in elucidating novel host responses and improved functional biological insight into the host defensive mechanisms. Evaluating the unique differences in pathway and GO perturbations across pathogen conditions allowed the identification of plausible host-pathogen interaction mechanisms. Accordingly, a systems biology approach to study molecular pathway gene expression profiles of host cellular responses to microbial pathogens holds great promise as a methodology to identify, model and predict the overall dynamics of the host-pathogen interactome. Thus, we propose that such an approach has immediate application to the rational design of brucellosis and salmonellosis vaccines. PMID:21651944

Adams, L Garry; Khare, Sangeeta; Lawhon, Sara D; Rossetti, Carlos A; Lewin, Harris A; Lipton, Mary S; Turse, Joshua E; Wylie, Dennis C; Bai, Yu; Drake, Kenneth L

2011-06-07

114

MMR Vaccine (Measles, Mumps, and Rubella)  

MedlinePLUS

Mumpsvax® Mumps Vaccine ... Biavax® II (as a combination product containing Mumps Vaccine, Rubella Vaccine) ... II (as a combination product containing Measles Vaccine, Mumps Vaccine, Rubella Vaccine)

115

Electrophilic natural products and their biological targets.  

PubMed

The study of biologically active natural products has resulted in seminal contributions to our understanding of living systems. In the case of electrophilic natural products, the covalent nature of their interaction has largely facilitated the identification of their biological binding partners. In this review, we provide a comprehensive compilation of electrophilic natural products from all major chemical classes together with their biological targets. Covering Michael acceptor systems, ring-strained compounds and other electrophiles, such as esters or carbamates, we highlight representative and instructive examples for over 20 electrophilic moieties. The fruitful cooperation of natural product chemistry, medicinal chemistry and chemical biology has produced a collection of well-studied examples for how electrophilic natural products exert their biological functions that range from antibiotic to antitumor effects. Special emphasis is put on the elucidation of their respective biological targets via activity-based protein profiling, which together with the recent advancements in mass spectrometry has been crucial to the success of the field. The wealth of naturally occurring electrophilic moieties and their chemical complexity enables binding of a large variety of biological targets, such as enzymes of all classes, nonenzymatic proteins, DNA and other cellular compounds. With approximately 30,000 genes in the human genome but only 266 confirmed protein drug targets, the study of biologically active, electrophilic natural products has the potential to provide insights into fundamental biological processes and to greatly aid the discovery of new drug targets. PMID:22504336

Gersch, Malte; Kreuzer, Johannes; Sieber, Stephan A

2012-04-16

116

New medicinal plants for the production of vaccines  

Microsoft Academic Search

.  During the last decade a large number of biopharmaceuticals has entered the market, mainly protein-based pharmaceuticals like\\u000a hormones, cytokines, antibodies, and vaccines. Several hundred products are currently in clinical trials and already every\\u000a fourth approval for genuinely new pharmaceuticals is made for a recombinant product. To meet the increasing demand for recombinant\\u000a protein production capacity alternative technologies are urgently needed.

K. Glenz; H. Warzecha

2006-01-01

117

On the interchangeability of biologic drug products.  

PubMed

Interchangeability of drug products has very different features with small molecules and with biologicals. With small-molecule drugs, a statement of bioequivalence generally indicates therapeutic equivalence and interchangeability. In contrast, with the much more sensitive and complicated biological drugs, a declaration of biosimilarity emphatically does not imply that a patient could be switched from one product to another. Both formulations may be prescribed and administered to subjects who have not received yet the drug in any of its forms. However, regulatory agencies have been very cautious about enabling and permitting interchangeability. Notably, the Biologics Price Competition and Innovation Act of the USA sets very formidable and severe conditions for enabling the interchangeability of biological drug products. The background and conditions for the interchangeability of both small-molecule and biologic drug products are presented in detail. PMID:22911936

Endrenyi, Laszlo; Chang, Chiann; Chow, Shein-Chung; Tothfalusi, Laszlo

2012-08-22

118

Use of viral vectors for vaccine production in plants  

Microsoft Academic Search

The small size of plant viral genomes, the ease with which they can be manipulated, and the simplicity of the infection process is making the viral vectors an attractive alternative to the transgenic systems for the expression of foreign proteins in plants. One use of these virus expression systems is for vaccine production. There are two basic types of viral

M Carmen Cañizares; Liz Nicholson; George P Lomonossoff

2005-01-01

119

Corn as a production system for human and animal vaccines  

Microsoft Academic Search

The synthesis of selected antigens in plants and their oral delivery has great potential for reducing the costs of vaccine production and administration. The application of this technology requires antigen concentrations in final plant material to be uniform to ensure consistent dosing. In addition, antigen levels should be such as to allow the volume of each dose, containing a set

Stephen J Streatfield; Christopher A Brooks; Donna K Barker; Miranda L Poage; Jocelyne M Mayor; Barry J Lamphear; Carol F Drees; Joseph M Jilka; Elizabeth E Hood; John A Howard

2003-01-01

120

Potency measurement of pertussis vaccines and consistency in production.  

PubMed

If one accepts the minimum requirement of 4 i.u. shd-1 for the potency of pertussis vaccine--and there is no convincing evidence to reject this--the usual MPT with 20 mice per dilution offers a sufficient guarantee that no vaccines with too low potency will be accepted, provided that the consistency in production has been sufficiently proven. As higher concentrations than necessary should be avoided in view of the undesirable side-effects, the establishment of requirements for the lower level of the 95% confidence limits might, however, entail exactly this risk. PMID:536376

van Ramshorst, J D; Cohen, H; van Hemert, P A

1979-01-01

121

Two decades of commitment to malaria vaccine development: GlaxoSmithKline Biologicals.  

PubMed

GlaxoSmithKline Biologicals (GSK) is committed to the development of a safe and effective malaria vaccine. Its research program in this field was initiated in 1984 and has been continuously active to this day, making it unparalleled within the vaccine industry. Although it works in partnerships with several leading organizations from the public sector, this effort has required GSK to invest major financial and human resource commitments, and its partners rely heavily on the company's global infrastructure and expertise in research, advanced clinical development, regulatory, large-scale manufacturing, and commercialization. Through GSK's pioneering business model and working in partnership with global vaccine funding agencies, the company is committed to seeing that, once approved, a safe and effective malaria vaccine will be available to everyone that needs it. PMID:18165505

Ballou, W Ripley; Cahill, Conor P

2007-12-01

122

Vaccine Production Utilizing the Potential of Microcarriers in Disposable Bioreactor  

Microsoft Academic Search

\\u000a The vast majority of production scale processes using animal cells is based on stirred tank technology. Some important cell-lines\\u000a of industrial interest are anchorage dependent while others grow in suspension. For anchorage dependent cells microcarrier\\u000a technology has proved to be worthwhile. During the last century the number of relevant processes has developed from production\\u000a of viral vaccines to monoclonal antibodies

J. E. Schouwenberg; T. Velden-de Groot; G. Blueml

123

Scale-down of the inactivated polio vaccine production process.  

PubMed

The anticipated increase in the demand for inactivated polio vaccines resulting from the success in the polio eradication program requires an increase in production capacity and cost price reduction of the current inactivated polio vaccine production processes. Improvement of existing production processes is necessary as the initial process development has been done decades ago. An up-to-date lab-scale version encompassing the legacy inactivated polio vaccine production process was set-up. This lab-scale version should be representative of the large scale, meaning a scale-down model, to allow experiments for process optimization that can be readily applied. Initially the separate unit operations were scaled-down at setpoint. Subsequently, the unit operations were applied successively in a comparative manner to large-scale manufacturing. This allows the assessment of the effects of changes in one unit operation to the consecutive units at small-scale. Challenges in translating large-scale operations to lab-scale are discussed, and the concessions that needed to be made are described. The current scale-down model for cell and virus culture (2.3-L) presents a feasible model with its production scale counterpart (750-L) when operated at setpoint. Also, the current scale-down models for the DSP unit operations clarification, concentration, size exclusion chromatography, ion exchange chromatography, and inactivation are in agreement with the manufacturing scale. The small-scale units can be used separately, as well as sequentially, to study variations and critical product quality attributes in the production process. Finally, it is shown that the scale-down unit operations can be used consecutively to prepare trivalent vaccine at lab-scale with comparable characteristics to the product produced at manufacturing scale. PMID:23192424

Thomassen, Yvonne E; van 't Oever, Aart G; Vinke, Marian; Spiekstra, Arjen; Wijffels, René H; van der Pol, Leo A; Bakker, Wilfried A M

2012-12-29

124

Vaccine Information  

Center for Drug Evaluation (CDER)

... 2002); Anthrax Vaccine (from FDA's Center for Biologics Evaluation and Research); Smallpox Vaccine (from FDA's Center ... More results from www.fda.gov/drugs/emergencypreparedness/bioterrorismanddrugpreparedness

125

Vascular Responses and Biological Product Safety and ...  

Center for Biologics Evaluation and Research (CBER)

... Vascular Responses and Biological Product Safety and Efficacy. Principal Investigator: Felice D'Agnillo, PhD Office / Division ... More results from www.fda.gov/biologicsbloodvaccines/scienceresearch/biologicsresearchareas

126

A glance at Taenia saginata infection, diagnosis, vaccine, biological control and treatment.  

PubMed

The Taenia saginata taeniasis-cysticercosis complex is a cosmopolitan zoonosis of great medical, veterinary and economic importance where humans play an important role as the carrier of adult stage and cattle as carrier of the larval stage of the parasite. Here we reviewed aspects concerning diagnosis, vaccine development, biological control and treatment of the disease. PMID:20701576

Silva, Claudio V; Costa-Cruz, Julia M

2010-10-01

127

Chapter – 45 Biological Drug Products  

Center for Biologics Evaluation and Research (CBER)

Text Version... Appropriate use of substances required for equipment operations (lubricants, coolants, refrigerants, etc.) contacting products/containers/etc. ... More results from www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation

128

9 CFR 106.1 - Biological products; exemption.  

Code of Federal Regulations, 2010 CFR

... EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN...UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological products; exemption...Administrator may exempt any biological product from...the supervision or control of the...

2010-01-01

129

9 CFR 106.1 - Biological products; exemption.  

Code of Federal Regulations, 2013 CFR

... EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN...UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological products; exemption...Administrator may exempt any biological product from...the supervision or control of the...

2013-01-01

130

9 CFR 106.1 - Biological products; exemption.  

Code of Federal Regulations, 2010 CFR

... EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN...UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological products; exemption...Administrator may exempt any biological product from...the supervision or control of the...

2009-01-01

131

Production of Freeze-Dried Pleuropneumonia Vaccine, and a Mixed Rinderpest-Pleuropneumonia Vaccine at the Central Veterinary Laboratory at Bamako, Republic of Mali.  

National Technical Information Service (NTIS)

Contents: Note on Synthesis and Recommendations; Introduction; Brief Survey of the Central Veterinary Laboratory; Setting up the Production of New Vaccine; Description of Freeze--Dried Antiperipneumonic Vaccine; Description of the Production of Mixed Free...

A. Provost

1988-01-01

132

Production and evaluation of a chromatographically purified Vero cell rabies vaccine (PVRV) in China using microcarrier technology  

PubMed Central

China is a high population country with millions of animal bite cases every year; thus, it is necessary to explore and develop more effective and productive rabies vaccines for human use. To establish a safe, effective, inexpensive and high-yield rabies vaccine, a non-adjuvant purified Vero cell rabies vaccine produced in the SPEEDA PVRV microcarrier bioreactor was developed by Liaoning Chengda Biology Co. Ltd. in China. This vaccine was produced using Vero cells that were cultured in a microcarrier bioreactor. A microcarrier bioreactor containing 25 g/L of Cytodex-1 was used for perfusion culture. The Vero cell culture density was up to 1.2–1.5 × 107 cells/ml, viruses could be constantly harvested for 18–22 days, and the resulting vaccine immunizing potency was ? 4.5 IU/ml. Vaccine safety and immunogenicity post-immunization were also assessed. A total of 602 volunteers were enrolled and divided into two groups that were vaccinated with either SPEEDA PVRV or VERORAB PVRV on days 0, 3, 7, 14 and 28. All subjects vaccinated with SPEEDA PVRV showed no serious local or systemic adverse effects. The positive conversion rate of serum neutralizing antibodies against the rabies virus reached 100% in both the test and control groups (inoculated with VERORAB PVRV) at 14 days and 45 days after vaccination, and no significant difference was found between the neutralizing antibody geometric mean titers (GMTs) of the two groups. SPEEDA PVRV is appropriate for mass production and shows satisfactory clinical safety and immunogenicity for human post-exposure prophylaxis of rabies.

Yu, Pengcheng; Huang, Ying; Zhang, Yibin; Tang, Qing; Liang, Guodong

2012-01-01

133

Biological Properties of Freeze-Dried Attenuated Shigella Vaccines.  

National Technical Information Service (NTIS)

Two Shigella flexneri 2a strains of reduced virulence were lyophilized and their biological properties determined. When tested 19 to 23 months after drying for their ability to cause intestinal inflammation or death in starved guinea pigs, to produce kera...

S. B. Formal E. H. LaBrec T. H. Kent H. C. May J. P. Lowenthal

1966-01-01

134

Biological hydrogen production; fundamentals and limiting processes  

Microsoft Academic Search

Biological hydrogen production has been known for over a century and research directed at applying this process to a practical means of hydrogen fuel production has been carried out for over a quarter century. The various approaches that have been proposed and investigated are reviewed and critical limiting factors identified. The low energy content of solar irradiation dictates that photosynthetic

Patrick C. Hallenbeck; John R. Benemann

2002-01-01

135

[Book review] Developments in biological standardization (Vol. 49): Fish Biologics: Seriodiagnostics and Vaccines, edited by W. Hennessen and D. P. Andersen  

USGS Publications Warehouse

Review of: Developments in Biologicals, Vol. 49. Fish Biologics: Serodiagnostics and Vaccines. International Symposium, Leetown, W.Va., April 1981. Editor(s): Hennessen, W. (Bern); Andersen, D.P. (Leetown, W.Va.); Society/Societies: International Association of Biological Standardization, XII + 496 p., 90 fig., 110 tab., soft cover, 1981. ISBN: 978-3-8055-3471-0.

Anderson, D. P.

1981-01-01

136

Transgenic crops for the production of recombinant vaccines and anti-microbial antibodies.  

PubMed

Plants can be used to produce inexpensive and highly immunogenic vaccines, particularly those aimed against mucosal pathogens. Several plant-derived vaccines have already completed early-phase clinical trials and many more are in the pipeline. The number of products in development has increased as the production technology itself has evolved, reflecting a better understanding of plant molecular biology, more sophisticated genetic engineering techniques, and more recently the development of tools and strategies to increase yields and engineer specific glycan groups on plant-derived glycoproteins. There are many different platforms including whole-plant transient expression systems based on Agrobacterium and/or plant viruses, contained systems based on cultured plant cells or aquatic plants, and stable transgenic plants expressing recombinant proteins in leaves, seeds, fruits or tubers/roots. Although the transient systems are rapid and high-yielding, stable transgenic plants are more scalable and may ultimately provide for more economical large-scale production, which was the original vision of 'molecular farming'. Grain crops such as cereals and legumes are particularly valuable because recombinant proteins expressed in seeds are stable at ambient temperatures and any bioload can be reduced by surface sterilization. Seeds also present interesting formulation options, e.g. the use of seed-specific storage organelles for encapsulation and the slow release of mucosal vaccines. In this article, we review the current status and recent developments in the area of molecular farming in crop plants, focusing particularly on engineered seeds as production and delivery vehicles for recombinant vaccines and antibodies. PMID:21346415

Peters, Jenny; Stoger, Eva

2011-03-01

137

Human adenovirus-vectored foot-and-mouth disease vaccines: establishment of a vaccine product profile through in vitro testing.  

PubMed

Next generation, foot-and-mouth disease (FMD) molecular vaccines based on replication deficient human adenovirus serotype 5 viral vectored delivery of FMD capsid genes (AdFMD) are being developed by the United States Dept. of Homeland Security and industry partners. The strategic goal of this program is to develop AdFMD licensed vaccines for the USA National Veterinary Stockpile for use, if needed, as emergency response tools during an FMD outbreak. This vaccine platform provides a unique opportunity to develop a set of in vitro analytical parameters to generate an AdFMD vaccine product profile to replace the current lot release test for traditional, inactivated FMD vaccines that requires FMDV challenge in livestock. The possibility of an indirect FMD vaccine potency test based on a serological alternative was initially investigated for a lead vaccine candidate, Adt.A24. Results show that serum virus neutralization (SVN) based serology testing for Adt.A24 vaccine lot release is not feasible, at least not in the context of vaccine potency assessment at one week post-vaccination. Thus, an in vitro infectious titer assay (tissue culture infectious dose 50, TCID50) which measures FMD infectious (protein expression) titer was established. Pre-validation results show acceptable assay variability and linearity and these data support further studies to validate the TCID50 assay as a potential potency release test. In addition, a quantitative physiochemical assay (HPLC) and three immunochemical assays (Fluorescent Focus-Forming Unit (FFU); tissue culture expression dose 50 (TCED50); Western blot) were developed for potential use as in vitro assays to monitor AdFMD vaccine lot-to-lot consistency and other potential applications. These results demonstrate the feasibility of using a traditional modified-live vaccine virus infectivity assay in combination with a set of physiochemical and immunochemical tests to build a vaccine product profile that will ensure the each AdFMD vaccine lot released is similar to a reference vaccine of proven clinical safety and efficacy. PMID:22888605

Brake, D A; McIlhaney, M; Miller, T; Christianson, K; Keene, A; Lohnas, G; Purcell, C; Neilan, J; Schutta, C; Barrera, J; Burrage, T; Brough, D E; Butman, B T

2012-01-01

138

Use of viral vectors for vaccine production in plants.  

PubMed

The small size of plant viral genomes, the ease with which they can be manipulated, and the simplicity of the infection process is making the viral vectors an attractive alternative to the transgenic systems for the expression of foreign proteins in plants. One use of these virus expression systems is for vaccine production. There are two basic types of viral system that have been developed for the production of immunogenic peptides and proteins in plants: epitope presentation and polypeptide expression systems. In this review, we discuss advances made in this field. PMID:15877604

Cañizares, M Carmen; Nicholson, Liz; Lomonossoff, George P

2005-06-01

139

Biological engineering for sustainable biomass production  

SciTech Connect

A new discipline has evolved in efforts to engineer photosynthetic production systems that produce biomass feedstocks efficiently, economically and with minimal adverse environmental impact. In this talk an overview is given of how biological engineering systems are designed to produce energy and novel material products within the framework of existing market infrastructure. Practical examples of biological engineering systems which employ components based on genetic engineering, species propagation, modern agricultural techniques, chemical engineering, and mechanical engineering are analyzed for worldwide materials application and environmental conservation. 9 refs., 6 figs.

Shen, S.

1986-09-01

140

9 CFR 103.1 - Preparation of experimental biological products.  

Code of Federal Regulations, 2013 CFR

...organisms or antigens used in biologicals already licensed, shall...to prepare an experimental biological product on licensed premises...the preparation of licensed biological products will not be considered...Management and Budget under control number 0579-0013)...

2013-01-01

141

Licensed Biological Products with Supporting Documents  

Center for Biologics Evaluation and Research (CBER)

... Adenovirus Vaccine Live Oral Type 4 and Type 7, None [Adenovirus Vaccine Live Oral Type 4 and Type 7], Teva Women's Health, Inc./Barr Labs, Inc ... More results from www.fda.gov/biologicsbloodvaccines

142

Development and validation of an ELISA for quantitation of Bovine Viral Diarrhea Virus antigen in the critical stages of vaccine production  

Microsoft Academic Search

Bovine Viral Diarrhea Virus (BVDV) is the causative agent of a worldwide disease. The virus infects bovines of all ages, causing reproductive problems and contaminating biological products of high commercial value. The large-scale production of BVDV vaccines presents the challenge of processing antigenic proteins that are highly susceptible to the processing environment. Potency testing requires the immunization of cattle in

A. Pecora; M. S. Perez Aguirreburualde; D. Rodriguez; C. Seki; M. S. Levy; D. Bochoeyer; M. J. Dus Santos; A. Wigdorovitz

2009-01-01

143

Chemistry and biology of selected natural products  

Microsoft Academic Search

Natural products often offer excitement, stimulation, challenges and op- portunities for chemists, biologists and medical investigators. The study of their chemistry, biology and medicine provides, more often than not, rewards imagined and unimagined, and is still a major frontier in organic chemistry. In this article we summa- rize some of our recent work in this area and project ahead to

K. C. Nicolaou; E. A. Theodorakis; C. F. Claiborne

1996-01-01

144

Calibration of the Ph. Eur. Biological Reference Preparation (BRP) for tetanus vaccine (adsorbed) batch 3.  

PubMed

A joint collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) to establish replacement batches for the European Pharmacopoeia (Ph. Eur.) Tetanus Vaccine (adsorbed) Biological Reference Preparation (BRP) batch 2 and for the WHO 3rd International Standard (IS) for Tetanus toxoid (adsorbed). Two freeze-dried stabilised tetanus vaccine (adsorbed) candidate preparations (Preparation A, 08/218 and Preparation B, 08/102) were calibrated against the current 3rd IS/BRP batch 2 (Preparation C) using challenge methods in guinea pigs and mice as described in the Ph. Eur. general chapter 2.7.8. Assay of tetanus vaccine (adsorbed). They were also assayed by serology methods. The WHO 2nd IS for Tetanus toxoid adsorbed (TEXA-2) was additionally included in the sample panel as Preparation D. Thirty-four laboratories (regulatory organisations and manufacturers) from 22 countries participated in the collaborative study. The majority of participants performed 2 independent challenge tests. Nine laboratories performed challenge assays in guinea pigs and 30 laboratories performed challenge assays in mice. Eight laboratories performed serology in guinea pigs and 1 laboratory performed serology in mice. For Preparation A, the geometric mean (GM) potency estimate (with 95 % confidence interval (CI)) in guinea pigs for all laboratories that provided valid results (n = 6) was 488.5 (354.2-673.6) IU/ampoule. For valid mouse assays (n = 25) the GM potency (with 95 % CI) was 259.8 (223.5-302.0) IU/ampoule. The inter-laboratory geometric coefficient of variation (GCV) was 36 % for guinea pig assays and 45 % for mouse assays. This compared favourably with the calibration of the 3rd IS/BRP batch 2 where the inter-laboratory GCV was 36 % and 42 % in guinea pigs and mice, respectively. For Preparation B, the GM potency estimate (with 95 % CI) in guinea pigs for all laboratories that provided valid results (n = 6) was 107.9 (64.1-181.7) IU/ampoule. For valid mouse assays (n = 24) the GM potency (with 95 % CI) was 147.9 (126.3-173.1) IU/ampoule. The inter-laboratory GCV was 64.3 % for guinea pig assays and 45.2 % for mouse assays. From the collaborative study, Preparation A appeared more suitable to be the replacement Ph. Eur. BRP as it is similar to the Tetanus vaccine (adsorbed) BRP batch 2, except for nature of the stabiliser. Preparation A was confirmed to have higher potency, readily detectable tetanus toxoid, and confirmed satisfactory stability and performance in challenge assays. Preparation A was adopted in January 2011 by the Ph. Eur. Commission as the Tetanus vaccine (adsorbed) BRP batch 3, with assigned potencies of 490 IU/ampoule in the guinea pig challenge assay and of 260 IU/ampoule in the mouse challenge assay. The same Preparation A was adopted in October 2010 as the WHO 4th IS for Tetanus toxoid (adsorbed), with the assigned activity of 490 IU/ampoule from guinea pig challenge assays. A follow-up study (reporting study) was organised by the EDQM to assess the impact of the potency assigned to the BRP batch 3 for mouse challenge assays on the outcome of batch release testing in Europe. Eight laboratories including official medicines control laboratories (OMCLs) and manufacturers reported the results of their routine testing, using the BRP batch 3 in addition to their regular reference preparation. For each tested product, participants calculated the potency relative to their routine reference and relative to the BRP batch 3. No common sample panel was distributed to participants. In total, data on 40 batches of different marketed tetanus vaccines were reported. Overall, a good concordance was observed between the potencies calculated relative to the BRP batch 2 and relative to the BRP batch 3. On average, the potency estimates were 10 % lower when expressed relative to the BRP batch 3. Cases of discrepant decisions for batch release were very limited and affected mainly batches with

Tierney, R; Hockley, J; Rigsby, P; Terao, E; Daas, A; Buchheit, K-H; Sesardic, D

2011-06-01

145

Vaccination of cattle using monovalent modified-live vaccine against bluetongue virus serotype 2: innocuity, immunogenicity and effect on pregnancy  

Microsoft Academic Search

Summary The immunogenicity, innocuity and possible teratogenic effects of the monovalent modified-live vaccine against bluetongue (BT) virus (BTV) serotype 2, manufactured by Onderstepoort Biological Products in South Africa, was evaluated in cows. Twenty-one cows, 14 of which were at different stages of gestation, were vaccinated with 2 ml of monovalent vaccine; two served as unvaccinated controls. After immunisation, 16 vaccinated

F. Monaco; B. Bonfini; M. Zaghini; D. Antonucci; A. Pini; G. Savini

146

Appraisal of rabies vaccine potency by determination of in vitro, specific interleukin-2 production.  

PubMed

The potency of different rabies vaccines was measured via cell mediated immunity (CMI) assessed by the production of interleukin-2 (IL-2) by CD4+CD8- lymphocytes. IL-2 production by splenocytes from mice immunized with various vaccines was measured following in vitro stimulation with antigens from different rabies and rabies-related strains. IL-2 production was specific, reproducible and correlated with the vaccine protective activity as determined by the pre-exposure NIH test. Our results suggest that measurement of IL-2 production could be used for the appraisal of rabies vaccine potency. PMID:1888490

Joffret, M L; Zanetti, C; Morgeaux, S; Leclerc, C; Sureau, P; Perrin, P

1991-04-01

147

Human immune responses to vaccines in the first year of life: biological, socio-economic and ethical issues - a viewpoint.  

PubMed

Human newborns are vulnerable to infectious diseases that account for majority of the morbidity and mortality, particularly in first year of life. Vaccines have become the most effective public health intervention strategy to curtail the prevalence of these infectious diseases. Although vaccines against a number of diseases exist, there are no vaccines against many other diseases that commonly affect children. The adequate assessment of immune responses to vaccines is an important step in the development of vaccines. However, a number of biological and "non-medical" socio-economic and ethical factors could influence either the administration and/or evaluation of vaccines in infants. Recognition and understanding of these determinants are crucial in planning interventions and for logical interpretations of results. PMID:22728219

Ota, M O C; Idoko, O T; Ogundare, E O; Afolabi, M O

2012-06-19

148

Blood Products Advisory Committee  

Center for Biologics Evaluation and Research (CBER)

... Committees & Meeting Materials. Blood, Vaccines and Other Biologics. Blood Products Advisory Committee. ? -. ... Blood Products Advisory Committee. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

149

[Production and implementation of predictive biological models].  

PubMed

The production and implementation of methodologies allowing the construction of coherent, precise and trustworthy predictive biological models has become an inescapable necessity. The financial stakes -attached to this reality are very high indeed, be it in the public or the private domains (health, research, pharma and foodstuffs industries, environment, etc.). Modelling biological systems is widely presented as a problem in computational sciences. While certainly very true for low complexity, practically continuous systems, this view cannot be upheld in the case of discontinuous, hyper-complex systems such as living entities. In these domains, modelling becomes a problem in biology assisted by computational sciences and certainly not the obverse. The following article will attempt to demonstrate why it is so, using concrete examples. PMID:19602358

Iris, François; Gea, Manuel; Lampe, Paul-Henri; Santamaria, Pablo

150

[Molecular biological aspects of animal production].  

PubMed

Molecular biological methods developed for basic research have been increasingly employed in animal production. For example, individual animals can be identified by their unique DNA sequences in DNA fingerprints and their genetic relationships can be established by more detailed sequence comparisons. It is also possible to diagnose gene defects and to determine the sex of preimplantation embryos. This information can then be used as the basis for an efficient breeding program. Methods for the analysis of RNA yield information about genetic or environmental factors which influence the expression of specific genes for example genes of economic value in milk production or genes which are important for preimplantation embryo development. This information will enable further improvements in embryo transfer and associated biotechniques which promise to improve the rate of genetic improvement (NIEMANN and MEINECKE, 1993). In the following section, we will briefly describe these molecular biological methods and their applications in animal breeding using examples from current research in our research group. PMID:9011499

Wrenzycki, C; Carnwath, J W

151

Lipid oxidation: Mechanisms, products and biological significance  

Microsoft Academic Search

This paper reviews our studies of fatty acid hydroperoxides, their secondary products and mechanisms for their formation in\\u000a the context of some of their possible biological consequences. The uneven distribution of isomeric hydroperoxides in oxidized\\u000a linolenate and photosensitized oxidized linoleate is related to the formation of hydroperoxy cyclic peroxides. Interest in\\u000a the hydroperoxy mono-and bi-cycloendoperoxides from oxidized linolenate stems from

E. N. Frankel

1984-01-01

152

Production of adenovirus vectors and their use as a delivery system for influenza vaccines  

PubMed Central

IMPORTANCE OF THE FIELD With the emergence of highly pathogenic avian influenza H5N1 viruses that have crossed species barriers and are responsible for lethal infections in humans in many countries, there is an urgent need for the development of effective vaccines which can be produced in large quantities at a short notice and confer broad protection against these H5N1 variants. In order to meet the potential global vaccine demand in a pandemic scenario, new vaccine-production strategies must be explored in addition to the currently used egg-based technology for seasonal influenza. AREAS COVERED IN THIS REVIEW Adenovirus (Ad) based influenza vaccines represent an attractive alternative/supplement to the currently licensed egg-based influenza vaccines. Ad-based vaccines are relatively inexpensive to manufacture, and their production process does not require either chicken eggs or labor intensive and time-consuming processes necessitating enhanced biosafety facilities. Most importantly, in a pandemic situation, this vaccine strategy could offer a stockpiling option to reduce the response time before a strain-matched vaccine could be developed. WHAT THE READER WILL GAIN This review discusses Ad-vector technology and the current progress in the development of Ad-based influenza vaccines. TAKE HOME MESSAGE Ad vector-based influenza vaccines for pandemic preparedness are under development to meet the global vaccine demand.

Vemula, Sai V.; Mittal, Suresh K.

2010-01-01

153

Factors Affecting U.S. Manufacturers' Decisions To Produce Vaccines Although vaccine makers have concerns about today's high production costs, they are increasing their R&D investment  

Microsoft Academic Search

Recent supply interruptions of childhood vaccines have had negative impacts on U.S. public health policies and vaccine delivery. To understand how manufacturers per- ceive production incentives and disincentives, the Centers for Disease Control and Preven- tion (CDC) met with the four pharmaceutical firms that sold vaccines through CDC-negoti- ated contracts during 2002 and 2003. These meetings shed light on the

Margaret S. Coleman; Nalinee Sangrujee; Fangjun Zhou; Susan Chu

154

Human and animal vaccine contaminations.  

PubMed

Vaccination is one of the most important public health accomplishments. However, since vaccine preparation involves the use of materials of biological origin, vaccines are subject to contamination by micro-organisms. In fact, vaccine contamination has occurred; a historical example of vaccine contamination, for example, can be found in the early days of development of the smallpox vaccine. The introduction of new techniques of vaccine virus production on cell cultures has lead to safer vaccines, but has not completely removed the risk of virus contamination. There are several examples of vaccine contamination, for example, contamination of human vaccines against poliomyelitis by SV40 virus from the use of monkey primary renal cells. Several veterinary vaccines have been contaminated by pestiviruses from foetal calf serum. These incidents have lead industry to change certain practices and regulatory authorities to develop more stringent and detailed requirements. But the increasing number of target species for vaccines, the diversity of the origin of biological materials and the extremely high number of known and unknown viruses and their constant evolution represent a challenge to vaccine producers and regulatory authorities. PMID:20456974

Pastoret, Paul-Pierre

2010-04-24

155

Measurement of final container residual moisture in freeze-dried biological products.  

PubMed

The Center for Biologics Evaluation and Research has changed its regulations pertaining to residual moisture in freeze-dried biological products as published in Title 21 of the Code of Federal Regulations for Food and Drugs. The new regulation requires that each lot of dried product be tested for residual moisture and meet and not exceed established limits as specified by an approved method on file in the product license application. The gravimetric or loss-on-drying method is no longer listed as the required method; the 1.0% moisture limit is no longer specifically stated in the regulation. These revisions were made to bring the regulation into line with changes in residual moisture testing methods and the results obtained when new testing methods were applied to the determination of residual moisture. This is illustrated with data for Measles Virus Vaccine Live and Haemophilus b Polysaccharide Vaccine using final container residual moisture test results obtained by the gravimetric, coulometric Karl Fischer, thermogravimetric and thermogravimetric/mass spectrometric methods. Guidelines for the determination of residual moisture in dried biological products have been issued to describe residual moisture test methods and procedures used to set product residual moisture limits. For most products levels of residual moisture should be low, usually from less than 1.0% to 3.0%, so that the viability, immunologic potency and therefore the stability of the product is not compromised over time. PMID:1592165

May, J C; Wheeler, R M; Etz, N; Del Grosso, A

1992-01-01

156

Vaccines  

Center for Biologics Evaluation and Research (CBER)

... Pandemic Influenza Information; FDA/NIH/WHO Public Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of ... More results from www.fda.gov/biologicsbloodvaccines/vaccines

157

Sustainable coccidiosis control in poultry production: the role of live vaccines.  

PubMed

The development of new methods of administering coccidiosis vaccines has facilitated their use in the hatchery and thereby improved prospects for the economic vaccination of broilers. The acquisition of protective immunity to Eimeria species is boosted by further exposure to infection after vaccination. Factors that affect the reproductive efficiency of non-attenuated and attenuated vaccines are considered and the key role that oocyst production plays in establishing and maintaining uniform immunity in a flock of chickens is discussed. In addition to immunisation, a possible advantage to the application of certain vaccines is that their use could repopulate poultry houses with drug-sensitive organisms. Theoretical rotation programmes in which the use of drugs is alternated with that of vaccines are described. Variability of the cross-protective immune response between strains of the same species should be considered during vaccine development and subsequent use. The significance of less common species of Eimeria, not included in all vaccines, also needs to be assessed. An important consideration is the occurrence of pathogens other than Eimeria (such as the bacterium Clostridium) in flocks given coccidiosis vaccines and the methods by which they might be controlled. More research is required into the relationship between bacterial and viral infections of poultry and coccidiosis vaccination. Vaccines need to be developed that are simple to apply and cost effective for use in areas of the world where small-scale poultry production is commonplace. In the near future it is likely that more live vaccines based upon oocysts derived from attenuated strains of Eimeria will be developed but in the longer term vaccines will be based on the selective presentation to the host of specific molecules that can induce protective immunity. This achievement will require significant investment from the private and public sectors, and, if successful, will facilitate the sustainable control of coccidiosis in poultry production. PMID:11943233

Chapman, H D; Cherry, T E; Danforth, H D; Richards, G; Shirley, M W; Williams, R B

2002-05-01

158

9 CFR 113.3 - Sampling of biological products.  

Code of Federal Regulations, 2013 CFR

...purity, safety, or potency tests. Biological product in final container shall be selected to test for viable bacteria and fungi. (ii) Viable liquid biological products; samples shall be in final containers and shall be randomly selected at the...

2013-01-01

159

Development of a rapid biological assay for determination of potency of Newcastle disease vaccine (strain I-2)  

Microsoft Academic Search

A rapid biological assay based on incubation time has been developed for determination of the potency of Newcastle disease\\u000a virus strain I-2 vaccine. It is based on the observation that the interval between inoculation and the first detection of\\u000a haemagglutinin (HA) depends on the titre of the vaccine inoculated. Chicken embryonated eggs were inoculated with different\\u000a titres (109, 106 and

P. N. Wambura; J. Meers; P. Spradbrow

2006-01-01

160

9 CFR 115.2 - Inspections of biological products.  

Code of Federal Regulations, 2013 CFR

...to have any such veterinary biological product in their possession...importation of any such veterinary biological product. All notifications...s) of any such veterinary biological product at each location in...Management and Budget under control number 0579-0318)...

2013-01-01

161

[Production of biological silage from fish scraps].  

PubMed

Fish waste from the fish processing industry were used as a raw material to produce biological silage. The technology used had been previously developed and tested to optimize the process. The degree of grinding, molasses concentration, process temperature, Lactobacillus plantarum inoculation, and utilization of tropical fruit wastes as a source of proteolytic enzymes were tested. Results indicated that after process and storage for 90 days at room temperature, a stable product is obtained by using no less than 15% of molasses and 10% of fruit waste, process temperature should be around 40 degrees C, the fish have to be ground to a very small particle size, and microbial inoculation is necessary. PMID:8984967

Bello, R; Brito, L

1994-12-01

162

Evaluation of Biological Product Safety Throughout the ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... and anyone else who cares to submit ... In those days, some vaccine manufacturers were dropping out ... insert, letters to health care providers, articles ... More results from www.fda.gov/downloads/biologicsbloodvaccines/internationalactivities

163

Vaccine antigen production in transgenic plants: strategies, gene constructs and perspectives  

Microsoft Academic Search

Stable integration of a gene into the plant nuclear or chloroplast genome can transform higher plants (e.g. tobacco, potato, tomato, banana) into bioreactors for the production of subunit vaccines for oral or parental administration. This can also be achieved by using recombinant plant viruses as transient expression vectors in infected plants. The use of plant-derived vaccines may overcome some of

Francesco Sala; M Manuela Rigano; Alessandra Barbante; Barbara Basso; Amanda M Walmsley; Stefano Castiglione

2003-01-01

164

Biological production of ethanol from coal  

SciTech Connect

Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H[sub 2], CO[sub 2], CH[sub 4] and sulfur gases, is first produced using traditional gasification techniques. The CO, CO[sub 2] and H[sub 2] are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product if the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the wild strain'' produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.

Not Available

1992-12-01

165

Thermal Effects on Schistosoma mansoni Irradiation-Attenuated Vaccine Production and Administration.  

National Technical Information Service (NTIS)

Studies were conducted on variable thermal conditions for Schistosoma mansoni nonirradiated cercarial penetration and worm burdens and for irradiation-attenuated vaccine production and administration. A broad range of temperatures (20-35 C) yielded no sig...

M. Stek S. M. Sulaiman

1984-01-01

166

Transfer of technology for production of rabies vaccine: Memorandum from a WHO Meeting*  

PubMed Central

The important challenge of prevention and control of rabies in the world will require international efforts to increase the availability and use of high quality cell-culture rabies vaccines for use in man and animals. An important aspect of activities to ensure such availability is transfer of technologies to developing countries for production of these vaccines. This article, which is based on the report of a WHO Consultation, outlines the technical options for vaccine production. The principles and economic aspects of technology transfer are considered, and a WHO assistance programme is outlined. It is concluded that technology transfer should be mediated through a framework of national institutes, expert panels, WHO collaborating centres, production and control laboratories, and other relevant institutions. On this basis, recommendations are made concerning the mechanisms of technology transfer for production of cell-culture rabies vaccines.

1985-01-01

167

Three Rs Approaches in the Production and Quality Control of Fish Vaccines.  

PubMed

The workshop on Three Rs Approaches in the Production and Quality Control of Fish Vaccines aimed a) to identify animal tests currently stipulated for the production and quality control of fish vaccines and to highlight animal welfare concerns associated with these tests; b) to identify viable options to replace, reduce, and refine animal use for fish vaccine testing; and c) to discuss the way forward and set out how the Three Rs may be implemented without jeopardizing the quality of the vaccines. The workshop participants - experts from academia, regulatory authorities, a scientific animal welfare organization, and the fish vaccine industry - agreed that efforts should be undertaken to replace the vaccination-challenge batch potency testing with tests based on antigen quantification or antibody response tests. Regulatory requirements of questionable scientific value and relevance for the quality of fish vaccines, such as the re-testing of batches produced outside Europe, or the double-dose batch safety test, should be re-considered. As an immediate measure the design of the current animal tests should be evaluated and modified in the light of refinement and reduction, for example, the number of unprotected control fish in vaccination-challenge tests should be reduced to the minimum. PMID:21371907

Midtlyng, Paul J; Hendriksen, Coenraad; Balks, Elisabeth; Bruckner, Lukas; Elsken, Lawrence; Evensen, Oystein; Fyrand, Kjetil; Guy, Allison; Halder, Marlies; Hawkins, Penny; Kisen, Gunn; Romstad, Anne Berit; Salonius, Kira; Smith, Patrick; Sneddon, Lynne U

2011-03-02

168

Gulf war syndrome: could it be triggered by biological warfare-vaccines using pertussis as an adjuvant?  

Microsoft Academic Search

Several recent epidemiological studies have shown that vaccinations against biological warfare using pertussis as an adjuvant were associated with the Gulf war syndrome. If such epidemiological findings are confirmed, we propose that the use of pertussis as an adjuvant could trigger neurodegeneration through induction of interleukin-1? secretion in the brain. In turn, neuronal lesions may be sustained by stress or

J.-N. Tournier; A. Jouan; J. Mathieu; E. Drouet

2002-01-01

169

February 25, 2011: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... so on, it might be earlier or later in the season before you would know whether a switch had occurred and in Australia, New Zealand, South Africa ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

170

May 8, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... Robert Daum, Chair Dr. Gillian Air Dr. Michael Hudgens * Dr. Pedro Piedra Dr. Ambrose Cheung * Dr. Anna Durbin ** Dr. Gregory Gray * Dr. Gary ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

171

May 7, 2010: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... Gordon Allan, Ph.D. Professor The Queens University Belfast 51 Cabin Hill Gardens Belfast BTS 7AQ Northern Ireland United Kingdom. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

172

May 8, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... make recommendations regarding personnel staffing decisions. ... FDA intends to make background material ... material will be made publicly available ... More results from www.fda.gov/advisorycommittees/calendar

173

April 6-7, 2011: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... 9:45 am, Laboratory of Bacterial Polysaccharides, Willie Vann, Ph.D., FDA. 10:00 am, Q & A, 10:05 am, Break, 10:20 am, Open Public Hearing, ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

174

May 7, 2010: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... The committee discussed available data regarding the unexpected finding of DNA originating from porcine circovirus type 1 (PCV 1) in Rotarix, a ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

175

May 7, 2010: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... disease in pigs nor other animals, including humans. ... other mammalian cells, including human cell lines ... need for any additional experiments or data ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

176

Meeting of The Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... before, but obviously many things have changed since I was here last, although many of the faces are recycles also. With that ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

177

September 9, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... an outside neurologist” 3. Page 20, Table 14, delete the words, “and seronegative” from the table title 4. Page 20, Table ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

178

May 8, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... 02/01/2012 – 01/31/2016 Professor of Pediatrics Microbiology and Molecular Medicine Director, The University of Chicago MRSA Research Center ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

179

May 7, 2010: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... particle, so all internal investigation indicated that we can detect for each test an equivalent of one to ten TCID50 of infective PCV1 viral particles. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

180

September 9, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... 35 The two most frequently reported NOADs were hypothyroidism, with three subjects in the HPV/[15-25] age group (0.1%) ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

181

Notice of Meeting Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. ... More results from www.fda.gov/downloads/advisorycommittees/calendar

182

Roster of the Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... Virology/Infectious Diseases Term: 06/07/2010 – 01/31/2014 Associate Professor Johns Hopkins Bloomberg School of Public Health Center for ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

183

February 27, 2013: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... 9:15, World Surveillance/Virus Characterization, Nancy Cox, Ph.D. Director, Influenza Division Director, WHO Collaborating Center For Surveillance ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

184

July 23, 2009: Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Iowa. DR. LEVANDOWSKI: Roland Levandowski. ... for being as on top of things as you obviously are. Second, a comment back to Roland about the ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

185

Charter of the Vaccines and Related Biological Products ...  

Center for Biologics Evaluation and Research (CBER)

... for which the Food and Drug Administration has ... advice to the Commissioner of Food and Drugs. ... and HHS General Administration Manual directives ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics

186

Monascus secondary metabolites: production and biological activity.  

PubMed

The genus Monascus, comprising nine species, can reproduce either vegetatively with filaments and conidia or sexually by the formation of ascospores. The most well-known species of genus Monascus, namely, M. purpureus, M. ruber and M. pilosus, are often used for rice fermentation to produce red yeast rice, a special product used either for food coloring or as a food supplement with positive effects on human health. The colored appearance (red, orange or yellow) of Monascus-fermented substrates is produced by a mixture of oligoketide pigments that are synthesized by a combination of polyketide and fatty acid synthases. The major pigments consist of pairs of yellow (ankaflavin and monascin), orange (rubropunctatin and monascorubrin) and red (rubropunctamine and monascorubramine) compounds; however, more than 20 other colored products have recently been isolated from fermented rice or culture media. In addition to pigments, a group of monacolin substances and the mycotoxin citrinin can be produced by Monascus. Various non-specific biological activities (antimicrobial, antitumor, immunomodulative and others) of these pigmented compounds are, at least partly, ascribed to their reaction with amino group-containing compounds, i.e. amino acids, proteins or nucleic acids. Monacolins, in the form of ?-hydroxy acids, inhibit hydroxymethylglutaryl-coenzyme A reductase, a key enzyme in cholesterol biosynthesis in animals and humans. PMID:23179468

Patakova, Petra

2012-11-20

187

OIE standards for vaccines and future trends.  

PubMed

The World Organisation for Animal Health (OIE), sets out international standards for vaccines in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (mammals, birds and bees). The texts are drafted by experts then sent for scientific peer review and for comment by all OIE Member Countries, thus achieving a consensus at the point of adoption. Introductory chapters in the Terrestrial Manual provide general principles of laboratory management and vaccine production, and disease-specific chapters provide detailed standards for vaccines for the OIE listed diseases. Issues that the OIE Biological Standards Commission are currently addressing or will address in the near future include the matching of vaccine strains to currently circulating infectious agents, the use of companion diagnostic tests to differentiate infected from vaccinated animals, the development of vaccine banks, and the application of DNA technology to vaccine design and production. PMID:17892158

Edwards, S

2007-08-01

188

Immunization against Genital Herpes with a Vaccine Virus That has Defects in Productive and Latent Infection  

NASA Astrophysics Data System (ADS)

An effective vaccine for genital herpes has been difficult to achieve because of the limited efficacy of subunit vaccines and the safety concerns about live viruses. As an alternative approach, mutant herpes simplex virus strains that are replication-defective can induce protective immunity. To increase the level of safety and to prove that replication was not needed for immunization, we constructed a mutant herpes simplex virus 2 strain containing two deletion mutations, each of which eliminated viral replication. The double-mutant virus induces protective immunity that can reduce acute viral shedding and latent infection in a mouse genital model, but importantly, the double-mutant virus shows a phenotypic defect in latent infection. This herpes vaccine strain, which is immunogenic but has defects in both productive and latent infection, provides a paradigm for the design of vaccines and vaccine vectors for other sexually transmitted diseases, such as AIDS.

da Costa, Xavier J.; Jones, Cheryl A.; Knipe, David M.

1999-06-01

189

IRRIGATION TO MAXIMIZE VACCINE ANTIGEN PRODUCTION IN PHARMACEUTICAL TOBACCO  

Technology Transfer Automated Retrieval System (TEKTRAN)

Biotechnology companies have engineered plants to produce recombinant proteins for therapeutic drugs and vaccines. Chlorogen, Inc. located in St. Louis, Missouri, inserted the protective antigen (PA) gene from Bacillus anthracis into tobacco (Nicotiana tabacum) chloroplasts to produce an anthrax va...

190

Development and validation of an ELISA for quantitation of bovine viral diarrhea virus antigen in the critical stages of vaccine production.  

PubMed

Bovine Viral Diarrhea Virus (BVDV) is the causative agent of a worldwide disease. The virus infects bovines of all ages, causing reproductive problems and contaminating biological products of high commercial value. The large-scale production of BVDV vaccines presents the challenge of processing antigenic proteins that are highly susceptible to the processing environment. Potency testing requires the immunization of cattle in order to determine the neutralizing antibodies titers induced by the vaccine. An alternative to the in vivo test is an in vitro measurement of key viral antigens. This paper describes the development and validation of a sandwich-type indirect ELISA that is able to detect and quantify BVDV E2 glycoprotein in live and inactivated BVDV. Validation parameters such as repeatability, intermediate precision, and reproducibility indicated that the developed ELISA constitutes an advanced tool for evaluating the BVDV antigen throughout manufacturing and vaccine release testing. PMID:19665482

Pecora, A; Perez Aguirreburualde, M S; Rodriguez, D; Seki, C; Levy, M S; Bochoeyer, D; Dus Santos, M J; Wigdorovitz, A

2009-08-07

191

[Progress in research on molecular biology and application in dominant antigens ESAT6 and CFP10 of TB vaccine].  

PubMed

As the dominant antigens, early secreted antigenic target 6 (ESAT6, E6) and culture filtrate protein 10 (CFP10, C10) had once been the focus of tuberculosis (TB) vaccine due to their capability of inducing strong cell immune response in the host. They are also endowed with promising future of prevention against and diagnosis of TB. In this review, we systematically introduce recent research progress of E6 and C10, especially in structure-function, biological characteristics, protein expression and secretion, host immunity and vaccine development, and the prospects of their application are also discussed. PMID:22616197

Fan, Qin; Bao, Lang

2012-04-01

192

Production of recombinant subunit vaccines: protein immunogens, live delivery systems and nucleic acid vaccines  

Microsoft Academic Search

The first scientific attempts to control an infectious disease can be attributed to Edward Jenner, who, in 1796 inoculated an 8-year-old boy with cowpox (vaccinia), giving the boy protection against subsequent challenge with virulent smallpox. Thanks to the successful development of vaccines, many major diseases, such as diphtheria, poliomyelitis and measles, are nowadays kept under control, and in the case

Sissela Liljeqvist; Stefan Ståhl

1999-01-01

193

Biological hydrogen production using a membrane bioreactor.  

PubMed

A cross-flow membrane was coupled to a chemostat to create an anaerobic membrane bioreactor (MBR) for biological hydrogen production. The reactor was fed glucose (10,000 mg/L) and inoculated with a soil inoculum heat-treated to kill non-spore-forming methanogens. Hydrogen gas was consistently produced at a concentration of 57-60% in the headspace under all conditions. When operated in chemostat mode (no flow through the membrane) at a hydraulic retention time (HRT) of 3.3 h, 90% of the glucose was removed, producing 2200 mg/L of cells and 500 mL/h of biogas. When operated in MBR mode, the solids retention time (SRT) was increased to SRT = 12 h producing a solids concentration in the reactor of 5800 mg/L. This SRT increased the overall glucose utilization (98%), the biogas production rate (640 mL/h), and the conversion efficiency of glucose-to-hydrogen from 22% (no MBR) to 25% (based on a maximum of 4 mol-H(2)/mol-glucose). When the SRT was increased from 5 h to 48 h, glucose utilization (99%) and biomass concentrations (8,800 +/- 600 mg/L) both increased. However, the biogas production decreased (310 +/- 40 mL/h) and the glucose-to-hydrogen conversion efficiency decreased from 37 +/- 4% to 18 +/- 3%. Sustained permeate flows through the membrane were in the range of 57 to 60 L/m(2) h for three different membrane pore sizes (0.3, 0.5, and 0.8 microm). Most (93.7% to 99.3%) of the membrane resistance was due to internal fouling and the reversible cake resistance, and not the membrane itself. Regular backpulsing was essential for maintaining permeate flux through the membrane. Analysis of DNA sequences using ribosomal intergenic spacer analysis indicated bacteria were most closely related to members of Clostridiaceae and Flexibacteraceae, including Clostridium acidisoli CAC237756 (97%), Linmingia china AF481148 (97%), and Cytophaga sp. MDA2507 AF238333 (99%). No PCR amplification of 16s rRNA genes was obtained when archaea-specific primers were used. PMID:15211496

Oh, Sang-Eun; Iyer, Prabha; Bruns, Mary Ann; Logan, Bruce E

2004-07-01

194

Biology and technology for photochemical fuel production.  

PubMed

Sunlight is the ultimate energy source for the vast majority of life on Earth, and organisms have evolved elegant machinery for energy capture and utilization. Solar energy, whether converted to wind, rain, biomass or fossil fuels, is also the primary energy source for human-engineered energy transduction systems. This tutorial review draws parallels between biological and technological energy systems. Aspects of biology that might be advantageously incorporated into emerging technologies are highlighted, as well as ways in which technology might improve upon the principles found in biological systems. Emphasis is placed upon artificial photosynthesis, as well as the use of protonmotive force in biology. PMID:19088962

Hambourger, Michael; Moore, Gary F; Kramer, David M; Gust, Devens; Moore, Ana L; Moore, Thomas A

2008-11-04

195

Influenza vaccine production for Brazil: a classic example of successful North-South bilateral technology transfer.  

PubMed

Technology transfer is a promising approach to increase vaccine production at an affordable price in developing countries. In the case of influenza, it is imperative that developing countries acquire the technology to produce pandemic vaccines through the transfer of know-how, as this will be the only way for the majority of these countries to face the huge demand for vaccine created by influenza pandemics. Access to domestically produced influenza vaccine in such health crises is thus an important national defence strategy. However, technology transfer is not a simple undertaking. It requires a committed provider who is willing to transfer a complete production process, and not just the formulation and fill-finish parts of the process. It requires a recipient with established experience in vaccine production for human use and the ability to conduct research into new developments. In addition, the country of the recipient should preferably have sufficient financial resources to support the undertaking, and an internal market for the new vaccine. Technology transfer should create a solid partnership that results in the joint development of new competency, improvements to the product, and to further innovation. The Instituto Butantan-sanofi pasteur partnership can be seen as a model for successful technology transfer and has led to the technological independence of the Instituto Butantan in the use a strategic public health tool. PMID:21684420

Miyaki, Cosue; Meros, Mauricio; Precioso, Alexander R; Raw, Isaias

2011-07-01

196

Vaccine antigen production in transgenic plants: strategies, gene constructs and perspectives.  

PubMed

Stable integration of a gene into the plant nuclear or chloroplast genome can transform higher plants (e.g. tobacco, potato, tomato, banana) into bioreactors for the production of subunit vaccines for oral or parental administration. This can also be achieved by using recombinant plant viruses as transient expression vectors in infected plants. The use of plant-derived vaccines may overcome some of the major problems encountered with traditional vaccination against infectious diseases, autoimmune diseases and tumours. They also offer a convenient tool against the threat of bio-terrorism. State of the art, experimental strategies, safety and perspectives are discussed in this article. PMID:12531364

Sala, Francesco; Manuela Rigano, M; Barbante, Alessandra; Basso, Barbara; Walmsley, Amanda M; Castiglione, Stefano

2003-01-30

197

9 CFR 112.6 - Packaging biological products.  

Code of Federal Regulations, 2013 CFR

...PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING § 112.6 Packaging biological products. (a) Each multiple-dose final...

2013-01-01

198

Reaching international GMP standards for vaccine production: challenges for developing countries.  

PubMed

Standards for vaccine production have been increasing at a rapid rate. Current standards of good manufacturing practice (GMP) had been thought to be out of the reach of developing country vaccine producers, many of whom are in the public sector, overseen by unvalidated national regulatory authorities (NRAs). With the advent of the GMP regulations in 1963 and their application to vaccine production, even many industrialized country manufacturers with stringent NRA oversight had difficulties. This article assesses the ability of developing country manufacturers to meet GMP by the only currently available global indicator: WHO prequalification. As recently as 1996, no developing country NRA was considered able to enforce GMP compliance. That number increased to four in 2002 and six in 2006, with a concomitant increase in the number of manufacturers considered to be operating to GMP standards. Examples of the difficulties faced by manufacturers in achieving this are given, as well as implications for the future vaccine market. PMID:19397413

Milstien, Julie; Costa, Alejandro; Jadhav, Suresh; Dhere, Rajeev

2009-05-01

199

Sweeten PAMPs: Role of Sugar Complexed PAMPs in Innate Immunity and Vaccine Biology  

PubMed Central

Innate sensors play a critical role in the early innate immune responses to invading pathogens through sensing of diverse biochemical signatures also known as pathogen associated molecular patterns (PAMPs). These biochemical signatures primarily consist of a major family of biomolecules such as proteins, lipids, nitrogen bases, and sugar and its complexes, which are distinct from host molecules and exclusively expressed in pathogens and essential to their survival. The family of sensors known as pattern recognition receptors (PRRs) are germ-line encoded, evolutionarily conserved molecules, and consist of Toll-like receptors (TLRs), RIG-I-like receptors (RLRs), NOD-like receptors (NLRs), C-type lectin-like receptors (CLRs), and DNA sensors. Sensing of PAMP by PRR initiates the cascade of signaling leading to the activation of transcription factors, such as NF-?B and interferon regulatory factors (IRFs), resulting in a variety of cellular responses, including the production of interferons (IFNs) and pro-inflammatory cytokines. In this review, we discuss sensing of different types of glycosylated PAMPs such as ?-glucan (a polymeric sugar) or lipopolysaccharides, nucleic acid, and so on (sugar complex PAMPs) by different families of sensors, its role in pathogenesis, and its application in development of potential vaccine and vaccine adjuvants.

Mahla, Ranjeet Singh; Reddy, Madhava C.; Prasad, D. Vijaya Raghava; Kumar, Himanshu

2013-01-01

200

BIOLOGICAL CONTROL OF STORED PRODUCT PESTS  

Technology Transfer Automated Retrieval System (TEKTRAN)

This book chapter provides a review of biological control agents used to suppress insect pests of stored grain and food processing facilities. Biological control has several advantages compared to chemical insecticides. Natural enemies leave no harmful chemical residues; and after release in a stora...

201

Biological control and sustainable food production  

Microsoft Academic Search

The use of biological control for the management of pest insects pre-dates the modern pesticide era. The first major successes in biological control occurred with exotic pests controlled by natural enemy species collected from the country or area of origin of the pest (classical control). Augmentative control has been successfully applied against a range of open-field and greenhouse pests, and

J. S. Bale; Lenteren van J. C; F. Bigler

2008-01-01

202

H1N1 vaccines in a large observational cohort of patients with inflammatory bowel disease treated with immunomodulators and biological therapy  

Microsoft Academic Search

BackgroundSafety data are lacking on influenza vaccination in general and on A (H1N1)v vaccination in particular in patients with inflammatory bowel disease (IBD) receiving immmunomodulators and\\/or biological therapy.Aims and methodsThe authors conducted a multicentre observational cohort study to evaluate symptoms associated with influenza H1N1 adjuvanted (Pandemrix, Focetria, FluvalP) and non-adjuvanted (Celvapan) vaccines and to assess the risk of flare of

Jean-François Rahier; Pavol Papay; Julia Salleron; Shaji Sebastian; Manuela Marzo; Laurent Peyrin-Biroulet; Valle Garcia-Sanchez; Walter Fries; Dirk P van Asseldonk; Klaudia Farkas; Nanne K de Boer; Taina Sipponen; Pierre Ellul; Edouard Louis; Simon T C Peake; Uri Kopylov; Jochen Maul; Badira Makhoul; Gionata Fiorino; Yazdan Yazdanpanah; Maria Chaparro

2011-01-01

203

Effect of influenza vaccination on oxidative stress products in breath.  

PubMed

Viral infections cause increased oxidative stress, so a breath test for oxidative stress biomarkers (alkanes and alkane derivatives) might provide a new tool for early diagnosis. We studied 33 normal healthy human subjects receiving scheduled treatment with live attenuated influenza vaccine (LAIV). Each subject was his or her own control, since they were studied on day 0 prior to vaccination, and then on days 2, 7 and 14 following vaccination. Breath volatile organic compounds (VOCs) were collected with a breath collection apparatus, then analyzed by automated thermal desorption with gas chromatography and mass spectroscopy. A Monte Carlo simulation technique identified non-random VOC biomarkers of infection based on their C-statistic values (area under curve of receiver operating characteristic). Treatment with LAIV was followed by non-random changes in the abundance of breath VOCs. 2, 8-Dimethyl-undecane and other alkane derivatives were observed on all days. Conservative multivariate models identified vaccinated subjects on day 2 (C-statistic = 0.82, sensitivity = 63.6% and specificity = 88.5%); day 7 (C-statistic = 0.94, sensitivity = 88.5% and specificity = 92.3%); and day 14 (C-statistic = 0.95, sensitivity = 92.3% and specificity = 92.3%). The altered breath VOCs were not detected in live attenuated influenza vaccine, excluding artifactual contamination. LAIV vaccination in healthy humans elicited a prompt and sustained increase in breath biomarkers of oxidative stress. A breath test for these VOCs could potentially identify humans who are acutely infected with influenza, but who have not yet developed clinical symptoms or signs of disease. PMID:21383469

Phillips, Michael; Cataneo, Renee N; Chaturvedi, Anirudh; Danaher, Patrick J; Devadiga, Anantrai; Legendre, David A; Nail, Kim L; Schmitt, Peter; Wai, James

2010-01-22

204

Biological and phylogenetic characterization of a genotype VII Newcastle disease virus from Venezuela: efficacy of field vaccination.  

PubMed

Here we report the biological and molecular characterization of a virulent genotype VII Newcastle disease virus (NDV) circulating in Venezuela and the assessment of the vaccination efficacy under field conditions compared to controlled rearing conditions. Biological pathotyping showed a mean embryo dead time of 50 h and an intracerebral pathogenicity index of 1.86. Sequence-based phylogenetic analysis demonstrated that the virus belongs to genotype VII in class II (a genotype often found in Asia and Africa), representing the first report of the presence of this genotype in the continent of South America. A vaccine-challenge trial in commercial broilers reared in fields or in a experimental setting included dual (live/killed) priming of 1-day-old chicks plus two live NDV and infectious bursal disease virus (IBDV) field vaccinations at days 7 and 17, followed by a very stringent genotype VII NDV challenge at day 28. Serology for NDV and IBDV, bursal integrity, and protection against NDV lethal challenge were assessed. At 28 days, field vaccinates showed significantly lower NDV (1,356 versus 2,384) and higher IBD (7,295 versus 1,489) enzyme-linked immunosorbent assay (ELISA) antibody titers than the experimentally reared birds. A lower bursal size and bursa-body weight ratio (P < 0.05) and higher bursa lesion score were also detected in the field set. Only 57.1% of field vaccinates survived the lethal challenge, differing (P < 0.05) from 90.5% survival in the experimental farm. Overall, results confirmed the presence of the genotype VII viruses in South America and suggest that field-associated factors such as immunosuppression compromise the efficacy of the vaccination protocols implemented. PMID:22238433

Perozo, Francisco; Marcano, Rosmar; Afonso, Claudio L

2012-01-11

205

Biological and Phylogenetic Characterization of a Genotype VII Newcastle Disease Virus from Venezuela: Efficacy of Field Vaccination  

PubMed Central

Here we report the biological and molecular characterization of a virulent genotype VII Newcastle disease virus (NDV) circulating in Venezuela and the assessment of the vaccination efficacy under field conditions compared to controlled rearing conditions. Biological pathotyping showed a mean embryo dead time of 50 h and an intracerebral pathogenicity index of 1.86. Sequence-based phylogenetic analysis demonstrated that the virus belongs to genotype VII in class II (a genotype often found in Asia and Africa), representing the first report of the presence of this genotype in the continent of South America. A vaccine-challenge trial in commercial broilers reared in fields or in a experimental setting included dual (live/killed) priming of 1-day-old chicks plus two live NDV and infectious bursal disease virus (IBDV) field vaccinations at days 7 and 17, followed by a very stringent genotype VII NDV challenge at day 28. Serology for NDV and IBDV, bursal integrity, and protection against NDV lethal challenge were assessed. At 28 days, field vaccinates showed significantly lower NDV (1,356 versus 2,384) and higher IBD (7,295 versus 1,489) enzyme-linked immunosorbent assay (ELISA) antibody titers than the experimentally reared birds. A lower bursal size and bursa-body weight ratio (P < 0.05) and higher bursa lesion score were also detected in the field set. Only 57.1% of field vaccinates survived the lethal challenge, differing (P < 0.05) from 90.5% survival in the experimental farm. Overall, results confirmed the presence of the genotype VII viruses in South America and suggest that field-associated factors such as immunosuppression compromise the efficacy of the vaccination protocols implemented.

Perozo, Francisco; Marcano, Rosmar

2012-01-01

206

Mass production and standardization of Clostridium oedematiens vaccine against black disease (infectious necrotic hepatitis) of sheep.  

PubMed

The object of this study was to prepare a potent vaccine against black disease of sheep. Attempts were made to prepare and formulate the ingredients in order to obtain high yield of toxin. A 600 litre batch of mass production of Clostridium oedematiens (Cl. novyi) vaccine was prepared with ingredients consisting of 4% peptone, 0.25% NaCl, 0.5% liver extract, 0.1% L-cysteine, 1% maltose, 0.02% sodium dithionite and 0.25% ferrous sulphate solution. The prepared vaccine was diluted to concentrations of 20, 40, 60 and 80 per cent of antigens. Potassium alum was added as an adjuvant. The potency test of the prepared vaccine was determined in a group of forty rabbits according to the British Pharmacopoeia (Veterinary). Maximum titre was obtained at 80 per cent with the level of 33 units per ml of alpha antitoxin in rabbits pooled serum. 20, 16 and 8 units per ml of alpha antitoxin were obtained respectively for 60, 40 and 20 per cent of diluted antigen in rabbits pooled serum. Sheep have been vaccinated in black disease areas with this vaccine. Reports obtained from the field indicate that black disease in sheep could be effectively controlled by this vaccine in Iran. PMID:3792643

Ardehali, M; Darakhshan, H; Moosawi, M

1986-01-01

207

Biological control and sustainable food production.  

PubMed

The use of biological control for the management of pest insects pre-dates the modern pesticide era. The first major successes in biological control occurred with exotic pests controlled by natural enemy species collected from the country or area of origin of the pest (classical control). Augmentative control has been successfully applied against a range of open-field and greenhouse pests, and conservation biological control schemes have been developed with indigenous predators and parasitoids. The cost-benefit ratio for classical biological control is highly favourable (1:250) and for augmentative control is similar to that of insecticides (1:2-1:5), with much lower development costs. Over the past 120 years, more than 5000 introductions of approximately 2000 non-native control agents have been made against arthropod pests in 196 countries or islands with remarkably few environmental problems. Biological control is a key component of a 'systems approach' to integrated pest management, to counteract insecticide-resistant pests, withdrawal of chemicals and minimize the usage of pesticides. Current studies indicate that genetically modified insect-resistant Bt crops may have no adverse effects on the activity or function of predators or parasitoids used in biological control. The introduction of rational approaches for the environmental risk assessment of non-native control agents is an essential step in the wider application of biological control, but future success is strongly dependent on a greater level of investment in research and development by governments and related organizations that are committed to a reduced reliance on chemical control. PMID:17827110

Bale, J S; van Lenteren, J C; Bigler, F

2008-02-27

208

21 CFR 600.14 - Reporting of biological product deviations by licensed manufacturers.  

Code of Federal Regulations, 2010 CFR

...14 Reporting of biological product deviations...manufacturer who holds the biological product license and who had control over the product...should report a biological product deviation...step under your control, acquire...

2009-04-01

209

21 CFR 600.14 - Reporting of biological product deviations by licensed manufacturers.  

Code of Federal Regulations, 2010 CFR

...14 Reporting of biological product deviations...manufacturer who holds the biological product license and who had control over the product...should report a biological product deviation...step under your control, acquire...

2010-04-01

210

General Instructions for Completing the Biological Product ...  

Center for Biologics Evaluation and Research (CBER)

... Disposition - provide the disposition of the product using the following list - DO NOT list any products that were not distributed. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/reportaproblem

211

Iraqi Mobile Biological Warfare Agent Production Plants.  

National Technical Information Service (NTIS)

Coalition forces have uncovered the strongest evidence to date that Iraq was hiding a biological warfare program. Kurdish forces in late April 2003 took into custody a specialized tractor-trailer near Mosul and subsequently turned it over to US military c...

2003-01-01

212

FDA/CBER - Ixiaro Product Approval Information  

Center for Biologics Evaluation and Research (CBER)

Text Version... The biological product: ... countries, because the vast majority of older children will already have been vaccinated or exposed to natural infection. ... More results from www.fda.gov/downloads/biologicsbloodvaccines/vaccines

213

Biological productivity of renewable resources used as industrial materials  

Microsoft Academic Search

The report estimates the biological productivity of industrial renewable resources in terms of current yields, existing land bases, and increments to these bases that may reasonably be forecast by 1985 and 2000. The forecast divides naturally into two parts: the silvicultural product of wood, and products for industry from agriculture consisting chiefly of vegetable fibers, oil seeds, wool, animal fats,

1976-01-01

214

9 CFR 113.50 - Ingredients of biological products.  

Code of Federal Regulations, 2013 CFR

...ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.50 Ingredients of biological...

2013-01-01

215

Impact of Severe Weather Conditions on Biological Products  

Center for Biologics Evaluation and Research (CBER)

... with information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/productsecurity

216

Biological Productivity of Renewable Resources Used as Industrial Materials.  

National Technical Information Service (NTIS)

The report estimates the biological productivity of industrial renewable resources in terms of current yields, existing land bases, and increments to these bases that may reasonably be forecast by 1985 and 2000. The forecast divides naturally into two par...

J. S. Bethel

1976-01-01

217

Bibliography on Photodynamic Action as Related to Biological Products.  

National Technical Information Service (NTIS)

A bibliography on photodynamic action as related to biological products has been prepared. Specific concept guidelines were followed in the gathering of references. Each reference is followed by an unedited author abstract, or summary. Since only one-half...

1966-01-01

218

Biological and Synthetic Systems for Production of Hydrogen from Water.  

National Technical Information Service (NTIS)

Two systems were developed for the production of hydrogen and oxygen by the biophotolysis of water. The first system uses intact hydrogenase-containing algae which do not require isolated biological systems or enzymes. The second system consists of isolat...

A. I. Krasna

1978-01-01

219

A launch vector for the production of vaccine antigens in plants.  

PubMed

Historically, most vaccines have been based on killed or live-attenuated infectious agents. Although very successful at immunizing populations against disease, both approaches raise safety concerns and often have limited production capacity. This has resulted in increased emphasis on the development of subunit vaccines. Several recombinant systems have been considered for subunit vaccine manufacture, including plants, which offer advantages both in cost and in scale of production. We have developed a plant expression system utilizing a 'launch vector', which combines the advantageous features of standard agrobacterial binary plasmids and plant viral vectors, to achieve high-level target antigen expression in plants. As an additional feature, to aid in target expression, stability and purification, we have engineered a thermostable carrier molecule to which antigens are fused. We have applied this launch vector/carrier system to engineer and express target antigens from various pathogens, including, influenza A/Vietnam/04 (H5N1) virus. PMID:19453476

Musiychuk, Konstantin; Stephenson, Natalie; Bi, Hong; Farrance, Christine E; Orozovic, Goran; Brodelius, Maria; Brodelius, Peter; Horsey, April; Ugulava, Natalia; Shamloul, Abdel-Moneim; Mett, Vadim; Rabindran, Shailaja; Streatfield, Stephen J; Yusibov, Vidadi

2007-01-01

220

Biological treatment of chicken feather waste for improved biogas production  

Microsoft Academic Search

A two-stage system was developed which combines the biological degradation of keratin-rich waste with the production of biogas. Chicken feather waste was treated biologically with a recombinant Bacillus megaterium strain showing keratinase activity prior to biogas production. Chopped, autoclaved chicken feathers (4%, W\\/V) were completely degraded, resulting in a yellowish fermentation broth with a level of 0.51 mg\\/mL soluble proteins

Gergely Forgács; Saeid Alinezhad; Amir Mirabdollah; Elisabeth Feuk-Lagerstedt; Ilona Sárvári Horváth

2011-01-01

221

The use of smallpox virus as a biological weapon: the vaccination situation in France.  

PubMed

In the context of its plan to fight against bioterrorism, the Ministry of Health asked the Institut de Veille Sanitaire to evaluate the epidemic risk from a release of the small pox virus, and to make recommendations on potential vaccination strategies to be implemented. A benefit/risk assessment of various vaccination scenarios, including vaccination of the whole French population, was carried out to evaluate the severity of a terrorist action threat. This analysis concludes that at this stage, vaccination action does not seem to be justified. Even in the case of a real threat, the vaccination of frontline healthcare personnel, and in particular of contacts of cases, must be given priority. PMID:11891388

Lévy-Bruhl, D; Guérin, N

2001-11-01

222

What drives the biological productivity of the northern Indian Ocean?  

NASA Astrophysics Data System (ADS)

The northern Indian Ocean consists of two unique tropical basins: the Arabian Sea and the Bay of Bengal. The Arabian Sea is one of the most highly productive regions of the world ocean, while the Bay of Bengal is a basin of low productivity. In this chapter we summarize the biological productivity of these two basins and explore the reasons for this dissimilarity in light of the prevailing atmospheric forcing and associated oceanic processes based on in situ and remote sensing data. The high biological productivity of the Arabian Sea was driven by seasonally changing physical processes in accordance with the semiannual switching of atmospheric forcing. In summer the high biological productivity was triggered by a combination of wind-driven mixing, Ekman pumping associated with the cyclonic wind stress curl, and advection of nutrient-rich waters from the upwelling regions off Somalia and Arabia into the central Arabian Sea, whereas the winter blooms were triggered by winter convection and nutrient injection into the euphotic zone. In contrast, the biological productivity of the Bay of Bengal, situated in a similar latitude and subjected to similar wind forcing, was regulated by a set of different mechanisms. The large freshwater influx during summer inhibits the upward transport of nutrients to the euphotic zone by wind mixing thereby curtailing the biological productivity. The mesoscale eddies, which are ubiquitous in the Bay of Bengal, controlled the bulk of the observed biological productivity. In addition, the tropical cyclones occurring during spring and fall intermonsoons also trigger high biological productivity over short periods.

Prasanna Kumar, S.; Narvekar, Jayu; Nuncio, M.; Gauns, M.; Sardesai, S.

223

Biological production of ethanol from coal  

SciTech Connect

Previous results have shown that the medium pH, the composition of the medium and concentration of medium constituents significantly affect the ratio of ethanol to acetate in the product stream when fermenting CO, CO{sub 2} and H{sub 2} in synthesis gas to products by Clostridium ljungdahlii. An additional batch study was carried out varying the agitation rate at pH 4, 4.5 and 5.0. It was speculated that increased agitation rates in combination with low pH might result in increased ethanol production while, at the same time, yielding higher cell concentrations which could eventually result in higher ethanol concentrations.

Not Available

1990-01-01

224

Biological production of ethanol from coal  

SciTech Connect

A batch kinetic study involving Clostridium lungdahlii in a mineral medium was carried out in order to provide baseline data for the effects of nutrients on product ratio and kinetics. The use of this minimal medium containing vitamins, minerals, select amino acids and salts showed both a lower maximum specific growth rate and a lower maximum specific uptake rate than found when using a complex medium supplemented with 0.01% yeast extract. At the same time, the product ratio was improved slightly in favor of ethanol over acetate. Future experiments will measure the effects of ammonia and phosphate limitation on product ratio and process kinetics.

Not Available

1990-01-01

225

Guidance for Industry: Biological Product Deviation Reporting ...  

Center for Biologics Evaluation and Research (CBER)

... safety only and did not have the potential to affect the safety, purity, or ... service issued a product from the laboratory to the nursing floor, operating ... More results from www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances

226

Biological production of ethanol fom coal  

SciTech Connect

Research is continuing in an attempt to increase both the ethanol concentration and product ratio using C. ljungdahlii. The purpose of this report is to present data (acetate to ethanol) utilizing a medium prepared especially for C. ljungdahlii. Medium development studies are presented, as well as reactor studies with the new medium in batch reactors. Continuous stirred tank reactor (CSTR) with cell recycle. The use of this new medium has resulted in significant improvements in cell concentration, ethanol concentration and product ratio.

Not Available

1992-05-01

227

Biological production of ethanol from coal  

SciTech Connect

Research is continuing in an attempt to increase both the ethanol concentration and product ratio using C. ljungdahlii. The purpose of this report is to present data utilizing a medium prepared especially for C. ljungdahlii. Medium development studies are presented, as well as reactor studies with the new medium in batch reactors. CSTRs and CSTRs with cell recycle. The use of this new medium has resulted in significant improvements in cell concentration, ethanol concentration and product ratio.

Not Available

1992-01-01

228

9 CFR 113.29 - Determination of moisture content in desiccated biological products.  

Code of Federal Regulations, 2013 CFR

...moisture content in desiccated biological products. Methods provided...moisture content in desiccated biological products is prescribed...moisture content in desiccated biological products have until November...original sealed vial. Sample and control should be kept at room...

2013-01-01

229

Production of avian influenza virus vaccine using primary cell cultures generated from host organs.  

PubMed

The global availability of a therapeutically effective influenza virus vaccine during a pandemic remains a major challenge for the biopharmaceutical industry. Long production time, coupled with decreased supply of embryonated chicken eggs (ECE), significantly affects the conventional vaccine production. Transformed cell lines have attained regulatory approvals for vaccine production. Based on the fact that the avian influenza virus would infect the cells derived from its natural host, the viral growth characteristics were studied on chicken embryo-derived primary cell cultures. The viral propagation was determined on avian origin primary cell cultures, transformed mammalian cell lines, and in ECE. A comparison was made between these systems by utilizing various cell culture-based assays. In-vitro substrate susceptibility and viral infection characteristics were evaluated by performing hemagglutination assay (HA), 50 % tissue culture infectious dose (TCID??) and monitoring of cytopathic effects (CPE) caused by the virus. The primary cell culture developed from chicken embryos showed stable growth characteristics with no contamination. HA, TCID??, and CPE exhibited that these cell systems were permissive to viral infection, yielding 2-10 times higher viral titer as compared to mammalian cell lines. Though the viral output from the ECE was equivalent to the chicken cell culture, the time period for achieving it was decreased to half. Some of the prerequisites of inactivated influenza virus vaccine production include generation of higher vial titer, independence from exogenous sources, and decrease in the production time lines. Based on the tests, it can be concluded that chicken embryo primary cell culture addresses these issues and can serve as a potential alternative for influenza virus vaccine production. PMID:23515853

Babar, Mustafeez Mujtaba; Riaz, Muhammad Suleman; Zaidi, Najam-us-Sahar Sadaf; Afzal, Farhan; Farooq, Muhammad Sabir

2013-03-21

230

Flow cytometric monitoring of influenza A virus infection in MDCK cells during vaccine production  

Microsoft Academic Search

BACKGROUND: In cell culture-based influenza vaccine production the monitoring of virus titres and cell physiology during infection is of great importance for process characterisation and optimisation. While conventional virus quantification methods give only virus titres in the culture broth, data obtained by fluorescence labelling of intracellular virus proteins provide additional information on infection dynamics. Flow cytometry represents a valuable tool

Josef Schulze-Horsel; Yvonne Genzel; Udo Reichl

2008-01-01

231

Biological production of ethanol from coal  

SciTech Connect

Two batch and one continuous reactor study involving Clostridium ljungdahlii were carried out. First, the effects of H{sub 2} partial pressure on growth, CO and H{sub 2} uptake and product formation by C. ljungdahlii were investigated in batch culture. Over the concentration range studied, it was observed that CO was preferentially utilized in favor of H{sub 2}. It was also seen that increasing H{sub 2} partial pressures increased the ratio of ethanol to acetate. Finally, a two-stage CSTR system was successfully operated with C. ljungdahlii in which growth occurred in the first stage and ethanol production occurred in the second stage.

Not Available

1989-01-01

232

[The topicality of return to smallpox vaccination: problems and prospects].  

PubMed

Nowadays there are certain facts which evidence the necessity of return to smallpox vaccination in Russia, especially concerning people who will be engaged in the liquidation of the nidi of this infection, should such appear. Smallpox virus is kept in laboratories of some countries; there is a real threat of biological terrorism; population immunity to smallpox infection is virtually absent. Considering the present situation in development and production of smallpox vaccines and remedies against vaccine-related complications, the tactics of population vaccination in Russia may vary. The main problems concerning return to smallpox vaccination in Russia are the following: there are no modern schemes (schedules) of smallpox immunization; there are no currently available and safe vaccines for primary immunization of adults; there are no preparations for prevention and treatment of vaccine-related complications. Thus, the priority areas are: development of effective and safe oral adult vaccines for primary immunization; production of human and heterologous immune globulins and their storage. PMID:16924876

Onishchenko, G G; Maksimov, V A; Vorob'ev, A A; Podku?ko, V N; Mel'nikov, S A

2006-01-01

233

Center for Biologics Evaluation and Research, FY2007 Annual Report.  

National Technical Information Service (NTIS)

CBER works at the cutting edge of public health and science, regulating complex biological products that are essential to medicine and public health in the 21st Century. These products, which include vaccines, allergenics, blood and blood products, and ce...

2008-01-01

234

Minimization of excess sludge production for biological wastewater treatment  

Microsoft Academic Search

Excess sludge treatment and disposal currently represents a rising challenge for wastewater treatment plants (WWTPs) due to economic, environmental and regulation factors. There is therefore considerable impetus to explore and develop strategies and technologies for reducing excess sludge production in biological wastewater treatment processes. This paper reviews current strategies for reducing sludge production based on these mechanisms: lysis-cryptic growth, uncoupling

Yuansong Wei; Renze T. Van Houten; Arjan R. Borger; Dick H. Eikelboom; Yaobo Fan

2003-01-01

235

Biologically based pest controls: Markets, industries, and products. Special report  

Microsoft Academic Search

Numbers and amounts of conventional pesticides to combat insect pests, weeds and plant diseases are likely to decline. Although biologically based pest control products have been touted as possible replacements, such products now comprise less than 2% of the market in the United States. Twelve large multinational companies market 80% of the world`s pesticides, valued at about $200 billion, and

R. L. Ridgway; M. N. Inscoe; K. W. Thorpe

1994-01-01

236

IMMUNOLOGY AND MOLECULAR BIOLOGY Immune Response to a Mucosally Administered Aflatoxin B1 Vaccine  

Microsoft Academic Search

In the present study, a mucosal vaccine was used in an effort to elicit serum IgG and intestinal secretory IgA against the mycotoxin aflatoxin B1 (AFB) in chickens. AFB was coupled to carrier proteins (BSA and porcine thyroglobulin) for use as a vaccine and ELISA coating antigen, respectively. Seven-day-old broiler chicks were divided into groups of 10 and immunized with

J. Wilkinson; D. Rood; D. Minior; K. Guillard; M. Darre; L. K. Silbart

237

Biological production of ethanol from coal  

SciTech Connect

The fermentation pH has been observed to be the key parameter affecting the ratio of ethanol to acetate produced by Clostridium ljungdahlii. The effects of controlled pH on cell growth and product formation by C. ljungdahlii were measured. It was found that cell concentration and acetate concentration increased with pH, while the ethanol concentration was highest at the lower pH. The molar product ratio of ethanol to acetate was 0.74 at pH 4.0, 0.39 at pH 4.5 and 0.12 at pH 5.0. Future experiments will concentrate on studying other important parameters such as agitation rate and nutrients concentrations with controlled pH as a preclude to continuous reactor studies.

Not Available

1990-01-01

238

Biological production of ethanol from coal  

SciTech Connect

Research is continuing in attempting to increase both the ethanol concentration and product ratio (acetate to ethanol) from the C. ljungdahlii fermentation. Both batch and continuous reactors are being used for this purpose. The purpose of this report is four-fold. First, the data presented in PETC Report No. 2-4-91 (June--September, 1991) are analyzed and interpreted using normalized specific growth and production rates. This technique eliminates experimental variation due to differences in inoculum history. Secondly, the effects of the sulfur gases H{sub 2}S and COS on the performance of C. ljungdahlii are presented and discussed. Although these are preliminary results, they illustrate the tolerance of the bacterium to low levels of sulfur gases. Thirdly, the results of continuous stirred tank reactor studies are presented, where cell and product concentrations are shown as a function of agitation rate and gas flow rate. Finally, additional data are presented showing the performance of C. ljungdahlii in a CSTR with cell recycle.

Not Available

1992-05-01

239

Biological production of ethanol from coal  

SciTech Connect

Research is continuing in attempting to increase both the ethanol concentration and product ratio from the C. ljungdahlii fermentation. Both batch and continuous reactors are being used for this purpose. The purpose of this report is four-fold. First, the data presented in PETC Report No. 2-4-91 (June--September 1991) are analyzed and interpreted using normalized specific growth and production rates. This technique eliminates experimental variation due to the differences in inoculum history. Secondly, the effects of the sulfur gases H{sub 2}S and COS on the performance of C. ljungdahlii are presented and discussed. Although these are preliminary results, they illustrate the tolerance of the bacterium to low levels of sulfur gases. Thirdly, the results of continuous stirred tank reactor studies are presented, where cell and product concentrations are shown as a function of agitation rate and gas flow rate. Finally, additional data are presented showing the performance of C. ljungdahlii in a CSTR with cell recycle.

Not Available

1991-01-01

240

An Automated HIV-1 Env-Pseudotyped Virus Production for Global HIV Vaccine Trials  

PubMed Central

Background Infections with HIV still represent a major human health problem worldwide and a vaccine is the only long-term option to fight efficiently against this virus. Standardized assessments of HIV-specific immune responses in vaccine trials are essential for prioritizing vaccine candidates in preclinical and clinical stages of development. With respect to neutralizing antibodies, assays with HIV-1 Env-pseudotyped viruses are a high priority. To cover the increasing demands of HIV pseudoviruses, a complete cell culture and transfection automation system has been developed. Methodology/Principal Findings The automation system for HIV pseudovirus production comprises a modified Tecan-based Cellerity system. It covers an area of 5×3 meters and includes a robot platform, a cell counting machine, a CO2 incubator for cell cultivation and a media refrigerator. The processes for cell handling, transfection and pseudovirus production have been implemented according to manual standard operating procedures and are controlled and scheduled autonomously by the system. The system is housed in a biosafety level II cabinet that guarantees protection of personnel, environment and the product. HIV pseudovirus stocks in a scale from 140 ml to 1000 ml have been produced on the automated system. Parallel manual production of HIV pseudoviruses and comparisons (bridging assays) confirmed that the automated produced pseudoviruses were of equivalent quality as those produced manually. In addition, the automated method was fully validated according to Good Clinical Laboratory Practice (GCLP) guidelines, including the validation parameters accuracy, precision, robustness and specificity. Conclusions An automated HIV pseudovirus production system has been successfully established. It allows the high quality production of HIV pseudoviruses under GCLP conditions. In its present form, the installed module enables the production of 1000 ml of virus-containing cell culture supernatant per week. Thus, this novel automation facilitates standardized large-scale productions of HIV pseudoviruses for ongoing and upcoming HIV vaccine trials.

Fuss, Martina; Mazzotta, Angela S.; Sarzotti-Kelsoe, Marcella; Ozaki, Daniel A.; Montefiori, David C.; von Briesen, Hagen; Zimmermann, Heiko; Meyerhans, Andreas

2012-01-01

241

Effect of biological pretreatments in enhancing corn straw biogas production  

Microsoft Academic Search

A biological pretreatment with new complex microbial agents was used to pretreat corn straw at ambient temperature (about 20°C) to improve its biodegradability and anaerobic biogas production. A complex microbial agent dose of 0.01% (w\\/w) and pretreatment time of 15days were appropriate for biological pretreatment. These treatment conditions resulted in 33.07% more total biogas yield, 75.57% more methane yield, and

Weizhang Zhong; Zhongzhi Zhang; Yijing Luo; Shanshan Sun; Wei Qiao; Meng Xiao

2011-01-01

242

Temporal trends in antibody production in captive grey, harp and hooded seals to a single administration immunocontraceptive vaccine  

Microsoft Academic Search

The temporal production of antibody to a single-administration immunocontraceptive vaccine, known to be immunocontraceptive in free-ranging female grey seals (Halichoerus grypus), was studied in captive grey seals, harp seals (Phoca groenlandica) and hooded seals (Cystophoracristata). The vaccine is based on liposome delivery of porcine zona pellucida antigens. When measured by antigen capture, the response of hooded and harp seals to

R. G Brown; W. D Bowen; J. D Eddington; W. C Kimmins; M Mezei; J. L Parsons; B Pohajdak

1997-01-01

243

Setting up a platform for plant-based influenza virus vaccine production in South Africa  

PubMed Central

Background During a global influenza pandemic, the vaccine requirements of developing countries can surpass their supply capabilities, if these exist at all, compelling them to rely on developed countries for stocks that may not be available in time. There is thus a need for developing countries in general to produce their own pandemic and possibly seasonal influenza vaccines. Here we describe the development of a plant-based platform for producing influenza vaccines locally, in South Africa. Plant-produced influenza vaccine candidates are quicker to develop and potentially cheaper than egg-produced influenza vaccines, and their production can be rapidly upscaled. In this study, we investigated the feasibility of producing a vaccine to the highly pathogenic avian influenza A subtype H5N1 virus, the most generally virulent influenza virus identified to date. Two variants of the haemagglutinin (HA) surface glycoprotein gene were synthesised for optimum expression in plants: these were the full-length HA gene (H5) and a truncated form lacking the transmembrane domain (H5tr). The genes were cloned into a panel of Agrobacterium tumefaciens binary plant expression vectors in order to test HA accumulation in different cell compartments. The constructs were transiently expressed in tobacco by means of agroinfiltration. Stable transgenic tobacco plants were also generated to provide seed for stable storage of the material as a pre-pandemic strategy. Results For both transient and transgenic expression systems the highest accumulation of full-length H5 protein occurred in the apoplastic spaces, while the highest accumulation of H5tr was in the endoplasmic reticulum. The H5 proteins were produced at relatively high concentrations in both systems. Following partial purification, haemagglutination and haemagglutination inhibition tests indicated that the conformation of the plant-produced HA variants was correct and the proteins were functional. The immunisation of chickens and mice with the candidate vaccines elicited HA-specific antibody responses. Conclusions We managed, after synthesis of two versions of a single gene, to produce by transient and transgenic expression in plants, two variants of a highly pathogenic avian influenza virus HA protein which could have vaccine potential. This is a proof of principle of the potential of plant-produced influenza vaccines as a feasible pandemic response strategy for South Africa and other developing countries.

2012-01-01

244

ACAM2000 clonal Vero cell culture vaccinia virus (New York City Board of Health strain)--a second-generation smallpox vaccine for biological defense.  

PubMed

The threat of smallpox as a biological weapon has spurred efforts to create stockpiles of vaccine for emergency preparedness. In lieu of preparing vaccine in animal skin (the original method), we cloned vaccinia virus (New York City Board of Health strain, Dryvax by plaque purification and amplified the clone in cell culture. The overarching goal was to produce a modern vaccine that was equivalent to the currently licensed Dryvax in its preclinical and clinical properties, and could thus reliably protect humans against smallpox. A variety of clones were evaluated, and many were unacceptably virulent in animal models. One clonal virus (ACAM1000) was selected and produced at clinical grade in MRC-5 human diploid cells. ACAM1000 was comparable to Dryvax in immunogenicity and protective activity but was less neurovirulent for mice and nonhuman primates. To meet requirements for large quantities of vaccine after the events of September 11th 2001, the ACAM1000 master virus seed was used to prepare vaccine (designated ACAM2000) at large scale in Vero cells under serum-free conditions. The genomes of ACAM1000 and ACAM2000 had identical nucleotide sequences, and the vaccines had comparable biological phenotypes. ACAM1000 and ACAM2000 were evaluated in three Phase 1 clinical trials. The vaccines produced major cutaneous reactions and evoked neutralizing antibody and cell-mediated immune responses in the vast majority of subjects and had a reactogenicity profile similar to that of Dryvax. PMID:15491873

Monath, Thomas P; Caldwell, Joseph R; Mundt, Wolfgang; Fusco, Joan; Johnson, Casey S; Buller, Mark; Liu, Jian; Gardner, Bridget; Downing, Greg; Blum, Paul S; Kemp, Tracy; Nichols, Richard; Weltzin, Richard

2004-10-01

245

Pilot Scale Production of Highly Efficacious and Stable Enterovirus 71 Vaccine Candidates  

PubMed Central

Background Enterovirus 71 (EV71) has caused several epidemics of hand, foot and mouth diseases (HFMD) in Asia and now is being recognized as an important neurotropic virus. Effective medications and prophylactic vaccine against EV71 infection are urgently needed. Based on the success of inactivated poliovirus vaccine, a prototype chemically inactivated EV71 vaccine candidate has been developed and currently in human phase 1 clinical trial. Principal Finding In this report, we present the development of a serum-free cell-based EV71 vaccine. The optimization at each step of the manufacturing process was investigated, characterized and quantified. In the up-stream process development, different commercially available cell culture media either containing serum or serum-free was screened for cell growth and virus yield using the roller-bottle technology. VP-SFM serum-free medium was selected based on the Vero cell growth profile and EV71 virus production. After the up-stream processes (virus harvest, diafiltration and concentration), a combination of gel-filtration liquid chromatography and/or sucrose-gradient ultracentrifugation down-stream purification processes were investigated at a pilot scale of 40 liters each. Although the combination of chromatography and sucrose-gradient ultracentrifugation produced extremely pure EV71 infectious virus particles, the overall yield of vaccine was 7–10% as determined by a VP2-based quantitative ELISA. Using chromatography as the downstream purification, the virus yield was 30–43%. To retain the integrity of virus neutralization epitopes and the stability of the vaccine product, the best virus inactivation was found to be 0.025% formalin-treatment at 37°C for 3 to 6 days. Furthermore, the formalin-inactivated virion vaccine candidate was found to be stable for >18 months at 4°C and a microgram of viral proteins formulated with alum adjuvant could induce strong virus-neutralizing antibody responses in mice, rats, rabbits, and non-human primates. Conclusion These results provide valuable information supporting the current cell-based serum-free EV71 vaccine candidate going into human Phase I clinical trials.

Chang, Cheng-Peng; Guo, Meng-Shin; Hsieh, Shih-Yang; Yang, Wen-Hsueh; Chao, Hsin-Ju; Wu, Chien-Long; Huang, Ju-Lan; Lee, Min-Shi; Hu, Alan Yung-Chi; Lin, Sue-Chen; Huang, Yu-Yun; Hu, Mei-Hua; Chow, Yen-Hung; Chiang, Jen-Ron; Chang, Jui-Yuan; Chong, Pele

2012-01-01

246

The feasibility of a novel bioreactor for vaccine production of classical swine fever virus.  

PubMed

The performance of a new type of tide mode culture system was investigated in this study. This novel bioreactor provides two separated stages, liquid and gas, for cell growth requirements. The immobilized cells absorbed the nutrient from medium during the liquid stage and subsequently were exposed directly to fresh air to absorb oxygen during the gas stage. Operating with PK15 cells under optimal conditions, we obtained 2.3×10(9) cells in 500ml reactor. It is 30 times higher than the initial inoculum and about 11 times higher than the production by roller bottle. For the vaccine production of classical swine fever (CSFV), a high virus titer of 2.1×10(9) median tissue culture infective dose (TCID(50)) was yielded which provided exceed 300 doses per milliliter of CSFV solution. Therefore, this new cultural system performed well not only for cell production but also for virus yield. It should be a highly efficient production for the CSFV vaccine and have practical potential in other animal cell culture vaccine. PMID:23261041

Wu, Sheng-Chi; Liau, Ming-Yi; Lin, Ya-Ching; Sun, Chong-Jun; Wang, Chi-Ting

2012-12-20

247

Improved production process for native outer membrane vesicle vaccine against Neisseria meningitidis.  

PubMed

An improved detergent-free process has been developed to produce vaccine based on native outer membrane vesicles (NOMV) against Neisseria meningitidis serogroup B. Performance was evaluated with the NonaMen vaccine concept, which provides broad coverage based on nine distinct PorA antigens. Scalable aseptic equipment was implemented, replacing undesirable steps like ultracentrifugation, inactivation with phenol, and the use of preservatives. The resulting process is more consistent and gives a higher yield than published reference processes, enabling NOMV production at commercial scale. Product quality met preliminary specifications for 9 consecutive batches, and an ongoing study confirmed real-time stability up to 12 months after production. As the NOMV had low endotoxic activity and induced high bactericidal titres in mice, they are expected to be safe and effective in humans. The production process is not limited to NonaMen and may be applicable for other N. meningitidis serogroups and other gram-negative pathogens. The current results therefore facilitate the late-stage development and clinical evaluation of NOMV vaccines. PMID:23741478

van de Waterbeemd, Bas; Zomer, Gijsbert; Kaaijk, Patricia; Ruiterkamp, Nicole; Wijffels, René H; van den Dobbelsteen, Germie P J M; van der Pol, Leo A

2013-05-31

248

The Structural Biology of Enzymes Involved in Natural Product Glycosylation  

PubMed Central

The glycosylation of microbial natural products often dramatically influences the biological and/or pharmacological activities of the parental metabolite. Over the past decade, crystal structures of several enzymes involved in the biosynthesis and attachment of novel sugars found appended to natural products have emerged. In many cases, these studies have paved the way to a better understanding of the corresponding enzyme mechanism of action and have served as a starting point for engineering variant enzymes to facilitate to production of differentially-glycosylated natural products. This review specifically summarizes the structural studies of bacterial enzymes involved in biosynthesis of novel sugar nucleotides.

Singh, Shanteri; Phillips, George N.

2012-01-01

249

Analysis of Cyanide and Its Breakdown Products in Biological Samples.  

National Technical Information Service (NTIS)

Cyanide is a toxic chemical that may be introduced into living organisms as a result of natural processes and/or anthropogenic uses (legal or illicit). Exposure to cyanide can be verified by analysis of cyanide or one of its breakdown products from biolog...

B. A. Logue D. M. Hinkens G. A. Rockwood S. I. Baskin

2010-01-01

250

75 FR 75682 - Reclassification of Category IIIA Biological Products, Bacterial Vaccines and Related Biological...  

Federal Register 2010, 2011, 2012, 2013

...the Development of Skin Lesion in Mice after Inoculation with Herpes Simplex Virus'' (Department of Microbiology, School of...the Development of Skin Lesion in Mice after Inoculation with Herpes Simplex Virus,'' Department of Microbiology, School of...

2010-12-06

251

The effects of ts-11 strain Mycoplasma gallisepticum vaccination in commercial layers on egg production and selected egg quality parameters.  

PubMed

Live Mycoplasma gallisepticum (MG) vaccines have been USDA approved and licensed for use in commercial layer chickens since 1988; however, egg production and egg quality data exist only for the F strain of MG. Information pertinent to the effects of ts-11 MG on egg and eggshell quality parameters, as well as egg size distribution, is lacking. In this study, pullets were inoculated at 10 wk of age with ts-11 strain MG and placed in biological isolation units at 10 birds/unit. Hen-day egg production, eggshell strength, Haugh unit score, pimpling incidence, and blood/meat spot incidence were monitored and recorded in each trial through a 45-wk production cycle. Further, eggs from all treatments were collected daily, Monday-Thursday, and individually weighed. Results of this study indicate that no significant difference was observed between the treatments for the parameters measured or for egg size distribution. Therefore, these data should lessen producers' concerns pertaining to the impact of ts-11 strain MG on egg production, egg and eggshell quality parameters, and egg size distribution. PMID:11007009

Branton, S L; Lott, B D; May, J D; Maslin, W R; Pharr, G T; Bearson, S D; Collier, S D; Boykin, D L

252

The aluminum content of biological products containing aluminum adjuvants: determination by atomic absorption spectrometry.  

PubMed

Aluminum compounds are used as adjuvants in certain types of vaccines, toxoids and allergenic extracts for human use. The most common Al compounds used in biological products to enhance the immune response are aluminum potassium sulphate (alum), aluminum hydroxide and aluminum phosphate. This study describes an atomic absorption spectrometric method for the determination of the Al content of Al adsorbed toxoid preparations and allergenic extracts at levels of less than 0.85 mg of Al per half millilitre human dose. Aliquots of the samples which contained Al suspensions were acid digested with nitric and sulphuric acid and analysed in the nitrous oxide-acetylene flame of an atomic absorption spectrometer. The 396.2 nm Al line was used for analysis. The Al content of the National Bureau of Standards (NBS) Standard Reference Material No. 1075a aluminum 2- ethylhexanoate was determined to within 1% of the NBS certificate value by this method. Atomic absorption results for the Al content of tetanus toxoids containing aluminum potassium sulphate and aluminum phosphate were compared with polarographic and inductively coupled argon plasma (ICP) emission spectrometry results. Reproducibility and recovery data for Al are tabulated for a variety of biological products containing aluminum phosphate, aluminum potassium sulphate and aluminum hydroxide adjuvants. In addition, ICP has been used to characterize the Al and P compositions of the precipitates and supernatant solutions which resulted from centrifuging toxoid suspensions that contained the three different Al adjuvants. PMID:6736048

May, J C; Progar, J J; Chin, R

1984-01-01

253

A TaqMan ® Reverse Transcription Polymerase Chain Reaction (RT-PCR) In Vitro Potency Assay for Plasmid-based Vaccine Products  

Microsoft Academic Search

A TaqMan®-based reverse transcription polymerase chain reaction (RT-PCR) assay has been developed as an in vitro potency assay to measure\\u000a the most immediate biological activity of plasmid DNA (pDNA)-based products. The assay measures transgene-specific messenger\\u000a RNA (mRNA) from cultured cells transfected with VCL-CB01, a bivalent pDNA-based human cytomegalovirus (CMV) vaccine. The forward\\u000a and reverse primers have been designed to make the

Rohit Mahajan; Beth Feher; Basil Jones; Doug Jones; Lana Marjerison; Mindy Sam; Jukka Hartikka; Mary Wloch; Peggy Lalor; David Kaslow; Keith Hall; Alain Rolland

2008-01-01

254

DNA vaccines  

NASA Astrophysics Data System (ADS)

Immunization by genes encoding immunogens, rather than with the immunogen itself, has opened up new possibilities for vaccine research and development and offers chances for new applications and indications for future vaccines. The underlying mechanisms of antigen processing, immune presentation and regulation of immune responses raise high expectations for new and more effective prophylactic or therapeutic vaccines, particularly for vaccines against chronic or persistent infectious diseases and tumors. Our current knowledge and experience of DNA vaccination is summarized and critically reviewed with particular attention to basic immunological mechanisms, the construction of plasmids, screening for protective immunogens to be encoded by these plasmids, modes of application, pharmacokinetics, safety and immunotoxicological aspects. DNA vaccines have the potential to accelerate the research phase of new vaccines and to improve the chances of success, since finding new immunogens with the desired properties is at least technically less demanding than for conventional vaccines. However, on the way to innovative vaccine products, several hurdles have to be overcome. The efficacy of DNA vaccines in humans appears to be much less than indicated by early studies in mice. Open questions remain concerning the persistence and distribution of inoculated plasmid DNA in vivo, its potential to express antigens inappropriately, or the potentially deleterious ability to insert genes into the host cell's genome. Furthermore, the possibility of inducing immunotolerance or autoimmune diseases also needs to be investigated more thoroughly, in order to arrive at a well-founded consensus, which justifies the widespread application of DNA vaccines in a healthy population.

Gregersen, Jens-Peter

2001-10-01

255

Biological hydrogen production: effects of pH and intermediate products  

Microsoft Academic Search

A series of batch tests were conducted to investigate the effects of pH and intermediate products on biological hydrogen production. The tests were run in serum bottles to determine the optimal operating conditions to maximize hydrogen production using sucrose and starch as organic substrates. Apart from hydrogen, variations in pH, volatile fatty acids, and solvent concentrations were also monitored. Initial

Samir Kumar Khanal; Wen-Hsing Chen; Ling Li; Shihwu Sung

2004-01-01

256

Gastrointestinal comorbidity, autistic regression and Measles-containing vaccines: positive re-challenge and biological gradient  

Microsoft Academic Search

Background: A temporal association between exposure to measles-containing vaccine (MCV) and autistic-like developmental regression in a sub- set of children with enterocolitis has been reported. Measles virus (MV) was detected in ileal biopsies from these children at higher prevalence than in developmentally normal pediatric controls. This study tested the hypothesis of a dose-response effect of MCV exposure on intestinal pathology,

Andrew J. Wakefield; Carol Stott

257

[Production of a vaccine against pseudoplague in poultry using the La Sota strain].  

PubMed

Comparative investigations were carried out on the quality and quantity of a vaccine against Newcastle disease in birds with the La Sota strain, obtained after the routinely applied productional technology or after some of the author's modifications of the method. The addition of penicillin, kanamycin, oleandomycin or chlorocid to the virus intended for an archive showed on unfavourable effect on the development of the chick embryos used; there was no such effect on the La Sota strain multiplying in them either. The industrial production of this vaccine with the addition of the above entibiotics used either alone or in combination had favourably influenced the sterility of the virus suspension. Data showed that at to and fro moving of the embryos following infection with the virus every two hours at an angle of 150 degrees C the number of dead embryos at the 76th hour was lower. The agglutination-reaction titer was considerably higher. A proof of high immunogenicity of the vaccines obtained was also the infectious titer of the virus in 11-old chick embryos--log 10(-9), on an average. On the 11th day of incubation the embryos infected with the La Sota strain of the virus had greater amounts of alanto-amnionic fluid than those kept in the incubator and infected on the 10th day. At infecting on the 11th day of age greater amounts of virus suspension were obtained without lowering of its infectious titer; thus, its immunogenic properties remained unchanged. PMID:941397

Cholakova, R

1976-01-01

258

Cell-free production of trimeric influenza hemagglutinin head domain proteins as vaccine antigens.  

PubMed

In order to effectively combat pandemic influenza threats, there is a need for more rapid and robust vaccine production methods. In this article, we demonstrate E. coli-based cell-free protein synthesis (CFPS) as a method to rapidly produce domains from the protein hemagglutinin (HA), which is present on the surface of the influenza virus. The portion of the HA coding sequence for the "head" domain from the 2009 pandemic H1N1 strain was first optimized for E. coli expression. The protein domain was then produced in CFPS reactions and purified in soluble form first as a monomer and then as a trimer by a C-terminal addition of the T4 bacteriophage foldon domain. Production of soluble trimeric HA head domain was enhanced by introducing stabilizing amino acid mutations to the construct in order to avoid aggregation. Trimerization was verified using size exclusion HPLC, and the stabilized HA head domain trimer was more effectively recognized by antibodies from pandemic H1N1 influenza vaccine recipients than was the monomer and also bound to sialic acids more strongly, indicating that the trimers are correctly formed and could be potentially effective as vaccines. PMID:22729608

Welsh, John P; Lu, Yuan; He, Xiao-Song; Greenberg, Harry B; Swartz, James R

2012-08-16

259

Technology transfer hub for pandemic influenza vaccine.  

PubMed

Increase of influenza vaccine production capacity in developing countries has been identified as an important element of global pandemic preparedness. Nevertheless, technology transfer for influenza vaccine production to developing country vaccine manufacturers has proven difficult because of lack of interested technology providers. As an alternative to an individual provider-recipient relationship, a technology and training platform (a "hub") for a generic non-proprietary process was established at a public sector European manufacturer's site. The conditions for setting up such a platform and the potential applicability of this model to other biologicals are discussed. PMID:19022316

Friede, M; Serdobova, I; Palkonyay, L; Kieny, M P

2008-11-18

260

Plague Vaccines  

Microsoft Academic Search

Plague has had a long and remarkable association with humankind, causing incalculable pain and suffering, thus it should not\\u000a be surprising that some of the first vaccine efforts were directed against this dreaded disease. The first effective plague\\u000a vaccines were developed through the efforts of the Pasteur Institute in the late 1890s. Although the first products were whole-cell\\u000a killed vaccines,

Jeffrey J. Adamovicz; Gerard P. Andrews

261

Effects of Taishan Pinus massoniana pollen polysaccharide on immune response of rabbit haemorrhagic disease tissue inactivated vaccine and on production performance of Rex rabbits  

Microsoft Academic Search

Varied doses of Taishan Pinus massoniana pollen polysaccharide (TPPPS) and Astragalus polysaccharide (APS) extracted by hot water extraction and ethanol precipiration method were added to the vaccine in order to prepare polysaccharide-rabbit haemorrhagic disease (RHD) tissue inactivated vaccine. The purpose was to study effects of TPPPS on immune response of RHD tissue inactivated vaccine and on production performance of Rex

Kai Wei; Zhenhong Sun; Zhengui Yan; Yanling Tan; Hui wang; Xiaolin Zhu; Xinjian Wang; Pengcheng Sheng; Ruiliang Zhu

2011-01-01

262

2013 Biological Approvals  

Center for Biologics Evaluation and Research (CBER)

... Print; Share; E-mail. Home; Vaccines, Blood & Biologics; Development & Approval Process (Biologics); ... Development & Approval Process (Biologics). ... More results from www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologicalapprovalsbyyear

263

9 CFR 102.5 - U.S. Veterinary Biological Product License.  

Code of Federal Regulations, 2010 CFR

...submit a list of licensed biological products prepared in the licensed...product or provisions that the biological product is restricted to use...distribution and use of a veterinary biological product be restricted...Management and Budget under control number 0579-0013)...

2009-01-01

264

9 CFR 102.5 - U.S. Veterinary Biological Product License.  

Code of Federal Regulations, 2013 CFR

...submit a list of licensed biological products prepared in the licensed...product or provisions that the biological product is restricted to use...distribution and use of a veterinary biological product be restricted...Management and Budget under control number 0579-0013)...

2013-01-01

265

9 CFR 102.5 - U.S. Veterinary Biological Product License.  

Code of Federal Regulations, 2010 CFR

...submit a list of licensed biological products prepared in the licensed...product or provisions that the biological product is restricted to use...distribution and use of a veterinary biological product be restricted...Management and Budget under control number 0579-0013)...

2010-01-01

266

Formate Formation and Formate Conversion in Biological Fuels Production  

PubMed Central

Biomethanation is a mature technology for fuel production. Fourth generation biofuels research will focus on sequestering CO2 and providing carbon-neutral or carbon-negative strategies to cope with dwindling fossil fuel supplies and environmental impact. Formate is an important intermediate in the methanogenic breakdown of complex organic material and serves as an important precursor for biological fuels production in the form of methane, hydrogen, and potentially methanol. Formate is produced by either CoA-dependent cleavage of pyruvate or enzymatic reduction of CO2 in an NADH- or ferredoxin-dependent manner. Formate is consumed through oxidation to CO2 and H2 or can be further reduced via the Wood-Ljungdahl pathway for carbon fixation or industrially for the production of methanol. Here, we review the enzymes involved in the interconversion of formate and discuss potential applications for biofuels production.

Crable, Bryan R.; Plugge, Caroline M.; McInerney, Michael J.; Stams, Alfons J. M.

2011-01-01

267

Formate formation and formate conversion in biological fuels production.  

PubMed

Biomethanation is a mature technology for fuel production. Fourth generation biofuels research will focus on sequestering CO(2) and providing carbon-neutral or carbon-negative strategies to cope with dwindling fossil fuel supplies and environmental impact. Formate is an important intermediate in the methanogenic breakdown of complex organic material and serves as an important precursor for biological fuels production in the form of methane, hydrogen, and potentially methanol. Formate is produced by either CoA-dependent cleavage of pyruvate or enzymatic reduction of CO(2) in an NADH- or ferredoxin-dependent manner. Formate is consumed through oxidation to CO(2) and H(2) or can be further reduced via the Wood-Ljungdahl pathway for carbon fixation or industrially for the production of methanol. Here, we review the enzymes involved in the interconversion of formate and discuss potential applications for biofuels production. PMID:21687599

Crable, Bryan R; Plugge, Caroline M; McInerney, Michael J; Stams, Alfons J M

2011-05-24

268

Norovirus P particle, a novel platform for vaccine development and antibody production.  

PubMed

The norovirus P particle is an octahedral nanoparticle formed by 24 copies of the protrusion (P) domain of the norovirus capsid protein. This P particle is easily produced in Escherichia coli, extremely stable, and highly immunogenic. There are three surface loops per P domain, making a total of 72 loops per particle, and these are potential sites for foreign antigen presentation for immune enhancement. To prove this concept, a small peptide (His tag, 7 amino acids [aa]) and a large antigen (rotavirus VP8, 159 aa) were inserted into one of the loops. Neither insertion affects P particle formation, while both antigens were presented well on the P particle surface. The immune-enhancement effect of the P particle was demonstrated by significantly increased antibody titers induced by the P particle-presented antigens compared to the titers induced by free antigens. In addition, the measured neutralization antibody titers and levels of protection against rotavirus shedding in mice immunized with the VP8 chimeric P particles were significantly higher than those of mice immunized with the free VP8 antigen. Sera from P particle-VP8 chimera-vaccinated animals also blocked norovirus virus-like particle (VLP) binding to the histo-blood group antigen (HBGA) receptors. From these data, the P particle appears to be an excellent vaccine platform for antigen presentation. The readily available three surface loops and the great capacity for foreign antigen insertion make this platform attractive for wide application in vaccine development and antibody production. The P particle-VP8 chimeras may serve as a dual vaccine against both rotavirus and norovirus. PMID:21068235

Tan, Ming; Huang, Pengwei; Xia, Ming; Fang, Ping-An; Zhong, Weiming; McNeal, Monica; Wei, Chao; Jiang, Wen; Jiang, Xi

2010-11-10

269

The in vivo production of specific human antibodies by vaccination of human-PBL-SCID mice.  

PubMed Central

Human-PBL-SCID animals were created by intraperitoneal (i.p.) transfer of human peripheral blood lymphocytes (PBL) or PBL depleted of CD8-expressing lymphocytes (CD8dL). Analysis of human immunoglobulin levels in these animals revealed that severe combined immunodeficiency (SCID) mice receiving CD8dL produced significantly higher levels of serum human immunoglobulin than those receiving PBL. In an attempt to induce antigen-specific human antibodies these human-PBL-SCID animals were vaccinated with soluble protein antigen [ovalbumin (OVA)] entrapped within liposomes as an immunological adjuvant. Vaccination produced antigen-specific human IgM and IgG in human-PBL-SCID mouse serum. The use of liposomes as adjuvant and the reconstitution of animals with CD8dL together enhanced the OVA-specific immune response as evidenced by the detection of significantly increased serum antibody titres. In the CD8dL reconstituted group, solid tumours of human B-cell origin became detectable in the peritoneal cavity of animals at 8-10 weeks post-reconstitution. These tumours were readily established in vitro and subsequent analysis of culture supernatants showed that these malignant cells continue to secrete human antibodies specific for the original immunizing antigen in vitro. We believe this vaccination of the human-PBL-SCID mouse to produce antigen-specific human antibodies, may find use in the future production of human monoclonal antibodies and in the testing and development of novel vaccine/adjuvant systems.

Walker, W; Gallagher, G

1994-01-01

270

Sustainable coccidiosis control in poultry production: the role of live vaccines  

Microsoft Academic Search

The development of new methods of administering coccidiosis vaccines has facilitated their use in the hatchery and thereby improved prospects for the economic vaccination of broilers. The acquisition of protective immunity to Eimeria species is boosted by further exposure to infection after vaccination. Factors that affect the reproductive efficiency of non-attenuated and attenuated vaccines are considered and the key role

H. D Chapman; T. E Cherry; H. D Danforth; G Richards; M. W Shirley; R. B Williams

2002-01-01

271

Similar Biological Medicinal Products Containing Recombinant Human Growth Hormone: European Regulation  

Microsoft Academic Search

The concept of similar biological medicinal products (‘biosimilar’ medicinal products) allows pharmaceutical companies to develop products based on an abridged dossier once the marketing protection of the ‘reference’ biological medicinal product has expired. A biosimilar medicinal product can be granted a marketing authorization provided that its similarity to a reference product is established in terms of quality, safety and efficacy

Mira Pavlovic; Elizabeth Girardin; Liliana Kapetanovic; Kowid Ho; Jean-Hugues Trouvin

2008-01-01

272

Biological treatment of chicken feather waste for improved biogas production.  

PubMed

A two-stage system was developed which combines the biological degradation of keratin-rich waste with the production of biogas. Chicken feather waste was treated biologically with a recombinant Bacillus megaterium strain showing keratinase activity prior to biogas production. Chopped, autoclaved chicken feathers (4%, W/V) were completely degraded, resulting in a yellowish fermentation broth with a level of 0.51 mg/mL soluble proteins after 8 days of cultivation of the recombinant strain. During the subsequent anaerobic batch digestion experiments, methane production of 0.35 Nm3/kg dry feathers (i.e., 0.4 Nm3/kg volatile solids of feathers), corresponding to 80% of the theoretical value on proteins, was achieved from the feather hydrolyzates, independently of the pre-hydrolysis time period of 1, 2 or 8 days. Cultivation with a native keratinase producing strain, Bacillus licheniformis resulted in only 0.25 mg/mL soluble proteins in the feather hydrolyzate, which then was digested achieving a maximum accumulated methane production of 0.31 Nm3/kg dry feathers. Feather hydrolyzates treated with the wild type B. megaterium produced 0.21 Nm3 CH4/kg dry feathers as maximum yield. PMID:22432272

Forgács, Gergely; Alinezhad, Saeid; Mirabdollah, Amir; Feuk-Lagerstedt, Elisabeth; Horváth, Ilona Sárvári

2011-01-01

273

Rapid onset of protection following vaccination of calves with multivalent vaccines containing modified-live or modified-live and killed BHV-1 is associated with virus-specific interferon gamma production  

Microsoft Academic Search

The objective of this study was to determine the effect of vaccination with commercially-available multivalent vaccines containing either modified-live (MLV) bovine herpesvirus-1 (BHV-1) (Bovishield®) or MLV plus killed (MLV+K) BHV-1 (Reliant® Plus) on protection against challenge at 5 days after a single vaccination. An additional objective was to determine whether cell-mediated immunity as measured by virus-specific interferon gamma (IFN-?) production

Amelia R Woolums; Leonardo Siger; Scott Johnson; Guillermo Gallo; Jennifer Conlon

2003-01-01

274

Biological and genetic properties of SA??-14-2, a live-attenuated Japanese encephalitis vaccine that is currently available for humans.  

PubMed

Japanese encephalitis virus (JEV), a mosquito-borne flavivirus, is a major cause of acute encephalitis, a disease of significance for global public health. In the absence of antiviral therapy to treat JEV infection, vaccination is the most effective method of preventing the disease. In JE-endemic areas, the most widely used vaccine to date is SA(14)-14-2, a live-attenuated virus derived from its virulent parent SA(14). In this study, we describe the biological properties of SA(14)-14-2, both in vitro and in vivo, and report the genetic characteristics of its genomic RNA. In BHK-21 (hamster kidney) cells, SA(14)-14-2 displayed a slight delay in plaque formation and growth kinetics when compared to a virulent JEV strain, CNU/LP2, with no decrease in maximum virus production. The delay in viral growth was also observed in two other cell lines, SH-SY5Y (human neuroblastoma) and C6/36 (mosquito larva), which are potentially relevant to JEV pathogenesis and transmission. In 3-week-old ICR mice, SA(14)-14-2 did not cause any symptoms or death after either intracerebral or peripheral inoculation with a maximum dose of up to 1.5×10(3) plaque-forming units (PFU) per mouse. The SA(14)-14-2 genome consisted of 10977 nucleotides, one nucleotide longer than all the previously reported genomes of SA(14)-14-2, SA(14) and two other SA(14)-derived attenuated viruses. This difference was due to an insertion of one G nucleotide at position 10701 in the 3 noncoding region. Also, we noted a significant number of nucleotide and/or amino acid substitutions throughout the genome of SA(14)-14-2, except for the prM protein-coding region, that differed from SA(14) and/or the other two attenuated viruses. Our results, together with others', provide a foundation not only for the study of JEV virulence but also for the development of new and improved vaccines for JEV. PMID:22923123

Song, Byung-Hak; Yun, Gil-Nam; Kim, Jin-Kyoung; Yun, Sang-Im; Lee, Young-Min

2012-08-25

275

9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.  

Code of Federal Regulations, 2010 CFR

...administered experimental biological products or live organisms...or research sponsor to control disposition of all animals...administered experimental biological products or live organisms...including challenged control animals) shall...

2010-01-01

276

9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.  

Code of Federal Regulations, 2010 CFR

...administered experimental biological products or live organisms...or research sponsor to control disposition of all animals...administered experimental biological products or live organisms...including challenged control animals) shall...

2009-01-01

277

9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.  

Code of Federal Regulations, 2013 CFR

...administered experimental biological products or live organisms...or research sponsor to control disposition of all animals...administered experimental biological products or live organisms...including challenged control animals) shall...

2013-01-01

278

21 CFR 510.4 - Biologics; products subject to license control.  

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Biologics; products subject to license control. 510.4 Section 510.4 Food... General Provisions § 510.4 Biologics; products subject to license control. An animal drug produced...

2013-04-01

279

21 CFR 510.4 - Biologics; products subject to license control.  

Code of Federal Regulations, 2010 CFR

...2009-04-01 2009-04-01 false Biologics; products subject to license control. 510.4 Section 510.4 Food... General Provisions § 510.4 Biologics; products subject to license control. An animal drug produced...

2009-04-01

280

Medical Research Center's (NMRC) Malaria Vaccine ...  

Center for Biologics Evaluation and Research (CBER)

... Enter Search terms. Vaccines, Blood & Biologics. ... Medical Research Center's (NMRC) Malaria Vaccine Development Program. -. Presentation. ... More results from www.fda.gov/biologicsbloodvaccines/newsevents/workshopsmeetingsconferences

281

Molecular biology in studies of oceanic primary production  

SciTech Connect

Remote sensing and the use of moored in situ instrumentation has greatly improved our ability to measure phytoplankton chlorophyll and photosynthesis on global scales with high temporal resolution. However, the interpretation of these measurements and their significance with respect to the biogeochemical cycling of carbon relies on their relationship with physiological and biochemical processes in phytoplankton. For example, the use of satellite images of surface chlorophyll to estimate primary production is often based on the functional relationship between photosynthesis and irradiance. A variety of environmental factors such as light, temperature, nutrient availability affect the photosynthesis/irradiance (P vs I) relationship in phytoplankton. We present three examples showing how molecular biology can be used to provide basic insight into the factors controlling primary productivity at three different levels of complexity: 1. Studies of light intensity regulation in unicellular alga show how molecular biology can help understand the processing of environmental cues leading to the regulation of photosynthetic gene expression. 2. Probing of the photosynthetic apparatus using molecular techniques can be used to test existing mechanistic models derived from the interpretation of physiological and biophysical measurements. 3. Exploratory work on the expression of specific proteins during nutrient-limited growth of phytoplankton may lead to the identification and production of molecular probes for field studies.

LaRoche, J.; Falkowski, P.G. (Brookhaven National Lab., Upton, NY (United States)); Geider, R. (Delaware Univ., Lewes, DE (United States). Coll. of Marine Studies)

1992-01-01

282

Molecular biology in studies of oceanic primary production  

SciTech Connect

Remote sensing and the use of moored in situ instrumentation has greatly improved our ability to measure phytoplankton chlorophyll and photosynthesis on global scales with high temporal resolution. However, the interpretation of these measurements and their significance with respect to the biogeochemical cycling of carbon relies on their relationship with physiological and biochemical processes in phytoplankton. For example, the use of satellite images of surface chlorophyll to estimate primary production is often based on the functional relationship between photosynthesis and irradiance. A variety of environmental factors such as light, temperature, nutrient availability affect the photosynthesis/irradiance (P vs I) relationship in phytoplankton. We present three examples showing how molecular biology can be used to provide basic insight into the factors controlling primary productivity at three different levels of complexity: 1. Studies of light intensity regulation in unicellular alga show how molecular biology can help understand the processing of environmental cues leading to the regulation of photosynthetic gene expression. 2. Probing of the photosynthetic apparatus using molecular techniques can be used to test existing mechanistic models derived from the interpretation of physiological and biophysical measurements. 3. Exploratory work on the expression of specific proteins during nutrient-limited growth of phytoplankton may lead to the identification and production of molecular probes for field studies.

LaRoche, J.; Falkowski, P.G. [Brookhaven National Lab., Upton, NY (United States); Geider, R. [Delaware Univ., Lewes, DE (United States). Coll. of Marine Studies

1992-07-01

283

Process optimization and scale-up for production of rabies vaccine live adenovirus vector (AdRG1.3).  

PubMed

Rabies virus is an important causative agent of disease resulting in an acute infection of the nervous system and death. Although curable if treated in a timely manner, rabies remains a serious public health issue in developing countries, and the indigenous threat of rabies continues in developed countries because of wildlife reservoirs. Control of rabies in wildlife is still an important challenge for governmental authorities. There are a number of rabies vaccines commercially available for control of wildlife rabies infection. However, the vaccines currently distributed to wildlife do not effectively immunize all at-risk species, particularly skunks. A replication competent recombinant adenovirus expressing rabies glycoprotein (AdRG1.3) has shown the most promising results in laboratory trials. The adenovirus vectored vaccine is manufactured using HEK 293 cells. This study describes the successful scale-up of AdRG1.3 adenovirus production from 1 to 500 L and the manufacturing of large quantities of bulk material required for field trials to demonstrate efficacy of this new candidate vaccine. The production process was streamlined by eliminating a medium replacement step prior to infection and the culture titer was increased by over 2 fold through optimization of cell culture medium. These improvements produced a more robust and cost-effective process that facilitates industrialization and commercialization. Over 17,000 L of AdRG1.3 adenovirus cultures were manufactured to support extensive field trials. AdRG1.3 adenovirus is formulated and packaged into baits by Artemis Technologies Inc. using proprietary technology. Field trials of AdRG1.3 rabies vaccine baits have been conducted in several Canadian provinces including Ontario, Quebec and New Brunswick. The results from field trials over the period 2006-2009 demonstrated superiority of the new vaccine over other licensed vaccines in immunizing wild animals that were previously difficult to vaccinate. PMID:22079076

Shen, Chun Fang; Lanthier, Stephane; Jacob, Danielle; Montes, Johnny; Beath, Alex; Beresford, Andrew; Kamen, Amine

2011-11-08

284

9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.  

Code of Federal Regulations, 2010 CFR

...to have any such veterinary biological product in their possession...importation of any such veterinary biological product. All notifications...s) of any such veterinary biological product at each location in...Management and Budget under control number 0579-0318.)...

2009-01-01

285

9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.  

Code of Federal Regulations, 2010 CFR

...to have any such veterinary biological product in their possession...importation of any such veterinary biological product. All notifications...s) of any such veterinary biological product at each location in...Management and Budget under control number 0579-0318.)...

2010-01-01

286

21 CFR 310.4 - Biologics; products subject to license control.  

Code of Federal Regulations, 2013 CFR

...Biologics; products subject to license control. 310.4 Section 310.4 Food...Biologics; products subject to license control. (a) If a drug has an approved...obtain marketing approval for radioactive biological products for human use, as defined...

2013-04-01

287

9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.  

Code of Federal Regulations, 2013 CFR

...to have any such veterinary biological product in their possession...importation of any such veterinary biological product. All notifications...s) of any such veterinary biological product at each location in...Management and Budget under control number 0579-0318)...

2013-01-01

288

Remotely sensed biological production in the equatorial Pacific.  

PubMed

A combination of ship, buoy, and satellite observations in the tropical Pacific during the period from 1992 to 2000 provides a basin-scale perspective on the net effects of El Niño and La Niña on biogeochemical cycles. New biological production during the 1997-99 El Niño/La Niña period varied by more than a factor of 2. The resulting interannual changes in global carbon sequestration associated with the El Niño/La Niña cycle contributed to the largest known natural perturbation of the global carbon cycle over these time scales. PMID:11463910

Turk, D; McPhaden, M J; Busalacchi, A J; Lewis, M R

2001-07-20

289

[A method of production of concentrated and purified vaccine against Chlamydia abortion in sheep and its testing in guinea pigs].  

PubMed

A method was developed for the production of a new, present day, concentrated depot-vaccine against the chlamydial abortion of sheep. Employed were a number of methods -- those with chick embryos, freezing and thawing with the use of liquid nitrogen, inactivation with formalin, purifying and concentration through differential centrifugation and supercentrifugation, with the use of an aluminum hydroxide ingredient, electron microscopy, and the respective control series, etc. The vaccine is characterized by low dosing, complete innocuity, and unreactiveness. Guinea pigs immunized singly responded with the production of complement-fixing antibodies on the 30th day of an average titer ranging from 1:32 to 1:64. Two-fold immunization on the 1st and 30th day led to the production of antibodies of average titers within the 1:256-1:512 range as established by means of CFT. The vaccine was shown to have a low prime cost. PMID:6868364

Popov, G; Martinov, S

1983-01-01

290

WHO Expert Committee on biological standardization.  

PubMed

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains WHO recommendations and guidelines on Japanese encephalitis vaccine (inactivated), human; regulatory preparedness for human pandemic influenza vaccines; and clinical evaluation of meningococcal C conjugate vaccines. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances. PMID:22420130

2011-01-01

291

WHO Expert Committee on biological standardization.  

PubMed

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains WHO recommendations and guidelines on human papillomavirus vaccines; meningococcal A conjugate vaccines; and stability evaluation of vaccines. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances. PMID:22397172

2011-01-01

292

A Cucumber Mosaic Virus Based Expression System for the Production of Porcine Circovirus Specific Vaccines  

PubMed Central

Potential porcine circovirus type 2 (PCV2) capsid protein epitopes, suitable for expression on the surface of cucumber mosaic virus (CMV) particles were determined by a thorough analysis of the predicted PCV capsid protein structure. The ab initio protein structure prediction was carried out with fold recognition and threading methods. The putative PCV epitopes were selected on the basis of PCV virion models and integrated into the plant virus coat protein, after amino acid position 131. The recombinants were tested for infectivity and stability on different Nicotiana species and stable recombinant virus particles were purified. The particles were tested for their ability to bind to PCV induced porcine antibodies and used for specific antibody induction in mice and pigs. The results showed that PCV epitopes expressed on the CMV surface were recognized by the porcine antibodies and they were also able to induce PCV specific antibody response. Challenge experiment with PCV2 carried out in immunized pigs showed partial protection against the infection. Based on these results it was concluded that specific antiviral vaccine production for the given pathogen was feasible, offering an inexpensive way for the mass production of such vaccines.

Gellert, Akos; Salanki, Katalin; Tombacz, Kata; Tuboly, Tamas; Balazs, Ervin

2012-01-01

293

Comparison of initial feasibility of host cell lines for viral vaccine production.  

PubMed

In order to reduce the time required for the development and production of viral vaccines, host cell lines should be available as expression systems for production of viral vaccines against groups of viral pathogens. A selection of cell lines was compared for their initial feasibility as expression system for the replication of polioviruses, influenza A viruses and respiratory syncytial virus (wild type strain A2). Six adherent cell lines (Vero, HEK-293, MRC-5, CHO-K1, BHK-21 c13, MDCK) and six single cell suspension cell lines (CAP, AGE1.CR.HS, sCHO-K1, BHK-21 c13 2p, MDCK SFS) were studied for their ability to propagate viruses. First, maximum cell densities were determined. Second, virus receptor expression and polarization of the cell lines regarding receptor distribution of eight different viruses were monitored using flow cytometry and immunocytochemistry. Organization of the actin cytoskeleton was studied by transfection of the cells with Lifeact™, a construct coding for actin-EGFP. Finally, the ability to produce virus progeny of the viruses studied was assayed for each cell line. The results suggest that single cell suspension cell lines grown on serum free medium are the best candidates to serve as host cell lines for virus replication. PMID:23684847

Vlecken, Danielle H W; Pelgrim, Ralf P M; Ruminski, Slawomir; Bakker, Wilfried A M; van der Pol, Leo A

2013-05-14

294

Identification and optimization of critical process parameters for the production of NOMV vaccine against Neisseria meningitidis.  

PubMed

Outer membrane vesicles (OMV) are used as a vaccine against Neisseria meningitidis serogroup B and are traditionally produced with detergent-extraction to remove toxic lipopolysaccharide. Engineered strains with attenuated lipopolysaccharide allowed the use of native vesicles (NOMV) with improved stability and immunogenicity. In the NOMV production process detergents are omitted and vesicle release is stimulated with EDTA extraction (a chelating agent) to enable a higher yield. Many process parameters may change the EDTA extraction efficiency, but it is unknown what the optimal ranges for these parameters are in terms of quality. The present study systematically optimized EDTA extraction and was representative for production at large-scale. Two critical process parameters were identified, harvest point of the cultivation (harvest) and pH of the extraction buffer (pH), which significantly affected yield (7-fold) and bacterial lysis (35-fold). The other quality attributes remained unchanged. Optimization of harvest and pH revealed that the desired low bacterial lysis coincided with intermediate but sufficient yield. High functional immunogenicity and low toxicity of the optimized vaccine were also confirmed. The EDTA extraction is therefore a robust process step which produces high quality OMV if harvest and pH are controlled accurately. PMID:22464965

van de Waterbeemd, Bas; Streefland, Mathieu; van Keulen, Lonneke; van den Ijssel, Jan; de Haan, Alex; Eppink, Michel H; van der Pol, Leo A

2012-03-30

295

Current studies on physiological functions and biological production of lactosucrose.  

PubMed

Lactosucrose (O-?-D-galactopyranosyl-(1,4)-O-?-D-glucopyranosyl-(1,2)-?-D-fructofuranoside) is a trisaccharide formed from lactose and sucrose by enzymatic transglycosylation. This rare trisaccharide is a kind of indigestible carbohydrate, has good prebiotic effect, and promotes intestinal mineral absorption. It has been used as a functional ingredient in a range of food products which are approved as foods for specified health uses in Japan. Using lactose and sucrose as substrates, lactosucrose can be produced through transfructosylation by ?-fructofuranosidase from Arthrobacter sp. K-1 or a range of levansucrases, or through transgalactosylation by ?-galactosidase from Bacillus circulans. This article presented a review of recent studies on the physiological functions of lactosucrose and the biological production from lactose and sucrose by different enzymes. PMID:23828605

Mu, Wanmeng; Chen, Qiuming; Wang, Xiao; Zhang, Tao; Jiang, Bo

2013-07-05

296

Systems biological approaches towards understanding cellulase production by Trichoderma reesei.  

PubMed

Recent progress and improvement in "-omics" technologies has made it possible to study the physiology of organisms by integrated and genome-wide approaches. This bears the advantage that the global response, rather than isolated pathways and circuits within an organism, can be investigated ("systems biology"). The sequencing of the genome of Trichoderma reesei (teleomorph Hypocrea jecorina), a fungus that serves as a major producer of biomass-degrading enzymes for the use of renewable lignocellulosic material towards production of biofuels and biorefineries, has offered the possibility to study this organism and its enzyme production on a genome wide scale. In this review, I will highlight the use of genomics, transcriptomics, proteomics and metabolomics towards an improved and novel understanding of the biochemical processes that involve in the massive overproduction of secreted proteins. PMID:22750088

Kubicek, Christian P

2012-06-29

297

Optimizing vaccine development.  

PubMed

Optimizing the development of modern molecular vaccines requires a complex series of interdisciplinary efforts involving basic scientists, immunologists, molecular biologists, clinical vaccinologists, bioinformaticians and epidemiologists. This review summarizes some of the major issues that must be carefully considered. The intent of the authors is to briefly describe key components of the development process to give the reader an overview of the challenges faced from vaccine concept to vaccine delivery. Every vaccine requires unique features based on the biology of the pathogen, the nature of the disease and the target population for vaccination. This review presents general concepts relevant for the design and development of ideal vaccines protective against diverse pathogens. PMID:21631691

Hoft, Daniel F; Brusic, Vladimir; Sakala, Isaac G

2011-06-02

298

“Non-chemical” drugs: biologicals, protein therapeutics, vaccines and antisense therapeutics  

Microsoft Academic Search

\\u000a It has long been recognized that living organisms have an astonishing ability to develop biochemical survival strategies [1].\\u000a One example for such a strategy is the mammalian immune system — an adaptive response to evolutionary challenges by microorganisms.\\u000a In the past, numerous attempts have been made to exploit these endogenous “biological” survival strategies for medicine. One\\u000a of the first successful

Markus Müller

299

Combination Vaccines  

PubMed Central

The combination of diphtheria, tetanus, and pertussis vaccines into a single product has been central to the protection of the pediatric population over the past 50 years. The addition of inactivated polio, Haemophilus influenzae, and hepatitis B vaccines into the combination has facilitated the introduction of these vaccines into recommended immunization schedules by reducing the number of injections required and has therefore increased immunization compliance. However, the development of these combinations encountered numerous challenges, including the reduced response to Haemophilus influenzae vaccine when given in combination; the need to consolidate the differences in the immunization schedule (hepatitis B); and the need to improve the safety profile of the diphtheria, tetanus, and pertussis combination. Here, we review these challenges and also discuss future prospects for combination vaccines.

Skibinski, David AG; Baudner, Barbara C; Singh, Manmohan; O'Hagan, Derek T

2011-01-01

300

Schistosomiasis vaccines  

PubMed Central

Schistosomiasis is a major neglected tropical disease of public health importance to a billion people. An estimated 200 million people are currently infected; an additional 779 million individuals are at risk to acquire the infection in 74 countries. Despite many years of implementation of mass anti-parasitic drug therapy programs and other control measures, this disease has not been contained and continues to spread to new geographic areas.  The discovery of a protective vaccine still remains the most potentially effective means for the control of this disease, especially if the vaccine provides long-term immunity against the infection. A vaccine would contribute to the reduction of schistosomiasis morbidity through induced immune responses leading to decrease in parasite load and reduced egg production. This vaccine could be administered to children between the ages of 3 and 12 years to prevent severe infection in a particularly high risk population. This review summarizes the current status of schistosomiasis vaccine development.

Siddiqui, Bilal A.; Ganley-Leal, Lisa

2011-01-01

301

Biological production of monoethanolamine by engineered Pseudomonas putida S12.  

PubMed

Pseudomonas putida S12 was engineered for the production of monoethanolamine (MEA) from glucose via the decarboxylation of the central metabolite l-serine, which is catalyzed by the enzyme l-serine decarboxylase (SDC). The host was first evaluated for its tolerance towards MEA as well as its endogenous ability to degrade this alkanolamine. Growth inhibition was observed at MEA concentrations above 100mM, but growth was never completely arrested even at 750mM of MEA. P. putida S12 was able to catabolize MEA in the absence of ammonia, but deletion of the eutBC genes that encode ethanolamine ammonia-lyase (EAL) enzyme sufficed to eliminate this capacity. For the biological production of MEA, the sdc genes from Arabidopsis thaliana (full-length and a truncated version) and Volvox carteri were expressed in P. putida S12. From 20mM of glucose, negligible amounts of MEA were produced by P. putida S12 ?eutBC expressing the sdc genes from A. thaliana and V. carteri. However, 0.07mmol of MEA was obtained per g of cell dry weight of P. putida S12 ?eutBC expressing the truncated variant of the A. thaliana SDC. When the medium was supplemented with l-serine (30mM), MEA production increased to 1.25mmolMEAg(-1) CDW, demonstrating that l-serine availability was limiting MEA production. PMID:23876477

Foti, Mirjam; Médici, Rosario; Ruijssenaars, Harald J

2013-07-19

302

Influenza Vaccine: Issues Related to Production, Distribution, and Public Health Messages.  

National Technical Information Service (NTIS)

Annual vaccination is the main method for preventing seasonal influenza, which typically occurs in the United States from late fall to early spring. Manufacturers produce vaccine through a lengthy and complex process. Manufacturers and medical supply dist...

2007-01-01

303

FDA Parental Advisory on Flavored Tobacco Products -- What You Need To Know  

MedlinePLUS

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Tobacco Products en Español Home Tobacco Products Youth & Tobacco ... Flavors (Edition 2) - FDA Parental Advisory on Flavored Tobacco Products - What You Need To Know View PDF ( ...

304

Production of cell culture (MDCK) derived live attenuated influenza vaccine (LAIV) in a fully disposable platform process.  

PubMed

The majority of influenza vaccines are manufactured using embryonated hens' eggs. The potential occurrence of a pandemic outbreak of avian influenza might reduce or even eliminate the supply of eggs, leaving the human population at risk. Also, the egg-based production technology is intrinsically cumbersome and not easily scalable to provide a rapid worldwide supply of vaccine. In this communication, the production of a cell culture (Madin-Darby canine kidney (MDCK)) derived live attenuated influenza vaccine (LAIV) in a fully disposable platform process using a novel Single Use Bioreactor (SUB) is presented. The cell culture and virus infection was maintained in a disposable stirred tank reactor with PID control of pH, DO, agitation, and temperature, similar to traditional glass or stainless steel bioreactors. The application of this technology was tested using MDCK cells grown on microcarriers in proprietary serum free medium and infection with 2006/2007 seasonal LAIV strains at 25-30 L scale. The MDCK cell growth was optimal at the agitation rate of 100 rpm. Optimization of this parameter allowed the cells to grow at a rate similar to that achieved in the conventional 3 L glass stirred tank bioreactors. Influenza vaccine virus strains, A/New Caledonia/20/99 (H1N1 strain), A/Wisconsin/67/05 (H3N2 strain), and B/Malaysia/2506/04 (B strain) were all successfully produced in SUB with peak virus titers > or =8.6 log(10) FFU/mL. This result demonstrated that more than 1 million doses of vaccine can be produced through one single run of a small bioreactor at the scale of 30 L and thus provided an alternative to the current vaccine production platform with fast turn-around and low upfront facility investment, features that are particularly useful for emerging and developing countries and clinical trial material production. PMID:20589670

George, Meena; Farooq, Masiha; Dang, Thi; Cortes, Bernadette; Liu, Jonathan; Maranga, Luis

2010-08-15

305

Is biological productivity enhanced at the New England shelfbreak front?  

NASA Astrophysics Data System (ADS)

A two-dimensional (cross-shelf) numerical model of the mean seasonal circulation offshore of southern New England predicts upwelling at the shelfbreak front. Expected ramifications of this upwelling include enhancement of nutrient supply, phytoplankton biomass, and productivity. However, seasonal climatologies of chlorophyll based on both in situ data and satellite observations show no mean enhancement at the front. We investigate this apparent discrepancy with a four-component planktonic ecosystem model coupled to the two-dimensional physical model. Nutrient fields are restored to climatological values at depth, and upper ocean values evolve freely according to physical and biological forcing. Vertical diffusivity is based on seasonally averaged surface and bottom mixed layer depths compiled from in situ observations. The model reproduces the general pattern of the observed cross-shelf and seasonal variations of the chlorophyll distribution. It predicts a local enhancement of phytoplankton productivity at the shelfbreak in spring and summer as a result of the persistently upwelled nutrient-rich slope water. In the model, zooplankton grazing prevents accumulation of phytoplankton biomass at the site of the upwelling. The predicted enhancement of primary productivity (but not phytoplankton biomass) at the shelfbreak constitutes a hypothesis that could be tested in the future with suitable measurements from regional long-term observatories, such as the Ocean Observatories Initiative Pioneer Array.

Zhang, Weifeng G.; McGillicuddy, Dennis J.; Gawarkiewicz, Glen G.

2013-01-01

306

Biological production of ethanol from coal. Final report  

SciTech Connect

Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H{sub 2}, CO{sub 2}, CH{sub 4} and sulfur gases, is first produced using traditional gasification techniques. The CO, CO{sub 2} and H{sub 2} are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product if the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the ``wild strain`` produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.

Not Available

1992-12-01

307

Biological hydrogen production by dark fermentation: challenges and prospects towards scaled-up production.  

PubMed

Among different technologies of hydrogen production, bio-hydrogen production exhibits perhaps the greatest potential to replace fossil fuels. Based on recent research on dark fermentative hydrogen production, this article reviews the following aspects towards scaled-up application of this technology: bioreactor development and parameter optimization, process modeling and simulation, exploitation of cheaper raw materials and combining dark-fermentation with photo-fermentation. Bioreactors are necessary for dark-fermentation hydrogen production, so the design of reactor type and optimization of parameters are essential. Process modeling and simulation can help engineers design and optimize large-scale systems and operations. Use of cheaper raw materials will surely accelerate the pace of scaled-up production of biological hydrogen. And finally, combining dark-fermentation with photo-fermentation holds considerable promise, and has successfully achieved maximum overall hydrogen yield from a single substrate. Future development of bio-hydrogen production will also be discussed. PMID:21612910

RenNanqi; GuoWanqian; LiuBingfeng; CaoGuangli; DingJie

2011-05-24

308

Cancer Vaccines  

MedlinePLUS

... M. An overview of the immune system and technical advances in tumor antigen discovery and validation. Methods in Molecular Biology 2007; 360:277–318. [PubMed Abstract] Pazdur MP, Jones JL. Vaccines: an innovative approach to treating cancer. Journal of Infusion Nursing 2007; 30(3):173–178. [ ...

309

Comparative evaluation of conventional polymerase chain reaction (PCR), with loop-mediated isothermal amplification and SYBR green I-based real-time PCR for the quantitation of porcine circovirus-1 DNA in contaminated samples destined for vaccine production.  

PubMed

Porcine circovirus type1 (PCV1), described initially as a contaminant of a porcine kidney cell line, is ubiquitous within the swine population The presence of PCV1 in porcine cell lines can lead to contamination during both human and porcine vaccine production. Therefore, a rapid, specific, sensitive and practical method is needed for the detection of PCV1 in bio-products. The aim of this study was to compare three assays in their ability to accurately quantify PCV1 virus in biological samples, namely loop-mediated isothermal amplification (LAMP), SYBR green I-based real-time polymerase chain reaction (PCR) and conventional PCR. All assays yielded successful quantitation of PCV1 DNA and differentiated between PCV1-free and-contaminated cells. In addition, the results were specific for PCV1, since amplification of samples containing closely-related PCV2 or other pathogenic swine viruses yielded negative results. The lowest detection threshold of 10(2) copies was displayed by the SYBR green I-based real-time PCR assay. In addition, this assay was the most effective in detecting PCV1 contamination in a set of commercially available porcine vaccines. Therefore we conclude that SYBR green I-based real-time PCR is specific and sensitive for detecting PCV1 in biological samples and maybe used for quality control of vaccine and biomaterial production. PMID:23538038

Yang, Bo-Chao; Wang, Feng-Xue; Zhang, Shu-Qin; Song, Ni; Li, Jian-Xi; Yang, Zhi-Qiang; Wen, Yong-Jun; Wu, Hua

2013-03-26

310

THE EFFECT OF A TRIVALENT VACCINE AGAINST STAPHYLOCOCCUS AUREUS MASTITIS ON LYMPHOCYTE SUBPOPULATIONS, ANTIBODY PRODUCTION AND NEUTROPHIL PHAGOCYTOSIS  

Technology Transfer Automated Retrieval System (TEKTRAN)

The effect of a novel bovine mastitis trivalent vaccine, containing Staphylococcus aureus capsular polysaccharide type 5 (T5), 8 (T8) and 336 (T336), on lymphocyte subpopulations, antibody production, and neutrophil phagocytosis was evaluated. Twenty pregnant heifers were immunized with either the t...

311

Rubella Virus Vaccine Live  

Center for Biologics Evaluation and Research (CBER)

... Rubella Virus Vaccine Live. -. Product. MERUVAX II Merck & Co, Inc. -. Contact FDA. (800) 835-4709. (301) 827-1800. ocod ... More results from www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts

312

Hepatitis B Vaccine (Recombinant)  

Center for Biologics Evaluation and Research (CBER)

... Hepatitis B Vaccine (Recombinant). -. Products. Engerix-B; Recombivax HB. -. Contact FDA. (800) 835-4709. (301) 827-1800. ... More results from www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts

313

Hormones in international meat production: biological, sociological and consumer issues.  

PubMed

Beef and its products are an important source of nutrition in many human societies. Methods of production vary and include the use of hormonal compounds ('hormones') to increase growth and lean tissue with reduced fat deposition in cattle. The hormonal compounds are naturally occurring in animals or are synthetically produced xenobiotics and have oestrogenic (oestradiol-17beta and its esters; zeranol), androgenic (testosterone and esters; trenbolone acetate) or progestogenic (progesterone; melengestrol acetate) activity. The use of hormones as production aids is permitted in North American countries but is no longer allowed in the European Union (EU), which also prohibits the importation of beef and its products derived from hormone-treated cattle. These actions have resulted in a trade dispute between the two trading blocs. The major concern for EU authorities is the possibility of adverse effects on human consumers of residues of hormones and metabolites. Methods used to assess possible adverse effects are typical of those used by international agencies to assess acceptability of chemicals in human food. These include analysis of quantities present in the context of known biological activity and digestive, absorptive, post-absorptive and excretory processes. Particular considerations include the low quantities of hormonal compounds consumed in meat products and their relationships to endogenous production particularly in prepubertal children, enterohepatic inactivation, cellular receptor- and non-receptor-mediated effects and potential for interference with growth, development and physiological function in consumers. There is particular concern about the role of oestradiol-17beta as a carcinogen in certain tissues. Now subject to a 'permanent' EU ban, current evidence suggests that certain catechol metabolites may induce free-radical damage of DNA in cell and laboratory animal test systems. Classical oestrogen-receptor mediation is considered to stimulate proliferation in cells maintaining receptivity. Mathematical models describing quantitative relationships between consumption of small amounts of oestrogens in meat in addition to greater concentrations from endogenous production, chemical stoichiometry at cellular level and human pathology have not been developed. Such an approach will be necessary to establish 'molecular materiality' of the additional hormone intake as a component of relative risk assessment. The other hormones, although generally less well researched, are similarly subject to a range of tests to determine potentially adverse effects. The resulting limited international consensus relates to the application of the 'precautionary principle' and non-acceptance by the European Commission of the recommendations of the Codex Alimentarius Commission, which determined that meat from cattle, hormone-treated according to good practice, was safe for human consumers. The present review considers the hormone issue in the context of current international social methodology and regulation, recent advances in knowledge of biological activity of hormones and current status of science-based evaluation of food safety and risk for human consumers. PMID:19087409

Galbraith, Hugh

2002-12-01

314

Rotavirus Vaccines  

Center for Biologics Evaluation and Research (CBER)

... Rotavirus Vaccines. -. RotaTeq (Rotavirus Vaccine) Questions and Answers; RotaTeq (Rotavirus Vaccine) and Intussusception Information. -. -. -. ... More results from www.fda.gov/biologicsbloodvaccines/vaccines/questionsaboutvaccines

315

Competency development in antibody production in cancer cell biology  

SciTech Connect

This is the final report of a three-year, Laboratory Directed Research and Development (LDRD) project at Los Alamos National Laboratory (LANL). The main objective of this project was to develop a rapid recombinant antibody production technology. To achieve the objective, the authors employed (1) production of recombinant antigens that are important for cell cycle regulation and DNA repair, (2) immunization and specific selection of antibody-producing lymphocytes using the flow cytometry and magnetic bead capturing procedure, (3) construction of single chain antibody library, (4) development of recombinant vectors that target, express, and regulate the expression of intracellular antibodies, and (5) specific inhibition of tumor cell growth in tissue culture. The authors have accomplished (1) optimization of a selection procedure to isolate antigen-specific lymphocytes, (2) optimization of the construction of a single-chain antibody library, and (3) development of a new antibody expression vector for intracellular immunization. The future direction of this research is to continue to test the potential use of the intracellular immunization procedure as a tool to study functions of biological molecules and as an immuno-cancer therapy procedure to inhibit the growth of cancer cells.

Park, M.S.

1998-12-01

316

Effect of vaccination against Mycoplasma hyopneumoniae in pig herds with an all-in/all-out production system.  

PubMed

A multi-site field study was conducted to evaluate an inactivated Mycoplasma hyopneumoniae (Mh) vaccine in 14 pig herds infected by Mh and practising an all-in/all-out production system. In each herd, a vaccinated and control group of 250 pigs each were compared during the growing/finishing period with respect to performance parameters (major variables) and by means of clinical, serological and pathological parameters (ancillary variables). Mh vaccination significantly (P < 0.05) improved daily weight gain (+22 g), feed conversion ratio (-0.07), medication costs (-0.476 ECU/pig) (1 ECU = US$1.0269542), prevalence of pneumonia lesions (-14%) and severity of pneumonia lesions (-3%). Mortality rate, severity of coughing and carcass quality were not significantly influenced by Mh vaccination. Serological results of Mh and other respiratory pathogens are presented and discussed. A cost-benefit analysis based on significantly improved performance parameters demonstrated that Mh vaccination was economically attractive as it resulted in an increase of the net return to labour with 1.300 ECU per finishing pig sold. The sensitivity of the economic benefit was illustrated towards fluctuations in pig finishing prices. PMID:10195611

Maes, D; Deluyker, H; Verdonck, M; Castryck, F; Miry, C; Vrijens, B; Verbeke, W; Viaene, J; de Kruif, A

1999-03-01

317

Evaluation of allergen vaccine potency  

Microsoft Academic Search

The development of reliable and clinically relevant potency assays is essential to the practice of safe and effective allergen-specific\\u000a immunotherapy. Allergen standardization in the United States is based on the establishment of a national reference assigned\\u000a with a biological potency unit to which manufacturers’ products are compared using validated relative potency assays. This\\u000a ensures, at least with standardized allergen vaccines,

Robert E. Esch

2006-01-01

318

37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.  

Code of Federal Regulations, 2013 CFR

...patent term extension for a human drug, antibiotic drug or human biological product...patent term extension for a human drug, antibiotic drug or human biological product...750 that a patent for a human drug, antibiotic drug or human biological...

2013-07-01

319

Sustainable production of biologically active molecules of marine based origin.  

PubMed

The marine environment offers both economic and scientific potential which are relatively untapped from a biotechnological point of view. These environments whilst harsh are ironically fragile and dependent on a harmonious life form balance. Exploitation of natural resources by exhaustive wild harvesting has obvious negative environmental consequences. From a European industry perspective marine organisms are a largely underutilised resource. This is not due to lack of interest but due to a lack of choice the industry faces for cost competitive, sustainable and environmentally conscientious product alternatives. Knowledge of the biotechnological potential of marine organisms together with the development of sustainable systems for their cultivation, processing and utilisation are essential. In 2010, the European Commission recognised this need and funded a collaborative RTD/SME project under the Framework 7-Knowledge Based Bio-Economy (KBBE) Theme 2 Programme 'Sustainable culture of marine microorganisms, algae and/or invertebrates for high value added products'. The scope of that project entitled 'Sustainable Production of Biologically Active Molecules of Marine Based Origin' (BAMMBO) is outlined. Although the Union is a global leader in many technologies, it faces increasing competition from traditional rivals and emerging economies alike and must therefore improve its innovation performance. For this reason innovation is placed at the heart of a European Horizon 2020 Strategy wherein the challenge is to connect economic performance to eco performance. This article provides a synopsis of the research activities of the BAMMBO project as they fit within the wider scope of sustainable environmentally conscientious marine resource exploitation for high-value biomolecules. PMID:23563183

Murray, Patrick M; Moane, Siobhan; Collins, Catherine; Beletskaya, Tanya; Thomas, Olivier P; Duarte, Alysson W F; Nobre, Fernando S; Owoyemi, Ifeloju O; Pagnocca, Fernando C; Sette, L D; McHugh, Edward; Causse, Eric; Pérez-López, Paula; Feijoo, Gumersindo; Moreira, Ma T; Rubiolo, Juan; Leirós, Marta; Botana, Luis M; Pinteus, Susete; Alves, Celso; Horta, André; Pedrosa, Rui; Jeffryes, Clayton; Agathos, Spiros N; Allewaert, Celine; Verween, Annick; Vyverman, Wim; Laptev, Ivan; Sineoky, Sergei; Bisio, Angela; Manconi, Renata; Ledda, Fabio; Marchi, Mario; Pronzato, Roberto; Walsh, Daniel J

2013-04-03

320

Milk production change following clinical mastitis and reproductive performance compared among J5 vaccinated and control dairy cattle.  

PubMed

Naturally occurring cases of bovine clinical mastitis (CM) were studied among J5 vaccinates and controls on 3 commercial dairy farms. Milk production change and reproductive performance following CM were compared between the 2 groups. Among 306 controls and 251 vaccinates, there were 221 new cases of CM affecting 120 cows; 437 lactations never had a case of CM. Environmental pathogens made up 90% (159/176) of etiologic agents isolated. Change in daily milk production following CM was associated with J5 vaccination, days in milk (DIM) at onset of CM, and herd effect as well as each 2-way interaction between the 3 factors. The adjusted daily milk for 21 d following CM was 7.6 kg greater among J5 vaccinates than controls; however, this protective effect of vaccination waned with increasing DIM at onset of CM. A mixed linear model with autoregressive order 1 [AR(1)] correlation structure estimated the daily milk production of any cow (whether or not she had CM) on a given DIM. Cows with CM caused by nonagalactiae streptococci, Staphylococcus aureus, Escherichia coli, or Klebsiella lost significant daily milk production for the entire lactation relative to nonmastitic cows. Another mixed linear model for only coliform CM cases (E. coli, Klebsiella, and Enterobacter) within the first 50 DIM showed milk loss for 21 d following coliform CM to be significantly less for J5 vaccinates than for controls, by 6 to 15 kg per day. Cows were significantly less likely to become pregnant if they had CM caused by E. coli (42% pregnant) or Streptococcus spp. (38% pregnant), whereas 78% (342/437) of cows with no mastitis conceived. Days open (number of days from calving until pregnancy) averaged 131 d for cows with no CM and 162 d for cows that had at least one case of CM. Days until conception, days until last breeding, days open, times bred, and percentage of cows pregnant by 200 DIM were not changed with J5 vaccination. Nonetheless, an important benefit of the use of J5 bacterin appears to be reduction of the loss of daily milk production following CM, whether all cases or only those caused by coliform bacteria were considered. PMID:18832209

Wilson, D J; Grohn, Y T; Bennett, G J; González, R N; Schukken, Y H; Spatz, J

2008-10-01

321

WHO Expert Committee on biological standardization.  

PubMed

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on quality, safety and efficacy of live attenuated rotavirus vaccines; DNA vaccines; a biosafety risk assessment for production and quality control of human influenza pandemic vaccines; recommendations for inactivated rabies vaccines produced in cell substrates and embryonated eggs; for whole cell pertussis vaccine; and for production, control and regulation of human plasma for fractionation. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances. PMID:18314862

2007-01-01

322

First Self-Adjuvant Multicomponent Potential Vaccine Candidates by Tethering of Four or Eight MUC1 Antigenic Immunodominant PDTRP Units on a Calixarene Platform: Synthesis and Biological Evaluation.  

PubMed

MUC1 protein overexpressed in human epithelial carcinoma is a target in development of novel anticancer vaccines. Multiple units of immunodominant B-cell epitope PDTRP MUC1 core sequence were conjugated to calix[4,8]arene platforms containing TLR2 ligand, to produce two novel anticancer self-adjuvant vaccine candidates. The immunogenicity of the synthetic constructs was investigated by immunization of mice in vivo. ELISA assay evidenced that the vaccine candidates stimulate anti MUC1 IgG antibody production (major for the octavalent construct) and no additive effect but a multivalency effect was observed when compared to an analogous monovalent. Octa- and tetravalent constructs lacking in PDTRP peptide moieties did not show anti MUC1 IgG antibody production in mice. The antibodies induced by the synthesized constructs are able to recognize the MUC1 structures present on MCF7 tumor cells. The results display that calixarenes are convenient platforms for building multicomponent self-adjuvant vaccine constructs promising as immunotherapeutic anticancer agents. PMID:24041198

Geraci, Corrada; Consoli, Grazia M L; Granata, Giuseppe; Galante, Eva; Palmigiano, Angelo; Pappalardo, Maria; Di Puma, Salvatore D; Spadaro, Angelo

2013-09-16

323

Changes in TNF and IL-6 production after diphtheria toxoid vaccination: drug modulation of the cytokine levels  

PubMed Central

The effect of vaccination with diphtheria toxoid (AD-M) on TNF and IL-6 production has been studied in humans. In the present study it was demonstrated that immunization with AD-M resulted in changes of in vitro TNF and IL-6 production by peripheral blood mononuclear cells. TNF release was suppressed but IL-6 production was stimulated. On the other hand, serum levels of TNF were markedly increased over a period of 3 weeks. It was also demonstrated that the postvaccinal cytokine production disturbances may be corrected by pretreatment with a new synthetic hexapeptid (Imunofan®). It is possible that the imunofan treatment could prevent some postvaccinal complications.

Bliacher, M. S.; Danilina, A. V.; Kalashnikova, E. A.; Lopatina, T. K.; Fedorova, I. M.

1996-01-01

324

Immunobiology of influenza vaccines.  

PubMed

Vaccination is the primary strategy for prevention and control of influenza. The surface hemagglutinin (HA) protein of the influenza virus contains two structural elements (head and stalk) that differ in their potential utility as vaccine targets. The head of the HA protein is the primary target of antibodies that confer protective immunity to influenza viruses. The underlying health status, age, and gene polymorphisms of vaccine recipients and, just as importantly, the extent of the antigenic match between the viruses in the vaccine and those that are circulating modulate influenza vaccine protection. Vaccine adjuvants and live attenuated influenza vaccine improve the breadth of immunity to seasonal and pandemic virus strains. Eliciting antibodies against the conserved HA stem region that cross-react with HAs within influenza virus types or subtypes would allow for the development of a universal influenza vaccine. The highly complex network of interactions generated after influenza infection and vaccination can be studied with the use of systems biology tools, such as DNA microarray chips. The use of systems vaccinology has allowed for the generation of gene expression signatures that represent key transcriptional differences between asymptomatic and symptomatic host responses to influenza infection. Additionally, the use of systems vaccinology tools have resulted in the identification of novel surrogate gene markers that are predictors of the magnitude of host responses to vaccines, which is critical to both vaccine development and public health. Identifying associations between variations in vaccine immune responses and gene polymorphisms is critical in the development of universal influenza vaccines. PMID:23381315

Gomez Lorenzo, Margarita M; Fenton, Matthew J

2013-02-01

325

Vaccines in a hurry  

Microsoft Academic Search

Preparing populations for health threats, including threats from new or re-emerging infectious diseases is recognised as an important public health priority. The development, production and application of emergency vaccinations are the important measures against such threats. Vaccines are cost-effective tools to prevent disease, and emergency vaccines may be the only means to prevent a true disaster for global society in

Christian Søborg; Kåre Mølbak; T. Mark Doherty; Peter Ulleryd; Tim Brooks; Claudine Coenen; Ben van der Zeijst

2009-01-01

326

Aluminum salts in vaccines--US perspective.  

PubMed

Aluminum in the form of aluminum hydroxide, aluminum phosphate or alum has been commonly used as an adjuvant in many vaccines licensed by the US Food and Drug Administration. Chapter 21 of the US Code of Federal Regulations [610.15(a)] limits the amount of aluminum in biological products, including vaccines, to 0.85 mg/dose. The amount of aluminum in vaccines currently licensed in the US ranges from 0.85-0.125 mg/dose. Clinical studies have demonstrated that aluminum enhances the antigenicity of some vaccines such as diphtheria and tetanus toxoids. Moreover, aluminum-adsorbed diphtheria and tetanus toxoids are distinctly more effective than plain fluid toxoids for primary immunization of children. There is little difference between plain and adsorbed toxoids for booster immunization. Aluminum adjuvants have a demonstrated safety profile of over six decades; however, these adjuvants have been associated with severe local reactions such as erythema, subcutaneous nodules and contact hypersensitivity. PMID:12184360

Baylor, Norman W; Egan, William; Richman, Paul

2002-05-31

327

Acellular pertussis vaccines in China.  

PubMed

In China, whole-cell pertussis (Pw) vaccines were produced in the early 1960s and acellular pertussis (Pa) vaccines were introduced in 1995. Pa vaccines have now almost completely replaced Pw vaccines in the national immunization program. To strengthen the regulation of vaccines used in China, a vaccine lot release system was established in 2001 and Pa vaccines have been included in the system since 2006. This paper mainly described the current status of production and the quality control measures in place for Pa vaccines; and analyses quality control test data accumulated between 2006 and 2010. PMID:23084855

Wang, Lichan; Lei, Dianliang; Zhang, Shumin

2012-10-19

328

9 CFR 118.3 - Movement of detained biological products; Termination of detention.  

Code of Federal Regulations, 2013 CFR

...ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DETENTION; SEIZURE AND CONDEMNATION § 118.3 Movement of detained biological products; Termination...

2013-01-01

329

Regulatory cytokine production stimulated by DNA vaccination against an altered form of glutamic acid decarboxylase 65 in nonobese diabetic mice.  

PubMed

Nonobese diabetic (NOD) mice develop a T-cell dependent autoimmune form of diabetes, in which glutamic acid decarboxylase 65 (GAD65) is an important islet target antigen. Intramuscular DNA vaccination with a plasmid encoding native GAD65 (a cytosolic antigen) did not significantly alter the incidence of diabetes, but vaccination against an altered form of GAD65 with a signal peptide (spGAD), which is secreted in vitro, was protective. The preventive effect was further enhanced by repeated injections of the spGAD plasmid. Following DNA injection into muscle GAD65 was expressed for several months, and this was not accompanied by an inflammatory response. Immunization against GAD65 was not associated with substantial alterations in cytokine production by splenic lymphocytes stimulated with immunogenic GAD65 peptides. In contrast, spGAD induced increased secretion of both interleukin 10 and interferon gamma and a striking decrease in the interferon gamma/interleukin 10 ratio in culture supernatants. Similarly, spGAD-immunized mice had higher serum interleukin 10 levels and lower serum interferon gamma levels than other groups, suggesting a systemic effect. In nondiabetic mice there was increased basal production of transforming growth factor beta(1), which was enhanced by antigenic stimulation. These alterations in regulatory cytokine production were apparent both early and late after the treatment was initiated. These findings suggest that DNA vaccination against spGAD protects NOD mice by increasing regulatory cytokine production. PMID:12682726

Glinka, Yelena; De Pooter, Renée; Croze, France; Prud'homme, Gérald J

2003-02-11

330

Analysis of the landscape of biologically-derived pharmaceuticals in Europe: Dominant production systems, molecule types on the rise and approval trends.  

PubMed

A thorough sort of the human drugs approved by the European Medicines Agency (EMA) between its establishment in 1995 until June 2012 is presented herein with a focus on biologically-derived pharmaceuticals. Over 200 (33%) of the 640 approved therapeutic drugs are derived from natural sources, produced via recombinant DNA technology, or generated through virus propagation. A breakdown based on production method, type of molecule and therapeutic category is presented. Current EMA approvals demonstrate that mammalian cells are the only choice for glycoprotein drugs, with Chinese hamster ovary cells being the dominant hosts for their production. On the other hand, bacterial cells and specifically Escherichia coli are the dominant hosts for protein-based drugs, followed by the yeast Saccharomyces cerevisiae. The latter is the dominant host for recombinant vaccine production, although egg-based production is still the main platform of vaccine provision. Our findings suggest that the majority of biologically-derived drugs are prescribed for cancer and related conditions, as well as the treatment of diabetes. The approval rate for biologically-derived drugs shows a strong upward trend for monoclonal antibodies and fusion proteins since 2009, while hormones, antibodies and growth factors remain the most populous categories. Despite a clear pathway for the approval of biosimilars set by the EMA and their potential to drive sales growth, we have only found approved biosimilars for three molecules. In 2012 there appears to be a slow-down in approvals, which coincides with a reported decline in the growth rate of biologics sales. PMID:23262060

Kyriakopoulos, Sarantos; Kontoravdi, Cleo

2012-12-20

331

76 FR 36019 - Amendments to Sterility Test Requirements for Biological Products  

Federal Register 2010, 2011, 2012, 2013

...FDA-2011-N-0080] Amendments to Sterility Test Requirements for Biological Products AGENCY...FDA) proposes to amend the sterility test requirements for biological products...appropriate and state-of- the-art test methods for assuring the safety of...

2011-06-21

332

77 FR 26162 - Amendments to Sterility Test Requirements for Biological Products  

Federal Register 2010, 2011, 2012, 2013

...FDA-2011-N-0080] Amendments to Sterility Test Requirements for Biological Products AGENCY...Administration (FDA) is amending the sterility test requirements for biological products...appropriate and state-of- the-art test methods for assuring the safety of...

2012-05-03

333

21 CFR 310.4 - Biologics; products subject to license control.  

Code of Federal Regulations, 2010 CFR

...2009-04-01 2009-04-01 false Biologics; products subject to license control. 310.4 Section 310.4 Food... General Provisions § 310.4 Biologics; products subject to license control. (a) If a drug has an...

2009-04-01

334

21 CFR 310.4 - Biologics; products subject to license control.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Biologics; products subject to license control. 310.4 Section 310.4 Food... General Provisions § 310.4 Biologics; products subject to license control. (a) If a drug has an...

2010-04-01

335

Volatilization and efflux of mercury from biologically productive ocean regions  

SciTech Connect

Mercury volatilization and oceanic evasion to the atmosphere were investigated in the tropical Pacific Ocean with emphasis on the biologically productive equatorial region. Further studies were conducted at two stations in the oligiotrophic North Pacific gyre, and in the estuarine mesocosms at the Marine Ecosystems Research Laboratory (MERL), University of Rhode Island. Dissolved gaseous Hg (DGM) in the tropical Pacific along 150/degree/ W at 4 stations ranged from 35-85 femtomoles per liter (fM) in surface waters and from 105-185 fM in deeper waters. Speciation experiments indicated that Hg/degree/was the dominant form in surface waters, while evidence for (CH/sub 3/)/sub 2/Hg was found at depth. In equatorial Pacific surface waters, DGM varied between 60 and 225 fM. Elemental Hg appears to comprise the major fraction of DGM. Elevated DGM concentrations corresponded with increased chlorophyll a levels and cooler, nutrient-rich waters. Surface waters of the equatorial Pacific were supersaturated with respect to Hg/degree/. Local Hg effluxes, estimated with a thin-film gas exchange model, were between 225 and 1050 pmoles/m/sup 2/ day. The annual Hg efflux from the equatorial Pacific, 1.6 /+-/ 1.3 /times/ 10/sup +6/ moles, was estimated at 4-5% of the total global Hg flux to the atmosphere. Dissolved gaseous Hg in the MERL mesocosms ranged from less than or equal to30 to 185 fM. In general, Hg/degree/ was the principal species, although (CH/sub 3/)/sub 2/minus// Hg was detected twice. Supersaturated levels of Hg/degrees/ corresponded with phytoplankton blooms of Cerataulina pelagica, Leptocylindrus danicus, Leptocylindrus mimimus, and Phaeocystis poucheti, suggesting that these phytoplankton could volatilize Hg in estuarine waters.

Kim, J.P.

1987-01-01

336

Volatilization and Efflux of Mercury from Biologically Productive Ocean Regions.  

NASA Astrophysics Data System (ADS)

Mercury volatilization and oceanic evasion to the atmosphere were investigated in the tropical Pacific Ocean with emphasis on the biologically productive equatorial region. Further studies were conducted at two stations in the oligiotrophic North Pacific gyre, and in the estuarine mesocosms at the Marine Ecosystems Research Laboratory (MERL), University of Rhode Island. Dissolved gaseous Hg (DGM) in the tropical Pacific along 150^circ W at 4 stations (10^circ N, 0^ circ, 5^circ S, 12^circ S) ranged from 35-85 femtomoles per liter (fM) in surface waters and from 105-185 fM in deeper waters (350-400 meters). Speciation experiments indicated that Hg^circ was the dominant form in surface waters, while evidence for (CH_3)_2Hg was found at depth. The increases of DGM with depth are consistent with a volatile Hg source in deeper waters. A significant correlation between DGM and apparent oxygen utilization (n = 23, r = 0.694) suggested bacterial methylation of Hg in the oxygen minimum zone. In equatorial Pacific surface waters (155-95 ^circ W), DGM varied between 60 and 225 fM. Elemental Hg appears to comprise the major fraction of DGM. Elevated DGM concentrations corresponded with increased chlorophyll a levels and cooler, nutrient-rich waters. These results suggest that phytoplankton might volatilize Hg in surface seawater or bacteria could produce Hg^circ in deeper waters which upwell to the sea surface. Surface waters of the equatorial Pacific were supersaturated with respect to Hg^circ (179-1769%). Local Hg effluxes, estimated with a thin-film gas exchange model, were between 225 and 1050 pmoles/m^2day. The anual Hg efflux from the equatorial Pacific, 1.6 +/- 1.3 times 10^{+6 } moles (megamoles), was estimated at 4-5% of the total global Hg flux to the atmosphere. When normalized to primary production, a yearly Hg efflux of 14 +/- 9 megamoles was predicted for the oceans. This is about 35% of the annual atmospheric Hg flux and is comparable to human-derived Hg emissions. Dissolved gaseous Hg in the MERL mesocosms ranged from <=q30 to 185 fM. In general, Hg^circ was the principal species, although (CH_3)_2Hg was detected twice. Supersaturated levels of Hg ^circ corresponded with phytoplankton blooms of Cerataulina pelagica, Leptocylindrus danicus, Leptocylindrus minimus, and Phaeocystis poucheti, suggesting that these phytoplankton could volatilize Hg in estuarine waters. Micro-flagellates may produce (CH_3) _2Hg. Mercury emanations from the mesocosms were estimated to be approximately 10% of the oceanic Hg effluxes to the atmosphere.

Kim, Jonathan Philip

337

[A kinetic study of gamma interferon production in herpes simplex virus-1 DNA prime-protein boost regimen comparing to DNA or subunit vaccination].  

PubMed

The vast majority of the world's population is infected with Herpes simplex virus (HSV). Although antiviral therapy can reduce the incidence of reactivation and asymptomatic viral shedding, and limit morbidity and mortality from active disease, it cannot cure infection. Therefore, the development of an effective vaccine is an important global health priority. In this study, the induction of IFN-gamma production was compared by different herpes simplex virus 1 (HSV1) vaccines. Glycoprotein D (gD1) as a major immunogenic HSV1 glycoprotein was chosen to our study. Balb/c mice were administered with DNA vaccine encoding gD1, subunit glycoprotein vaccine including insect cells infected by a gD1 recombinant Baculovirus, prime DNA vaccine boosted by subunit glycoprotein vaccine, inactivated KOS strain as a positive control, PcDNA3 plasmid and Sf9 cells as a negative control. Evaluation tests showed kinetics of IFN-gamma mRNA at 8, 16 and 32 hours after restimulation sharply decreased whereas, IFN-gamma protein is significantly increased. Our results revealed that at 14 days after immunization IFN-gamma secretion of stimulated cells in all of the vaccinate groups dramatically raised rather than secreted IFN-gamma levels in mice that were analyzed at 7 days after vaccination. In comparison to other groups; Prime-Boost immunization dramatically caused vigorous and prompt IFN-gamma production at 7 days after immunization and 8 hours after restimulation. PMID:19548528

Arefian, Ehsan; Bamdad, Taravat; Soleimanjahi, Hoorieh; Akhood, Mohamad Reza; Parsania, Masaoud; Ghaemi, Amir

338

Field efficacy of an inactivated bivalent influenza vaccine in a multi-site swine production system during an outbreak of systemic porcine circovirus associated disease  

PubMed Central

Swine influenza (SI) is a disease of significance for the swine industry, and vaccination is often recommended as a way to reduce its impact on production. The efficacy of SI vaccines is well established under experimental conditions, but information about field efficacy is scarce. The objective of this study was to evaluate the efficacy of a commercial inactivated bivalent (H1N1/H3N2) vaccine under conditions of natural exposure to a field SI variant. To accomplish our goal we used a randomized, blinded, field trial in 2 cohorts of finisher pigs in a multi-site swine production system located in southern Ontario. During the trial, this herd experienced an outbreak of porcine circovirus associated disease (PCVAD). The efficacy of the SI vaccine was assessed through its effect on average daily weight gain, and serological responses to SI over time. The effect of vaccination on pig growth was different in the 2 cohorts. Weight gain was higher in vaccinated pigs than in control pigs in Cohort 1, but was numerically higher for control pigs than for vaccinated pigs in Cohort 2. Vaccination against swine influenza, in a herd experiencing an outbreak of PCVAD, was of questionable value.

Poljak, Zvonimir; Dewey, Catherine E.; Martin, S. Wayne; Christensen, Jette; Friendship, Robert M.

2010-01-01

339

[Viruses as biological weapons].  

PubMed

The destruction made by nuclear, biological and chemical weapons used by governments and terrorist groups in the near history is posing anxiety and fear for human being. Rumour about the possible use of these agents leads to the development of serious negative effects on populations. Since there are no vaccine and therapy for most viral agents and cost of production as biological weapons is low, interest rate is rising for viruses. In this review, general characteristics, diagnosis, therapy and protective measures for viral agents such as variola virus, hemorrhagic fever viruses, encephalitis viruses, Hantaviruses and Nipah viruses, those can be used as biological weapon, have been summarized. PMID:16358499

Akçali, Alper

2005-07-01

340

Vaccines, Blood & Biologics  

Center for Biologics Evaluation and Research (CBER)

... Blood Bank Devices, Blood Donor Screening Tests. ... Use in Children and Adults, Tuberculin Testing. ... Adverse Event Reporting, HIV Home Test Kits. ... More results from www.fda.gov/biologicsbloodvaccines

341

Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report, Vol. 55, No. RR-3, March 24, 2006.  

National Technical Information Service (NTIS)

During spring 2005, two tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) products formulated for use in adolescents (and, for one product, use in adults) were licensed in the United States (BOOSTRIX, GlaxoSmithKline Biologi...

2006-01-01

342

To Vaccinate, or Not to Vaccinate That is the Question  

NSDL National Science Digital Library

The case was prompted by a newspaper story about a couple who refused on religious grounds to have their son vaccinated even though vaccination is a requirement for admission to the public schools. It explores the issues surrounding the necessity and consequences of vaccination.  The case is suitable for both non-majors and allied health biology courses.

Shapiro, Caren D.

2001-01-01

343

9 CFR 114.17 - Rebottling of biological products.  

Code of Federal Regulations, 2013 CFR

...mixed, and rebottled in new final containers. (b) The rebottled product shall be adequately identified...container samples of the product shall be conducted on new samples selected from the rebottled product (serial or...

2013-01-01

344

9 CFR 103.3 - Shipment of experimental biological products.  

Code of Federal Regulations, 2013 CFR

...AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND...imposed, especially in the case of products containing live organisms, when they are deemed necessary or advisable by the...

2013-01-01

345

9 CFR 103.3 - Shipment of experimental biological products.  

Code of Federal Regulations, 2010 CFR

...VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF...experimental product prepared, shipped and used. At the conclusion of field studies, results shall be obtained, summarized, and...

2009-01-01

346

9 CFR 103.3 - Shipment of experimental biological products.  

Code of Federal Regulations, 2010 CFR

...VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF...experimental product prepared, shipped and used. At the conclusion of field studies, results shall be obtained, summarized, and...

2010-01-01

347

Thermal Effects on Biological Production in Nutrient Rich Ponds.  

National Technical Information Service (NTIS)

Physical, chemical, and biological differences between two similar ponds were studied. One pond was heated to 5 C above ambient temperature, while the other served as a reference. Two hundred and fifty green sunfish, Lepomis cyanellus, were planted in eac...

H. Siewaert

1972-01-01

348

Biogas Production and Biogas Uses: Biological Principles and Process Technology.  

National Technical Information Service (NTIS)

The report abstracted focuses on the biological and chemical principles allowing both to optimize the fermentative process and to purify the gases produced and provide for an optimal combustion efficiency. Cold fermentation is one of the processes the stu...

A. Wellinger K. Egger K. Sutter

1985-01-01

349

Biological Templating and the Production of Functional Fibers.  

National Technical Information Service (NTIS)

Biology offers several advantages over traditional systems for the construction of novel materials. These include self-assembly, template-directed assembly, replication, molecular diversity, and the ability to screen and select from amidst this diversity....

A. Belcher C. Chiang C. M. Mello J. Gu

2006-01-01

350

Rapid and Scalable Plant-based Production of a Cholera Toxin B Subunit Variant to Aid in Mass Vaccination against Cholera Outbreaks  

PubMed Central

Introduction Cholera toxin B subunit (CTB) is a component of an internationally licensed oral cholera vaccine. The protein induces neutralizing antibodies against the holotoxin, the virulence factor responsible for severe diarrhea. A field clinical trial has suggested that the addition of CTB to killed whole-cell bacteria provides superior short-term protection to whole-cell-only vaccines; however, challenges in CTB biomanufacturing (i.e., cost and scale) hamper its implementation to mass vaccination in developing countries. To provide a potential solution to this issue, we developed a rapid, robust, and scalable CTB production system in plants. Methodology/Principal Findings In a preliminary study of expressing original CTB in transgenic Nicotiana benthamiana, the protein was N-glycosylated with plant-specific glycans. Thus, an aglycosylated CTB variant (pCTB) was created and overexpressed via a plant virus vector. Upon additional transgene engineering for retention in the endoplasmic reticulum and optimization of a secretory signal, the yield of pCTB was dramatically improved, reaching >1 g per kg of fresh leaf material. The protein was efficiently purified by simple two-step chromatography. The GM1-ganglioside binding capacity and conformational stability of pCTB were virtually identical to the bacteria-derived original B subunit, as demonstrated in competitive enzyme-linked immunosorbent assay, surface plasmon resonance, and fluorescence-based thermal shift assay. Mammalian cell surface-binding was corroborated by immunofluorescence and flow cytometry. pCTB exhibited strong oral immunogenicity in mice, inducing significant levels of CTB-specific intestinal antibodies that persisted over 6 months. Moreover, these antibodies effectively neutralized the cholera holotoxin in vitro. Conclusions/Significance Taken together, these results demonstrated that pCTB has robust producibility in Nicotiana plants and retains most, if not all, of major biological activities of the original protein. This rapid and easily scalable system may enable the implementation of pCTB to mass vaccination against outbreaks, thereby providing better protection of high-risk populations in developing countries.

Bennett, Lauren J.; Baldauf, Keegan J.; Kajiura, Hiroyuki; Fujiyama, Kazuhito; Matoba, Nobuyuki

2013-01-01

351

A proposal for an alternative quality control test procedure for inactivated vaccines against food-and-mouth disease virus.  

PubMed

Foot-and-mouth disease (FMD) control in Brazil includes a strict mandatory vaccination program with vaccines produced in certified laboratories subject to inspection by the Brazilian Ministry of Agriculture, Livestock, and Food Supply (MAPA). The FMD vaccine's potency is tested through antibodies titration against structural viral proteins in sera from cattle that have not had any exposure to food-and-mouth disease virus (FMDV), at 28 days post-vaccination. Biological product testing using large animals is expensive and unwieldy. Thus, alternative testing procedures using laboratory animals have been proposed for quality control of these products. Such biological methods for vaccine evaluation using animals from vivarium facilities can have a significant impact through reduced costs, easier handling, and shorter testing times. The present study was designed to access Balb/C mice's humoral immune responses to a FMDV experimental vaccine, the composition of which contains three virus serotypes of FMDV (O1 Campos, A24 Cruzeiro, and C3 Indaial). Balb/C mice were immunized at doses that were 5% and 10% of the vaccine volume administered in cattle. Immunized mice had their antibody titers probed at 14, 21, and 28 DPV (days post vaccination). The results obtained were compared to those previously known from cattle's immune responses to the FMDV vaccine. An adequate immune response to the vaccine was seen with 10% formulation at 21 DPV. The study results are encouraging and indicate that the mouse model can be used for quality control in experimental vaccine testing. PMID:23267841

Molin-Capeti, K C; Sepulveda, L; Terra, F; Torres-Pioli, M F; Costa-Casagrande, T; França, S C; Thomaz-Soccol, V

2012-12-23

352

IL-10 production differentially influences the magnitude, quality, and protective capacity of Th1 responses depending on the vaccine platform  

PubMed Central

The quality of a Th1 response can be a prospective correlate of vaccine-mediated protection against certain intracellular pathogens. Using two distinct vaccine platforms, we evaluate the influence of interleukin (IL) 10 production on the magnitude, quality, and protective capacity of CD4+ T cell responses in the mouse model of Leishmania major infection. Multiparameter flow cytometry was used to delineate the CD4+ T cell production of interferon (IFN) ?, IL-2, tumor necrosis factor (TNF), and IL-10 (or combinations thereof) after vaccination. Immunization with a high dose of adenovirus (ADV) expressing leishmanial proteins (MML-ADV) elicited a limited proportion of multifunctional IFN-?+IL-2+TNF+ Th1 cells, a high frequency of IL-10–producing CD4+ T cells, and did not protect against subsequent challenge. Surprisingly, in the absence of IL-10, there was no change in the magnitude, quality, or protective capacity of the Th1 response elicited by high-dose MML-ADV. In contrast, after immunization with MML protein and CpG (MML + CpG), IL-10 limited the production of IL-12 by DCs in vivo, thereby decreasing the generation of multifunctional Th1 cells. Consequently, three immunizations with MML + CpG were required for full protection. However, inhibiting IL-10 at the time of immunization enhanced the magnitude and quality of the Th1 response sufficiently to mediate protection after only a single immunization. Overall, we delineate distinct mechanisms by which vaccines elicit protective Th1 responses and underscore the importance of multifunctional CD4+ T cells.

Darrah, Patricia A.; Hegde, Sonia T.; Patel, Dipti T.; Lindsay, Ross W. B.; Chen, Linda; Roederer, Mario

2010-01-01

353

Use of Recombinant DNA Techniques for the Production of a More Effective Anthrax Vaccine.  

National Technical Information Service (NTIS)

The overall goal of the present research is to construct a safe and effective human anthrax vaccine using recombinant DNA techniques. During the course of this contract, we have isolated and characterized each of the Bacillus anthracis toxin genes. Althou...

D. L. Robertson

1988-01-01

354

Gardasil(R) - The New HPV Vaccine: The Right Product, the Right Time? A Commentary  

PubMed Central

The federal and provincial governments have undertaken a universal immunization program to protect school-aged girls against cervical cancer using the new human papillomavirus vaccine Gardasil®. While the vaccine appears to be effective and safe, there are a number of important unanswered questions regarding it and the effects of the immunization program. Here we briefly review key literature about the vaccine and then use the Erickson criteria, which offer an evidence basis for decision-making regarding national immunization strategies, to evaluate whether the program is congruent with sound public health policy. Our analysis of the national decision to recommend and fund a vaccination program using Gardasil® raises significant questions about the basis for this program.

Lexchin, Joel; Arya, Neil; Singh, Sonal

2010-01-01

355

Public vaccine manufacturing capacity in the Latin American and Caribbean region: current status and perspectives.  

PubMed

The vaccine global market is currently growing at a rate of 16.52%. Nowadays the vaccine manufacturing industry is limited in the sense that not all vaccine manufacturers have the capacity to execute all the steps necessary to produce a successful product. The biological variation inherent to vaccine manufacturing and the initial investment required to bring a vaccine to the market are some of the factors that discourage vaccine manufacturing initiatives. Given the current global context in vaccine innovation and production, and the increasing participation of vaccine manufacturers from developing countries in global markets, this paper aims to review vaccine manufacturing capacity in Latin American and Caribbean (LAC) countries with specific focus on trends in national or public sector manufacturing, presenting current challenges and future opportunities for the sector in meeting national and regional (LAC) needs. Despite the overall low vaccine manufacturing capacity reported within the LAC region within this paper, it is considered that the relatively high and concentrated capacity that exists within a number of countries, combined with political commitment of all countries within the Region, can provide the necessary platform for the continued development of capacity in vaccine development and manufacture within LAC. PMID:22033155

Cortes, Maria de los Angeles; Cardoso, Daniel; Fitzgerald, James; DiFabio, Jose Luis

2011-10-26

356

Smallpox Vaccine, Dried, Calf Lymph Type  

Center for Biologics Evaluation and Research (CBER)

... Smallpox Vaccine, Dried, Calf Lymph Type. -. Product. Dryvax Wyeth Pharmaceuticals, Inc. -. Contact FDA. (800) 835-4709. ... More results from www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts

357

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM ...  

Center for Biologics Evaluation and Research (CBER)

... Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM 197 Protein). -. Product. Prevnar 13 Wyeth Pharmaceuticals, Inc. -. Contact FDA. ... More results from www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts

358

A recombinant vaccine against hydatidosis: production of the antigen in Escherichia coli  

Microsoft Academic Search

A commercial process was developed for producing a recombinant vaccine against hydatidosis in farm animals. The vaccine antigen\\u000a consisting of a surface protein of the oncospheres of the hydatid worm (Echinococcus granulosus), was produced as inclusion bodies in Escherichia coli. Fed-batch cultures of E. coli using Terrific broth in stirred bioreactors at 37°C, pH 7.0, and a dissolved oxygen level of

Daniel Manderson; Robert Dempster; Yusuf Chisti

2006-01-01

359

Production of a Particulate Hepatitis C Vaccine Candidate by an Engineered Lactococcus lactis Strain?  

PubMed Central

Vaccine delivery systems based on display of antigens on bioengineered bacterial polyester inclusions can stimulate cellular immune responses. The food-grade Gram-positive bacterium Lactococcus lactis was engineered to produce spherical polyhydroxybutyrate (PHB) inclusions which abundantly displayed the hepatitis C virus core (HCc) antigen. In mice, the immune response induced by this antigen delivery system was compared to that induced by vaccination with HCc antigen displayed on PHB beads produced in Escherichia coli, to PHB beads without antigen produced in L. lactis or E. coli, or directly to the recombinant HCc protein. Vaccination site lesions were minimal in all mice vaccinated with HCc PHB beads or recombinant protein, all mixed in the oil-in-water adjuvant Emulsigen, while vaccination with the recombinant protein in complete Freund's adjuvant produced a marked inflammatory reaction at the vaccination site. Vaccination with the PHB beads produced in L. lactis and displaying HCc antigen produced antigen-specific cellular immune responses with significant release of gamma interferon (IFN-?) and interleukin-17A (IL-17A) from splenocyte cultures and no significant antigen-specific serum antibody, while the PHB beads displaying HCc but produced in E. coli released IFN-? and IL-17A as well as the proinflammatory cytokines tumor necrosis factor alpha (TNF-?) and IL-6 and low levels of IgG2c antibody. In contrast, recombinant HCc antigen in Emulsigen produced a diverse cytokine response and a strong IgG1 antibody response. Overall it was shown that L. lactis can be used to produce immunogenic PHB beads displaying viral antigens, making the beads suitable for vaccination against viral infections.

Parlane, Natalie A.; Grage, Katrin; Lee, Jason W.; Buddle, Bryce M.; Denis, Michel; Rehm, Bernd H. A.

2011-01-01

360

Combating high-priority biological agents: What to do with drug-allergic patients and those for whom vaccination is contraindicated?  

PubMed

The threat of bioterrorism continues to be a very real one. Regularly, there are news stories on bioterrorism-related topics: What biologic weapons will our enemies likely use to attack the United States? How prepared is our country to successfully counter such attacks? Although these critical questions are being addressed by the leaders of our country, allergists-immunologists, too, will have to grapple with difficult questions during these uncertain and frightening times. We care for a special group of patients with various allergic and immunologic disorders. Some of our patients have immunodeficiency disorders that might preclude them from receiving life-saving vaccines. Our patients with drug allergies are fearful that should they become infected with a biologic agent, they will not be able to receive appropriate treatment. In this article we focus on the various vaccine-related and antibiotic-related adverse effects that the allergist-immunologist might see during treatment of infections caused by Category A agents. Where possible, potential management approaches are outlined. PMID:14564343

Gruchalla, Rebecca S; Jones, James

2003-10-01

361

Understanding Vaccines: What They Are How They Work  

NSDL National Science Digital Library

This is a PDF booklet providing information on vaccines including how they prevent disease, how they are developed and researched, and what the future holds for vaccines in production. Benefits of vaccines, and specific vaccine types are discussed.

2003-07-01

362

WHO Expert Committee on Biological Standardization.  

PubMed

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on the production and quality control of candidate tetravalent dengue virus vaccines and recommendations for the preparation, characterization and establishment of international and other biological reference standards. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances. PMID:17274191

2006-01-01

363

[New vaccination strategies].  

PubMed

Pasteur put vaccination on an empiric and experimental basis during the 1880s, and vaccine development proceeded slowly until the second World War. During this period live vaccines against bacterial and viral diseases were developed by attenuation through passage in animals and killed microbes were inactivated without destroying their immunogenicity. Moreover, knowledge of bacterial toxins and polysaccharides permitted the development of new vaccines for several epidemic diseases. At the beginning of the third century of vaccination, classical methods are still providing new vaccines, but molecular biology and genetic engineering have begun to influence vaccine development. In addition, for the first time basic immunology is contributing to the domain of vaccinology. Thus, the current trends in vaccine development are as follows: reassortment of segmented genomes, attenuated strains recombined with genes from pathogens, vectors carrying foreign genes, replication-defective particles, DNA plasmids, and reverse vaccinology, among others. Also, new methods of vaccine delivery besides injection will be used and new adjuvants will be added to vaccines in order to stimulate specific responses. The future of vaccination is promising. PMID:18819697

Plotkin, Stanley A

2008-03-01

364

9 CFR 113.303 - Bluetongue Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.303 Bluetongue Vaccine...Bluetongue Vaccine shall be prepared from virus-bearing cell culture fluids....

2013-01-01

365

9 CFR 113.313 - Measles Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.313 Measles Vaccine. Measles Vaccine shall be prepared from virus-bearing cell culture fluids. Only...

2013-01-01

366

9 CFR 101.3 - Biological products and related terms.  

Code of Federal Regulations, 2013 CFR

...Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE...number assigned by Animal and Plant Health Inspection Service to...with or without the unevaluated growth products, which has been inactivated...sterile, antigenic toxin or toxic growth product, which has...

2013-01-01

367

Influences of F-strain Mycoplasma gallisepticum vaccine on productive and reproductive performance of commercial parent broiler chicken breeders on a multi-age farm.  

PubMed

The influences of F-strain Mycoplasma gallisepticum (FMG) vaccine inoculation during the pullet period on the subsequent productive and reproductive performance of parent broiler chicken breeders on a multi-age farm were evaluated. Three thousand breeders were randomly divided into 2 treatment groups that were either vaccinated with FMG (FMG-vaccinated group) or not vaccinated with FMG (FMG-free group). Body weight and egg production were determined through approximately 50 wk of age. Egg weight and feed conversion was determined at 26, 32, 35, 38, and 43 wk of age. Egg quality parameters, including eggshell strength, egg-specific gravity, egg shape index, blood-meat spots, Haugh unit score, eggshell thickness, yolk:albumen ratio, percentage yolk, albumen and eggshell weights, and percentage fertility, hatchability, and second-quality chicks were determined at 26, 32, and 43 wk of age. Air sacs were examined and lesions were scored at 20, 32, and 50 wk of age. The number of mature ovarian follicles, histologies of ovary, and lengths, and histologies of the infundibulum, magnum, isthmus, uterus, and vagina were determined. In the present study, an increase in egg production of broiler breeder hens in the FMG-vaccinated group during peak of lay was compared with the FMG-free group. Feed conversion of hens in the FMG-vaccinated group was significantly less at 32, 35, 38, and 43 wk of age. Eggs from hens in the FMG-vaccinated group had a significantly higher Haugh units score at 26 wk of age and had a significantly higher eggshell thickness and lower incidence of blood-meat spots at 32 wk. Hatching eggs from hens in the FMG-vaccinated group had a significantly higher hatchability. The mean lesion score of air-sac lesion of birds in the FMG-vaccinated group was significantly less than FMG-vaccinated group. Uteruses of hens in the FMG-vaccinated group had a significantly longer length compared with the FMG-free group at 32 wk of age. The results indicate that inoculation of commercial parent broiler chicken breeders with the FMG vaccine before laying may prevent infection by field M. gallisepticum, and facilitate productive and reproductive performance. PMID:23687149

Liu, J J; Ding, L; Wei, J Z; Li, Y

2013-06-01

368

Production and efficacy of an Aeromonas hydrophila recombinant S-layer protein vaccine for fish.  

PubMed

A recombinant protein for the S-layer protein of Aeromonas hydrophila was produced and its ability to protect common carp Cyprinus carpio L. against six virulent isolates of A. hydrophila was assessed. A group of 120 carp (30-40 g) were vaccinated intra-peritoneally with 0.1 ml of adjuvanted vaccine (30 microg protein per fish). Another group of 120 carp were injected with 0.1 ml of PBS-adjuvant mixture to serve as controls. Twenty fish from each group were challenged with each one of six virulent isolates of A. hydrophila 35 days post-vaccination. The fish were maintained in 12 separate tanks before terminating the experiment at 16 days post-challenge. The relative percentage survival (RPS) for the six isolates of A. hydrophila ranged from 56 to 87%. The difference in survival rate of fish challenged with four of the isolates was statistically significant in vaccinated fish compared to control fish, when analysed using a Chi-square test. The results of the study suggest that the recombinant S-layer protein of A. hydrophila could be useful as a vaccine antigen to protect fish against different isolates of this pathogenic bacterium. PMID:20307596

Poobalane, Saravanane; Thompson, Kim D; Ardó, László; Verjan, Noel; Han, Hyun-Ja; Jeney, Galina; Hirono, Ikuo; Aoki, Takashi; Adams, Alexandra

2010-03-20

369

Enhanced Assessment of the Health Status of Vaccine Protected Personnel At-Risk to Multiple Biowarfare Agents Using a Novel, Web-Based Clinical Data Management System (CDMS).  

National Technical Information Service (NTIS)

The Special Immunization Program (SIP) Clinic at the U. S. Army Medical Research Institute of Infectious Diseases (USAMRIID) provides investigational vaccines developed as potential biological defense products for Armed Forces personnel. These investigati...

M. J. McCreery J. E. Brown S. C. Mayer E. Boudreau M. Kortepeter

2004-01-01

370

Simultaneous determination of trace levels of ethylmercury and methylmercury in biological samples and vaccines using sodium tetra(n-propyl)borate as derivatizing agent.  

PubMed

Because of increasing awareness of the potential neurotoxicity of even low levels of organomercury compounds, analytical techniques are required for determination of low concentrations of ethylmercury (EtHg) and methylmercury (MeHg) in biological samples. An accurate and sensitive method has been developed for simultaneous determination of methylmercury and ethylmercury in vaccines and biological samples. MeHg and EtHg were isolated by acid leaching (H2SO4-KBr-CuSO4), extraction of MeHg and EtHg bromides into an organic solvent (CH2Cl2), then back-extraction into Milli-Q water. MeHg and EtHg bromides were derivatized with sodium tetrapropylborate (NaBPr4), collected at room temperature on Tenax, separated by isothermal gas chromatography (GC), pyrolysed, and detected by cold-vapour atomic fluorescence spectrometry (CV AFS). The repeatability of results from the method was approximately 5-10% for EtHg and 5-15% for MeHg. Detection limits achieved were 0.01 ng g-1 for EtHg and MeHg in blood, saliva, and vaccines and 5 ng g-1 for EtHg and MeHg in hair. The method presented has been shown to be suitable for determination of background levels of these contaminants in biological samples and can be used in studies related to the health effects of mercury and its species in man. This work illustrates the possibility of using hair and blood as potential biomarkers of exposure to thiomersal. PMID:17340078

Gibicar, Darija; Logar, Martina; Horvat, Nusa; Marn-Pernat, Andreja; Ponikvar, Rafael; Horvat, Milena

2007-03-06

371

Why Reduced Seed Production is Not Necessarily Translated Into Successful Biological Weed Control  

Microsoft Academic Search

Insects introduced as biological control agents of diffuse knapweed, Centaurea dif- fusa, primarily reduce seed production. Knapweed densities appear to be resilient to great- ly reduced seed production. We have used measurements of seedling density and survival, and production of seeds by flowering diffuse knapweed plants to develop functions for a model of knapweed populations. These simulations show that improved

J. H. MYERS; CHRISTOPHER RISLEY

372

21 CFR 610.53 - Dating periods for licensed biological products.  

Code of Federal Regulations, 2013 CFR

...Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed ......do Not applicable...do 1 year. Hepatitis B Vaccine 2 years at 2 to 8 °C Not applicable 3 years. Influenza Virus Vaccine 1 year ......do 18...

2013-04-01

373

An assessment of MODIS Collection 5 global land cover product for biological conservation studies  

Microsoft Academic Search

Global land cover is the characterizations of Earth's surface, and it has been recognized as key drivers of biodiversity changes. Most biological conservation studies are focused on using land cover data to study the pattern of biological environment. However, few studies considered the accuracy of land cover products, which may induce further errors. Ecologists should be aware of those problems

Lu Liang; Peng Gong

2010-01-01

374

9 CFR 113.52 - Requirements for cell lines used for production of biologics.  

Code of Federal Regulations, 2010 CFR

...APHIS. (c) The MCS and either each subculture of cells used to prepare a biological...batch. (d) The MCS and either each subculture used to prepare a biological product...If bacteria or fungi are found in a subculture, the subculture shall not be...

2009-01-01

375

9 CFR 113.52 - Requirements for cell lines used for production of biologics.  

Code of Federal Regulations, 2010 CFR

...APHIS. (c) The MCS and either each subculture of cells used to prepare a biological...batch. (d) The MCS and either each subculture used to prepare a biological product...If bacteria or fungi are found in a subculture, the subculture shall not be...

2010-01-01

376

Typhoid Vaccine  

MedlinePLUS

... around the world and kills about 200,000. Typhoid vaccine can prevent typhoid. ... Who should get typhoid vaccine and when?Routine typhoid vaccination is not recommended in the United States, but typhoid vaccine is recommended for: Travelers ...

377

Identification of a new reovirus causing substantial losses in broiler production in France, despite routine vaccination of breeders.  

PubMed

Numerous cases of tenosynovitis appeared in France causing high morbidity in free-range and standard broilers. The main clinical findings were lameness, stunting and non-uniform bodyweights. Although the natural mortality was low, the economic losses due to birds that had to be removed from the flock prematurely, downgrading of carcases and lower average weights at slaughter were substantial. Postmortem examinations, bacteriological, virological and serological examination confirmed the aetiology of avian orthoreovirus (ARV)-induced tenosynovitis. The isolated ARVs were analysed serologically and genetically. Sequencing of ?C RT-PCR products and phylogenetic analysis revealed a new type of ARV. The virus was not neutralised in serum neutralisation test using monovalent sera from vaccinated chickens. Together with the flock data, epidemiology of these recent reovirus outbreaks in France was reconstructed. It is concluded that these reovirus isolates differ serologically and genetically from the well described reovirus isolates used in commercial vaccines which were not capable of preventing the disease. The outbreaks resulted in substantial losses in broilers from vaccinated breeders. PMID:23636701

Troxler, S; Rigomier, P; Bilic, I; Liebhart, D; Prokofieva, I; Robineau, B; Hess, M

2013-05-01

378

Research toward Malaria Vaccines  

NASA Astrophysics Data System (ADS)

Malaria exacts a toll of disease to people in the Tropics that seems incomprehensible to those only familiar with medicine and human health in the developed world. The methods of molecular biology, immunology, and cell biology are now being used to develop an antimalarial vaccine. The Plasmodium parasites that cause malaria have many stages in their life cycle. Each stage is antigenically distinct and potentially could be interrupted by different vaccines. However, achieving complete protection by vaccination may require a better understanding of the complexities of B- and T-cell priming in natural infections and the development of an appropriate adjuvant for use in humans.

Miller, Louis H.; Howard, Russell J.; Carter, Richard; Good, Michael F.; Nussenzweig, Victor; Nussenzweig, Ruth S.

1986-12-01

379

37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.  

Code of Federal Regulations, 2013 CFR

37 Patents, Trademarks, and Copyrights 1 2013-07-01...2013-07-01 false Calculation of patent term extension for a veterinary biological product. 1.779 Section 1.779 Patents, Trademarks, and Copyrights...

2013-07-01

380

Microbiological validation of a new manufacturing complex for an injectable biological product.  

PubMed

The Raritan Biological Production Facility (RBPF) at Ortho Pharmaceutical Corporation, Raritan, NJ, is a unique facility designed and built exclusively for the production of a sterile, injectable biological product of murine monoclonal origin. This product is the first injectable monoclonal antibody product to be licensed by FDA's Center for Biologics-Evaluation and Research (CBER). Thus, Ortho's Biotechnology Division had a unique opportunity to work very closely with CBER throughout all aspects of facility design, construction and validation, including microbiological validation of the facility and its equipment. This paper will address how existing guidelines for pharmaceutical and sterile products were used to develop initial validation protocols for the different areas and applications within the facility, and how the data gathered were used, with the assistance of CBER, to develop operating specifications and monitoring programs, for the operations within the complex. PMID:1453278

Carroll, M C; Van Pala, M; Vollherbst, L

381

[Production and testing of a live lyophilized bivalent vaccine against Aujeszky's disease and erysipelas in swine].  

PubMed

A live freeze-dried bivaccine against swine erysipelas and Aujeszky's disease in pigs was produced, its antigen titers reaching 10(8) and 10(4.67) for the two components, respectively. The immunity conferred to the vaccinated pigs (so far as Aujeszky's disease is concerned) had an antibody titer of 1:4, and in sheep the titer was up to 1:16, these animals showing resistance at a control infection with 5000 LD50 per head. The vaccinated pigs likewise withstood a control infection with a mixed 24-48-hour broth culture of virulent strains causing swine erysipelas. PMID:941396

Vasilev, V; Stoev, I; Simeonov, S; Iotov, M; Kotsev, Ts

1976-01-01

382

Evaluation of the Modified ELISPOT Assay for Gamma Interferon Production in Cancer Patients Receiving Antitumor Vaccines  

PubMed Central

Frequencies of vaccine-responsive T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC) prior to and after administration of peptide-based vaccines in patients with cancer can be measured by limiting-dilution assays (LDA) or by ELISPOT assays. We have used a modified version of the ELISPOT assay to monitor changes in the frequency of gamma interferon (IFN-?)-producing T cells in a population of lymphocytes responding to a relevant peptide or a nonspecific stimulator, such as phorbol myristate acetate-ionomycin. Prior to its use for monitoring of patient samples, the assay was validated and found to be comparable to the LDA performed in parallel, using tumor-reactive cytolytic T-lymphocyte (CTL) lines. The sensitivity of the ELISPOT assay was found to be 1/100,000 cells, with an interassay coefficient of variation of 15%, indicating that it could be reliably used for monitoring of changes in the frequency of IFN-?-secreting responder cells in noncultured or cultured lymphocyte populations. To establish that the assay is able to detect the T-cell precursor cells responsive to the vaccine, we used CD8+ T-cell populations positively selected from PBMC of HLA-A2+ patients with metastatic melanoma, who were treated with dendritic cell-based vaccines containing gp100, MELAN-A/MART-1, tyrosinase, and influenza virus matrix peptides. The frequency of peptide-specific responder T cells ranged from 0 to 1/2,600 before vaccination and increased by at least 1 log unit after vaccination in two patients, one of whom had a clinical response to the vaccine. However, no increases in the frequency of peptide-responsive T cells were observed in noncultured PBMC or PBMC cultured in the presence of the relevant peptides after the melanoma patients enrolled in another trial were treated with the intramuscular peptide vaccine plus MF59 adjuvant. Thus, while the ELISPOT assay was found to be readily applicable to assessments of frequencies of CTL precursors of established CTL lines and ex vivo-amplified PBMC, its usefulness for monitoring of fresh PBMC in patients with cancer was limited. In many of these patients antitumor effector T cells are present at frequencies of lower than 1/100,000 in the peripheral circulation. Serial monitoring of such patients may require prior ex vivo amplification of specific precursor cells.

Asai, Tadao; Storkus, Walter J.; Whiteside, Theresa L.

2000-01-01

383

78 FR 60884 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

...at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Donald W. Jehn or Denise Royster at...

2013-10-02

384

Kinetic study of biological hydrogen production by anaerobic fermentation  

Microsoft Academic Search

The growth kinetics of hydrogen producing bacteria using three different substrates, namely sucrose, non-fat dry milk (NFDM), and food waste were investigated in dark fermentation through a series of batch experiments. The results showed that hydrogen production potential and hydrogen production rate increased with an increasing substrate concentration. The maximum hydrogen yields from sucrose, NFDM, and food waste were 234,

Wen-Hsing Chen; Shen-Yi Chen; Samir Kumar Khanal; Shihwu Sung

2006-01-01

385

Nitrous oxide from soil denitrification: factors controlling its biological production  

Microsoft Academic Search

Increasing concentrations of nitrate, nitrite, and molecular oxygen enhanced production of nitrous oxide relative to molecular nitrogen during dentrification in soils. Soil acidity interacted with nitrate to increase the ratio of nitrous oxide to molecular nitrogen. In response to anoxic conditions, nitrous oxide production initially increased but nitrous oxide was then consumed, a pattern which resulted from the sequential synthesis

M. K. Firestone; R. B. Firestone; J. M. Tiedje

1980-01-01

386

Biology Needs a Modern Assessment System for Professional Productivity  

ERIC Educational Resources Information Center

|Stimulated in large part by the advent of the Internet, research productivity in many academic disciplines has changed dramatically over the last two decades. However, the assessment system that governs professional success has not kept pace, creating a mismatch between modes of scholarly productivity and academic assessment criteria. In this…

McDade, Lucinda A.; Maddison, David R.; Guralnick, Robert; Piwowar, Heather A.; Jameson, Mary Liz; Helgen, Kristofer M.; Herendeen, Patrick S.; Hill, Andrew; Vis, Morgan L.

2011-01-01

387

Biology Needs a Modern Assessment System for Professional Productivity  

ERIC Educational Resources Information Center

Stimulated in large part by the advent of the Internet, research productivity in many academic disciplines has changed dramatically over the last two decades. However, the assessment system that governs professional success has not kept pace, creating a mismatch between modes of scholarly productivity and academic assessment criteria. In this…

McDade, Lucinda A.; Maddison, David R.; Guralnick, Robert; Piwowar, Heather A.; Jameson, Mary Liz; Helgen, Kristofer M.; Herendeen, Patrick S.; Hill, Andrew; Vis, Morgan L.

2011-01-01

388

Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars).  

PubMed

Reference Products and WHO International Standards/Reference Reagents have roles to play in the development and characterization of similar biological products (SBPs). However, these roles are distinct and non-interchangeable. The uses of these materials and their limitations are considered in this paper. PMID:21880508

Thorpe, Robin; Wadhwa, Meenu

2011-08-30

389

A quantitative analysis for the ADP-ribosylation activity of pertussis toxin: an enzymatic-HPLC coupled assay applicable to formulated whole cell and acellular pertussis vaccine products.  

PubMed

The majority of the biological effects of pertussis toxin (PT) are the result of a toxin-catalyzed transfer of an adenosine diphosphate-ribose (ADP-ribose) moiety from NAD(+)to the alpha-subunits of a subset of signal-transducing guanine-nucleotide-binding proteins (G-proteins). This generally leads to an uncoupling of the modified G-protein from the corresponding receptor and the loss of effector regulation. This assay is based on the PT S1 subunit enzymatic transfer of ADP-ribose from NAD to the cysteine moiety of a fluorescent tagged synthetic peptide homologous to the 20 amino acid residue carboxyl-terminal sequence of the alpha-subunit of the G(i3)protein. The tagged peptide and the ADP-ribosylated product were characterized by HPLC/MS and MS/MS for structure confirmation. Quantitation of this characterized ADP-ribosylated fluorescently tagged peptide was by HPLC fluorescence using Standard Addition methodology. The assay was linear over a five hr incubation period at 20 degrees C at PT concentrations between 0.0625 and 4.0 microg/ml and the sensitivity of the assay could be increased several fold by increasing the incubation time to 24 h. Purified S1 subunit of PT exhibited 68.1+/-10.1% of the activity of the intact toxin on a molar basis, whereas the pertussis toxin B oligomer, the genetically engineered toxoid, (PT-9K/129G), and several of the other components of the Bordetella pertussis organism possessed little (<0.6%) or no detectable ribosylation activity. Commonly used pertussis vaccine reference materials, US PV Lot #11, BRP PV 66/303, and BRP PV 88/522, were assayed by this method against Bordetella pertussis Toxin Standard 90/518 and demonstrated to contain, respectively, 0.323+/-0.007, 0.682+/-0.045, and 0.757+/-0.006 microg PT/ml (Mean+/-SEM) or in terms of microg/vial: 3.63, 4.09 and 4.54, respectively. A survey of several multivalent pertussis vaccine products formulated with both whole cell as well as acellular components indicated that products possessed a wide range of ribosylation activities. The pertussis toxin S1 subunit catalyzed ADP- ribosylation of the FAC-Galpha(i3)C20 peptide substrate and its subsequent quantitation by HPLC was demonstrated to be a sensitive and quantitative method for measuring intrinsic pertussis toxin activity. This methodology not only has the potential to be an alternative physicochemical method to replace existing bioassay methodology, but has the added advantage of being a universal method applicable to the assay of pertussis toxin in both whole cell and acellular vaccines as well as bulk and final formulated vaccine products. Acceptance of this method by regulatory agencies and industry as a credible alternative to existing methods would, however, require validation in an international collaborative study against the widely accepted bioassay methods. PMID:11580213

Cyr, T; Menzies, A J; Calver, J; Whitehouse, L W

2001-06-01

390

A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine.  

PubMed

Conventional influenza vaccine production methods have limitations due to their reliance on chicken eggs. We evaluated whether a mammalian cell-culture system could reliably produce an influenza vaccine with favourable tolerability and immunogenicity profiles. Adult subjects (n=1200; 18-60 years of age) were randomized (2:2:2:1) to receive either one of three lots of a cell-culture-derived influenza vaccine (CCIV) or an egg-based trivalent inactivated influenza vaccine (TIV). Safety and reactogenicity were assessed using solicited indicators for 7 days post-vaccination, all other adverse events (AEs) were recorded for 21 days post-vaccination, and all serious AEs and AEs necessitating a physician's visit, and/or resulting in subject's withdrawal from the study, were collected for up to 6 months post-vaccination. Antibody titres were measured by haemagglutination inhibition (HI) assay using egg-based viral antigens. All three lots of CCIV had similar safety and tolerability profiles, analogous to those of the TIV. Lot-to-lot consistency was statistically demonstrated through bioequivalence for immunogenicity. Antibody titres assessed at 6 months demonstrated good persistence. This Phase III trial is the first to demonstrate lot-to-lot bioequivalence of a CCIV and persistence of immunogenicity in comparison with a TIV. PMID:19666152

Ambrozaitis, Arvydas; Groth, Nicola; Bugarini, Roberto; Sparacio, Vittoria; Podda, Audino; Lattanzi, Maria

2009-08-08

391

Japanese Encephalitis Vaccine, Inactivated, Adsorbed  

Center for Biologics Evaluation and Research (CBER)

Text Version... Submission Type: Original Application Submission ID: 125280/0 Office: OVRR Product: Japanese Encephalitis Virus Vaccine Inactivated ... More results from www.fda.gov/downloads/biologicsbloodvaccines/vaccines

392

FDA and Cancer Vaccine Development  

Center for Biologics Evaluation and Research (CBER)

Text Version... lymphocytes… – Tissue engineered products, eg various ... Viral vectors and DNA vaccines ... Vector-based and DNA vaccines are attractive ... More results from www.fda.gov/downloads/biologicsbloodvaccines/newsevents

393

Developing vaccines against pandemic influenza.  

PubMed

Pandemic influenza presents special problems for vaccine development. There must be a balance between rapid availability of vaccine and the safeguards to ensure safety, quality and efficacy of vaccine. Vaccine was developed for the pandemics of 1957, 1968, 1977 and for the pandemic alert of 1976. This experience is compared with that gained in developing vaccines for a possible H5N1 pandemic in 1997-1998. Our ability to mass produce influenza vaccines against a pandemic threat was well illustrated by the production of over 150 million doses of 'swine flu' vaccine in the USA within a 3 month period in 1976. However, there is cause for concern that the lead time to begin vaccine production is likely to be about 7-8 months. Attempts to reduce this time should receive urgent attention. Immunogenicity of vaccines in pandemic situations is compared over the period 1968-1998. A consistent feature of the vaccine trials is the demonstration that one conventional 15 microg haemagglutinin dose of vaccine is not sufficiently immunogenic in naive individuals. Much larger doses or two lower doses are needed to induce satisfactory immunity. There is some evidence that whole-virus vaccines are more immunogenic than split or subunit vaccines, but this needs substantiating by further studies. H5 vaccines appeared to be particularly poor immunogens and there is evidence that an adjuvant may be needed. Prospects for improving the development of pandemic vaccines are discussed. PMID:11779397

Wood, J M

2001-12-29

394

Biochemical and biological characteristics of cross-reacting material 197 (CRM 197), a non-toxic mutant of diphtheria toxin: Use as a conjugation protein in vaccines and other potential clinical applications  

Microsoft Academic Search

The biochemical and biological characteristics of CRM197 are reviewed. Polysaccharide protein conjugate vaccines represent an important technological advancement that allowed for protection against dangerous diseases in vulnerable populations such as infants. The first carrier proteins, diphtheria and tetanus toxoids, were chosen in the context of an extensive body of information describing their immunogenicity and safety profiles in clinical use. These

Michael Bröker; Paolo Costantino; Lisa DeTora; E. David McIntosh; Rino Rappuoli

2011-01-01

395

Revaccination with Marek's Disease Vaccines Induces Productive Infection and Superior Immunity  

Microsoft Academic Search

The most common lymphoproliferative disease in chickens is Marek's disease (MD), which is caused by the oncogenic herpesvirus Marek's disease virus (MDV). The emergence of hypervirulent pathotypes of MDV has led to vaccine failures, which have become common and which have resulted in serious economic losses in some countries, and a revaccination strategy has been introduced in practice. The mechanism

Changxin Wu; Junji Gan; Qiao Jin; Chuangfu Chen; Ping Liang; Yantao Wu; Xuefen Liu; Li Ma; Fred Davison

2009-01-01

396

Production of a highly immunogenic subunit ISCOM vaccine against Bovine Viral Diarrhea Virus  

Microsoft Academic Search

Bovine Viral Diarrhea Virus (BVDV) is a major pathogen of cattle in most countries. The main reservoir of virus in herds are BVDV persistently infected animals, which arise as a result of infection of the bovine fetus early in gestation. The spread of virus to the unborn fetus may be prevented by vaccination of the dam. We describe in this

S. Kamstrup; L. Roensholt; M. Holm Jensen; K. Dalsgaard

1999-01-01

397

Diphtheria, Tetanus, and Pertussis (DTaP) Vaccine  

MedlinePLUS

Adacel® (as a combination product containing Diphtheria, Tetanus Toxoids, Acellular Pertussis Vaccine) ... Boostrix® (as a combination product containing Diphtheria, Tetanus Toxoids, Acellular Pertussis Vaccine)

398

9 CFR 113.3 - Sampling of biological products.  

Code of Federal Regulations, 2010 CFR

...sample of product, other than Marek's...request from the Animal and Plant Health Inspection...along with all other test reagents as...compartment set aside by the licensee...delivered to the Animal and Plant Health...

2009-01-01

399

Maximum entropy production principle in physics, chemistry and biology  

Microsoft Academic Search

The tendency of the entropy to a maximum as an isolated system is relaxed to the equilibrium (the second law of thermodynamics) has been known since the mid-19th century. However, independent theoretical and applied studies, which suggested the maximization of the entropy production during nonequilibrium processes (the so-called maximum entropy production principle, MEPP), appeared in the 20th century. Publications on

L. M. Martyushev; V. D. Seleznev

2006-01-01

400

Biological Hydrogen Production Using Chloroform-treated Methanogenic Granules  

Microsoft Academic Search

In fermentative hydrogen production, the low-hydrogen-producing bacteria retention rate limits the suspended growth reactor\\u000a productivity because of the long hydraulic retention time (HRT) required to maintain adequate bacteria population. Traditional\\u000a bacteria immobilization methods such as calcium alginate entrapment have many application limitations in hydrogen fermentation,\\u000a including limited duration time, bacteria leakage, cost, and so on. The use of chloroform-treated anaerobic

Bo Hu; Shulin Chen

2008-01-01

401

Overview of marker vaccine and differential diagnostic test technology  

Microsoft Academic Search

Recent advances in molecular biology, immunology, microbiology, genetics and microbial pathogenesis have lead to the development of a wide variety of new approaches for developing safer and more effective vaccines based on designs such as subunit vaccines, gene deleted vaccines, live vectored vaccines, and DNA mediated vaccines. Technology tools can be as basic as identifying naturally occurring strains with deletions

Louise M. Henderson

2005-01-01

402

Attenuated and replication-competent vaccinia virus strains M65 and M101 with distinct biology and immunogenicity as potential vaccine candidates against pathogens.  

PubMed

Replication-competent poxvirus vectors with an attenuation phenotype and with a high immunogenic capacity of the foreign expressed antigen are being pursued as novel vaccine vectors against different pathogens. In this investigation, we have examined the replication and immunogenic characteristics of two vaccinia virus (VACV) mutants, M65 and M101. These mutants were generated after 65 and 101 serial passages of persistently infected Friend erythroleukemia (FEL) cells. In cultured cells of different origins, the mutants are replication competent and have growth kinetics similar to or slightly reduced in comparison with those of the parental Western Reserve (WR) virus strain. In normal and immune-suppressed infected mice, the mutants showed different levels of attenuation and pathogenicity in comparison with WR and modified vaccinia Ankara (MVA) strains. Wide genome analysis after deep sequencing revealed selected genomic deletions and mutations in a number of viral open reading frames (ORFs). Mice immunized in a DNA prime/mutant boost regimen with viral vectors expressing the LACK (Leishmania homologue for receptors of activated C kinase) antigen of Leishmania infantum showed protection or a delay in the onset of cutaneous leishmaniasis. Protection was similar to that triggered by MVA-LACK. In immunized mice, both polyfunctional CD4(+) and CD8(+) T cells with an effector memory phenotype were activated by the two mutants, but the DNA-LACK/M65-LACK protocol preferentially induced CD4(+) whereas DNA-LACK/M101-LACK preferentially induced CD8(+) T cell responses. Altogether, our findings showed the adaptive changes of the WR genome during long-term virus-host cell interaction and how the replication competency of M65 and M101 mutants confers distinct biological properties and immunogenicity in mice compared to those of the MVA strain. These mutants could have applicability for understanding VACV biology and as potential vaccine vectors against pathogens and tumors. PMID:23596295

Sánchez-Sampedro, Lucas; Gómez, Carmen Elena; Mejías-Pérez, Ernesto; Pérez-Jiménez, Eva; Oliveros, Juan Carlos; Esteban, Mariano

2013-04-17

403

The effect of vaccination, ploidy and smolt production regime on pathological melanin depositions in muscle tissue of Atlantic salmon, Salmo salar L.  

PubMed

The presence of melanin in muscle fillets of farmed salmon represents a considerable quality problem for the salmon industry with major economic concerns. In this study, we have examined the presence of abnormal pigmentation in vaccinated versus unvaccinated Atlantic salmon, Salmo salar L., and evaluated possible differences between diploid and triploid fish. Furthermore, the impact of the smolt production regime at ambient (4.5 °C) versus elevated temperature (16 °C) was investigated. Pigmented muscle spots were analysed for the expression of genes involved in melanization (tyrosinase gene family) and immune-related response in addition to morphological investigations. The proportion of fish with intramuscular melanin deposits was not significantly different between vaccinated and unvaccinated fish, regardless of ploidy. However, an interaction between vaccination and smolt regime was shown, where smoltification at elevated temperature after vaccination increased the number of affected individuals compared with vaccination followed by simulated natural smoltification. Furthermore, there were overall more fish with melanin spots amongst the triploids compared with their diploid counterparts. Transcription of the tyrosinase gene family confirmed an onsite melanogenesis in all pigment spots. The histological examination and the expression of the immune-related genes revealed a chronic polyphasic myopathy that was not affected by vaccination, ploidy or smolt production regime. PMID:23646928

Larsen, H A S; Austbø, L; Nødtvedt, A; Fraser, T W K; Rimstad, E; Fjelldal, P G; Hansen, T; Koppang, E O

2013-05-01

404

WHO Expert Committee on Biological Standardization.  

PubMed

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains WHO Guidelines for the production, control and regulation of snake antivenom immunoglobulins and also an addendum to the WHO Recommendations for yellow fever vaccine. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances. PMID:22900409

2012-01-01

405

Emerging Vaccine Informatics  

PubMed Central

Vaccine informatics is an emerging research area that focuses on development and applications of bioinformatics methods that can be used to facilitate every aspect of the preclinical, clinical, and postlicensure vaccine enterprises. Many immunoinformatics algorithms and resources have been developed to predict T- and B-cell immune epitopes for epitope vaccine development and protective immunity analysis. Vaccine protein candidates are predictable in silico from genome sequences using reverse vaccinology. Systematic transcriptomics and proteomics gene expression analyses facilitate rational vaccine design and identification of gene responses that are correlates of protection in vivo. Mathematical simulations have been used to model host-pathogen interactions and improve vaccine production and vaccination protocols. Computational methods have also been used for development of immunization registries or immunization information systems, assessment of vaccine safety and efficacy, and immunization modeling. Computational literature mining and databases effectively process, mine, and store large amounts of vaccine literature and data. Vaccine Ontology (VO) has been initiated to integrate various vaccine data and support automated reasoning.

He, Yongqun; Rappuoli, Rino; De Groot, Anne S.; Chen, Robert T.

2010-01-01

406

Occurrence of suppurative lymphadenitis after a change of BCG vaccine  

Microsoft Academic Search

BCG vaccines are the oldest vaccines in use today, but the protective effect of the vaccination is still controversial. The risk of contracting tuberculosis is low compared with the possible complications after this vaccination. In Austria the formerly used BCG vaccine was not available in the required amount and another vaccine was released by the drug authorities. This product, with

P Hengster; J Schnapka; M Fille; G Menardi

1992-01-01

407

Biological validation of bio-engineered red blood cell productions.  

PubMed

The generation in vitro of cultured red blood cells (cRBC) could become an alternative to classical transfusion products. However, even when derived from healthy donors, the cRBC generated in vitro from hematopoietic stem cells may display alterations resulting from a poor controlled production process. In this context, we attempted to monitor the quality of the transfusion products arising from new biotechnologies. For that purpose, we developed an in vitro erythrophagocytosis (EP) test with the murine fibroblast cell line MS-5 and human macrophages (reference method). We evaluated 38 batches of cRBC, at the stage of reticulocyte, generated from CD34(+) cells isolated from placental blood or by leukapheresis. We showed that (i) the EP test performed with the MS-5 cell line was sensitive and can replace human macrophages for the evaluation of cultured cells. (ii) The EP tests revealed disparities among the batches of cRBC. (iii) The viability of the cells (determined by calcein-AM test), the expression of CD47 (antiphagocytosis receptor) and the externalization of phosphatidylserine (PS, marker of phagocytosis) were not critical parameters for the validation of the cRBC. (iv) Conversely, the cell deformability determined by ektacytometry was inversely correlated with the intensity of the phagocytic index. Assuming that the culture conditions directly influence the quality of the cell products generated, optimization of the production mode could benefit from the erythrophagocytosis test. PMID:23040561

Giarratana, Marie-Catherine; Marie, Tiffany; Darghouth, Dhouha; Douay, Luc

2012-10-04

408

Thimerosal in Vaccines Questions and Answers  

Center for Biologics Evaluation and Research (CBER)

... relationship between thimerosal-containing vaccines and autism, and that hypotheses generated to date concerning a biological mechanism for ... More results from www.fda.gov/biologicsbloodvaccines/vaccines/questionsaboutvaccines

409

Clinical Review: Hepatitis A Vaccine, Purified, Inactivated ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Subject: Final Clinical Review of Supplemental Biologics License Application for Hepatitis A vaccine, purified inactivated (STN 103606 VAQTA ... More results from www.fda.gov/downloads/biologicsbloodvaccines/vaccines

410

Vaccine Notices, Proposed and Final Rules  

Center for Biologics Evaluation and Research (CBER)

... Biologics Rules. Vaccines Proposed & Final Rules. -. Vaccine Notices, Proposed and Final Rules. We have recently redesigned the FDA Web site. ... More results from www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/actsrulesregulations

411

[Poliovirus vaccine].  

PubMed

To avoid the risk of vaccine-associated paralytic poliomyelitis (VAPP) and polio outbreaks due to circulating vaccine-derived polioviruses, an inactivated poliovirus vaccine (IPV) was introduced for routine immunization in a number of countries with a low risk of polio outbreaks. Currently, production and marketing of a standalone conventional IPV and two diphtheria-pertussis-tetanus-IPV (Sabin-derived IPV; sIPV) products have been submitted, and it is expected that the IPV products will be introduced in Japan in the autumn of 2012. At the same time, a decline in the OPV immunization rate became apparent in Japan due to serious public concerns about a remaining risk of VAPP and introduction of IPV in the near future. Therefore, the recent development of polio immunity gaps should be carefully monitored, and surveillance of suspected polio cases and laboratory diagnosis of polioviruses have to be intensified for the transition period from OPV to IPV in Japan. The development of sIPV is one of the most realistic options to introduce affordable IPV to developing countries. In this regard, further clinical studies on its efficacy, safety, and interchangeability of sIPV will be needed after the introduction of the sIPV products, which will be licensed in Japan for the first time in the world. PMID:23189825

Shimizu, Hiroyuki

2012-06-01

412

Perspectives and advances of biological H2 production in microorganisms.  

PubMed

The rapid development of clean fuels for the future is a critically important global challenge for two main reasons. First, new fuels are needed to supplement and ultimately replace depleting oil reserves. Second, fuels capable of zero CO2 emissions are needed to slow the impact of global warming. This review summarizes the development of solar powered bio-H2 production processes based on the conversion of photosynthetic products by fermentative bacteria, as well as using photoheterotrophic and photoautrophic organisms. The use of advanced bioreactor systems and their potential and limitations in terms of process design, efficiency, and cost are also briefly reviewed. PMID:16896600

Rupprecht, Jens; Hankamer, Ben; Mussgnug, Jan H; Ananyev, Gennady; Dismukes, Charles; Kruse, Olaf

2006-08-05

413

Combination biological and microwave treatments of used rubber products  

DOEpatents

A process and resulting product is provided in which a vulcanized solid particulate, such as vulcanized crumb rubber, has select chemical bonds altered by biotreatment with thermophillic microorganisms selected from natural isolates from hot sulfur springs. Following the biotreatment, microwave radiation is used to further treat the surface and to treat the bulk interior of the crumb rubber. The resulting combined treatments render the treated crumb rubber more suitable for use in new rubber formulations. As a result, larger loading levels and sizes of the treated crumb rubber can be used in new rubber mixtures and good properties obtained from the new recycled products.

Fliermans, Carl B. (Augusta, GA); Wicks, George G. (Aiken, SC)

2002-01-01

414

Is new always better than old?: The development of human vaccines for anthrax.  

PubMed

Anthrax is caused by a Gram-positive aerobic spore-forming bacillus called Bacillus anthracis. Although primarily a disease of animals, it can also infect man, sometimes with fatal consequences. As a result of concerns over the illicit use of this organism, considerable effort is focused on the development of therapies capable of conferring protection against anthrax. while effective concerns over the toxicity of the current vaccines have driven the development of second-generation products. Recombinant Protective Antigen (rPA), the nontoxic cell-binding component of anthrax lethal toxin, is the principal immunogen of the vaccines currently undergoing human clinical trials. While these new vaccines are likely to show reduced side effects they will still require multiple needle based dosing and the inclusion of the adjuvant alum which will make them expensive to administer and stockpile. To address these issues, researchers are seeking to develop vaccine formulations capable of stimulating rapid protection following needle-free injection which are stable at room temperature to facilitate stockpiling and mass vaccination programs. Recent concerns over the potential use of molecular biology to engineer vaccine resistant strains has prompted investigators to identify additional vaccine targets with which to extend the spectrum of protection conferred by rPA. While the injection of research dollars has seen a dramatic expansion of the anthrax vaccine field it is sobering to remember that work to develop the current second generation vaccines began around the time of the first gulf war. Almost two decades and millions of dollars later we still do not have a replacement vaccine and even when we do some argue that the spectrum of protection that it confers will not be as broad as the vaccine it replaces. If we are to respond effectively to emerging biological threats we need to develop processes that generate protective vaccines in a meaningful time frame and yield products in months not decades! PMID:19786839

Baillie, Leslie W

2009-12-09

415

Adjuvants for allergy vaccines  

PubMed Central

Allergen-specific immunotherapy is currently performed via either the subcutaneous or sublingual routes as a treatment for type I (IgE dependent) allergies. Aluminum hydroxide or calcium phosphate are broadly used as adjuvants for subcutaneous allergy vaccines, whereas commercial sublingual vaccines rely upon high doses of aqueous allergen extracts in the absence of any immunopotentiator. Adjuvants to be included in the future in products for allergen specific immunotherapy should ideally enhance Th1 and CD4+ regulatory T cell responses. Imunomodulators impacting dendritic or T cell functions to induce IL10, IL12 and IFN? production are being investigated in preclinical allergy models. Such candidate adjuvants encompass synthetic or biological immunopotentiators such as glucocorticoids, 1,25-dihydroxy vitamin D3, selected probiotic strains (e.g., Lactobacillus and Bifidobacterium species) as well as TLR2 (Pam3CSK4), TLR4 (monophosphoryl lipid A, synthetic lipid A analogs) or TLR9 (CpGs) ligands. Furthermore, the use of vector systems such as mucoadhesive particules, virus-like particles or liposomes are being considered to enhance allergen uptake by tolerogenic antigen presenting cells present in mucosal tissues.

Moingeon, Philippe

2012-01-01

416

Bacterial and other biological systems for polyester production  

Microsoft Academic Search

Poly(3-hydroxybutyric acid) and other structurally related aliphatic polyesters from bacteria, referred to as polyhydroxyalkanoic acids, form biodegradable thermoplastics and elastomers that are currently in use, or being considered for use, in industry, medicine, pharmacy and agriculture. At present, they are produced by microbial fermentations; in the future, production will also be possible by in vitro methods or by agriculture using

Alexander Steinbüchel; Bernd Füchtenbusch

1998-01-01

417

Biological Production of Methane from Lunar Mission Solid Waste: An Initial Feasibility Assessment  

Microsoft Academic Search

A preliminary assessment was made of the potential for biological production of methane from solid waste generated during an early planetary base mission to the moon. This analysis includes: 1) estimation of the amount of biodegradable solid waste generated, 2) background on the potential biodegradability of plastics given their significance in solid wastes, and 3) calculation of potential methane production

Richard Strayer; Jay Garland; Captain Janine

2008-01-01

418

Nutrient Management in Conservation Agriculture: A Biologically-Based Approach to Sustainable Production Intensification  

Microsoft Academic Search

Conservation Agriculture (CA) systems aim at enhancing soil health, productive capacity and function as a precursor to sustainable production intensification. Nutrient management in CA must be formulated within this framework of soil health which is a biologically-based phenomenon, the so called second paradigm approach which differs from the first which relies more on intensive tillage and application of external chemical

Amir Kassam; Theodor Friedrich

419

Escherichia coli heat-labile toxin subunit B fusions with Streptococcus sobrinus antigens expressed by Salmonella typhimurium oral vaccine strains: importance of the linker for antigenicity and biological activities of the hybrid proteins.  

PubMed Central

A set of vectors possessing the genes for aspartate semialdehyde dehydrogenase (asd) and the B subunit of the heat-labile enterotoxin of Escherichia coli (LT-B) has been developed. These vectors allow operon or gene fusions of foreign gene epitopes at the C-terminal end of LT-B. Two groups of vectors have been constructed with and without leader sequences to facilitate placing of the foreign antigen in different cell compartments. Two Streptococcus sobrinus genes coding for principal colonization factors, surface protein antigen A (SpaA), and dextranase (Dex), have been fused into the 3' end of the LT-B gene. Resulting protein fusions of approximately 120 to 130 kDa are extremely well recognized by antibodies directed against both SpaA and Dex as well as against LT-B domains and retain the enzymatic activity of dextranase and the biological activity of LT-B in that they bind to GM1 gangliosides. Maximum antigenicity was obtained with the vector possessing an intervening linker of at least six amino acids with two proline residues. Some of the fusion proteins also exhibited another property of LT-B in that they were exported into the periplasm where they oligomerized. LT-B-SpaA and LT-B-Dex hybrid proteins are expressed stably and at a high level in avirulent Salmonella typhimurium vaccine strains which are being used to investigate their immunogenicity and types of induced immune responses. The fusion vectors will also be useful for production and purification of LT-B fusion antigens to be used and evaluated in other vaccine compositions. Images

Jagusztyn-Krynicka, E K; Clark-Curtiss, J E; Curtiss, R

1993-01-01

420

FDA Alerts Health Care Professionals about Sterile Products ...  

Center for Drug Evaluation (CDER)

... is working closely with the Centers for Disease Control and Prevention ... of human and veterinary drugs, vaccines and other biological products for ... More results from www.fda.gov/drugs/drugsafety

421

Production of influenza H1N1 vaccine from MDCK cells using a novel disposable packed-bed bioreactor.  

PubMed

A process for human influenza H1N1 virus vaccine production from Madin-Darby canine kidney (MDCK) cells using a novel packed-bed bioreactor is described in this report. The mini-bioreactor was used to study the relationship between cell density and glucose consumption rate and to optimize the infection parameters of the influenza H1N1 virus (A/New Caledonia/20/99). The MDCK cell culture and virus infection were then monitored in a disposable perfusion bioreactor (AmProtein Current Perfusion Bioreactor) with proportional-integral-derivative control of pH, dissolved O(2) (DO), agitation, and temperature. During 6 days of culture, the total cell number increased from 2.0?×?10(9) to 3.2?×?10(10) cells. The maximum virus titers of 768 hemagglutinin units/100 ?L and 7.8?×?10(7) 50 % tissue culture infectious doses/mL were obtained 3 days after infection. These results demonstrate that using a disposable perfusion bioreactor for large-scale cultivation of MDCK cells, which allows for the control of DO, pH, and other conditions, is a convenient and stable platform for industrial-scale production of influenza vaccines. PMID:22945265

Sun, Bo; Yu, Xianghui; Kong, Wei; Sun, Shiyang; Yang, Ping; Zhu, Changlin; Zhang, Haihong; Wu, Yongge; Chen, Yan; Shi, Yuhua; Zhang, Xizhen; Jiang, Chunlai

2012-09-04

422

Production and characterization of vaccines based on flaviviruses defective in replication  

SciTech Connect

To develop new vaccine candidates for flavivirus infections, we have engineered two flaviviruses, yellow fever virus (YFV) and West Nile virus (WNV), that are deficient in replication. These defective pseudoinfectious viruses (PIVs) lack a functional copy of the capsid (C) gene in their genomes and are incapable of causing spreading infection upon infection of cells both in vivo and in vitro. However, they produce extracellular E protein in form of secreted subviral particles (SVPs) that are known to be an effective immunogen. PIVs can be efficiently propagated in trans-complementing cell lines making high levels of C or all three viral structural proteins. PIVs derived from YFV and WNV, demonstrated very high safety and immunization produced high levels of neutralizing antibodies and protective immune response. Such defective flaviviruses can be produced in large scale under low biocontainment conditions and should be useful for diagnostic or vaccine applications.

Mason, Peter W. [Department of Microbiology and Immunology, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-1019 (United States); Department of Pathology, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-1019 (United States); Sealy Center for Vaccine Development, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-1019 (United States); Shustov, Alexandr V. [Department of Microbiology and Immunology, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-1019 (United States); Frolov, Ilya [Department of Microbiology and Immunology, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-1019 (United States)]. E-mail: ivfrolov@utmb.edu

2006-08-01

423

Increased biological hydrogen production with reduced organic loading  

Microsoft Academic Search

An experimental matrix consisting of reactor hydraulic retention time (HRT) and glucose loading rate was tested to understand the effect of organic loading on H2 production in chemostat reactors. In order to vary the glucose loading rate over a range of 0.5–18.9g\\/h, the glucose concentration in the feed was varied from 2.5 to 10gCOD\\/L under conditions where the HRT varied

Steven W. Van Ginkel; Bruce Logan

2005-01-01

424

Production and flocculating performance of sludge bioflocculant from biological sludge.  

PubMed

Excess biological sludge was utilized to prepared bioflocculant with hydrochloric acid. The prepared crude bioflocculant was purified and fractionally precipitated to attain four purified sludge bioflocculant defined as PSB1-4. The PSB-2 has higher flocculating rate for kaolin suspension than others. When the pH of the flocculation system ranged from 4.0 to 11.0 the flocculating rates of PSB-2 were over 96.0%. X-ray photoelectron spectroscopy (XPS) and Fourier transform infrared (FTIR) spectra showed that amino and hydroxyl groups were present in the bioflocculant molecules. More amine group existed in the bioflocculant PSB-2 relatively. The amino group was believed to play an important role in flocculation. The experiment of zeta potential measuring indicated that the charge neutralization contributed to flocculation process. Flocculating mechanism investigation reveals that the sludge bioflocculant caused kaolin suspension instability by means of charge neutralization firstly and then promoted the aggregation of suspension particles by adsorption and bridge. PMID:23916978

Zhang, Xiuhong; Sun, Jie; Liu, Xiuxiu; Zhou, Jiti

2013-07-13

425

Metabolic engineering for production of biorenewable fuels and chemicals: contributions of synthetic biology.  

PubMed

Production of fuels and chemicals through microbial fermentation of plant material is a desirable alternative to petrochemical-based production. Fermentative production of biorenewable fuels and chemicals requires the engineering of biocatalysts that can quickly and efficiently convert sugars to target products at a cost that is competitive with existing petrochemical-based processes. It is also important that biocatalysts be robust to extreme fermentation conditions, biomass-derived inhibitors, and their target products. Traditional metabolic engineering has made great advances in this area, but synthetic biology has contributed and will continue to contribute to this field, particularly with next-generation biofuels. This work reviews the use of metabolic engineering and synthetic biology in biocatalyst engineering for biorenewable fuels and chemicals production, such as ethanol, butanol, acetate, lactate, succinate, alanine, and xylitol. We also examine the existing challenges in this area and discuss strategies for improving biocatalyst tolerance to chemical inhibitors. PMID:20414363

Jarboe, Laura R; Zhang, Xueli; Wang, Xuan; Moore, Jonathan C; Shanmugam, K T; Ingram, Lonnie O

2010-04-06

426

An adapted F-test for homogeneity of variability in follow-on biological products.  

PubMed

In recent years, follow-on biological products (biosimilars) have received much attention from both the biotechnology industry and the regulatory agencies, especially after the passage of the 2010 healthcare reform bill. Unlike the traditional small-molecule drug products, the development of biological products is not only more complicated but also sensitive to small changes (both mean and variation) in procedure/environment during the manufacturing process because of some fundamental differences between drug products and biological products. A small change will have an impact on the quality of the product and consequently the treatment effect. Thus, in addition to the assessment of biosimilarity in average, it was suggested that biosimilarity in variability between biological products should be assessed. In this article, we propose an adapted F-test for homogeneity of variances to assess biosimilarity in variability. We study the performance and concordance of the proposed adapted F-test and compare it with probability-based method by extensive Monte Carlo simulations. PMID:22933180

Yang, Jun; Zhang, Nan; Chow, Shein-Chung; Chi, Eric

2012-08-30

427

[Travelers' vaccines].  

PubMed

The number of Japanese oversea travelers has gradually increased year by year, however they usually pay less attention to the poor physical condition at the voyage place. Many oversea travelers caught vaccine preventable diseases in developing countries. The Vaccine Guideline for Oversea Travelers 2010 published by Japanese Society of Travel Health will be helpful for spreading the knowledge of travelers' vaccine and vaccine preventable diseases in developing countries. Many travelers' vaccines have not licensed in Japan. I hope these travelers' vaccines, such as typhoid vaccine, meningococcal vaccine, cholera vaccine and so on will be licensed in the near future. PMID:21922760

Ouchi, Kazunobu

2011-09-01

428

Bacterial and other biological systems for polyester production.  

PubMed

Poly(3-hydroxybutyric acid) and other structurally related aliphatic polyesters from bacteria, referred to as polyhydroxyalkanoic acids, form biodegradable thermoplastics and elastomers that are currently in use, or being considered for use, in industry, medicine, pharmacy and agriculture. At present, they are produced by microbial fermentations; in the future, production will also be possible by in vitro methods or by agriculture using transgenic plants. Representatives from this highly diverse class of polyesters might be produced as commodity chemicals for bulk applications, and others as fine chemicals for special applications. PMID:9807839

Steinbüchel, A; Füchtenbusch, B

1998-10-01

429

Production, Secretion and Biological Activity of Bacillus cereus Enterotoxins  

PubMed Central

Bacillus cereus behaves as an opportunistic pathogen frequently causing gastrointestinal diseases, and it is increasingly recognized to be responsible for severe local or systemic infections. Pathogenicity of B. cereus mainly relies on the secretion of a wide array of toxins and enzymes and also on the ability to undergo swarming differentiation in response to surface-sensing. In this report, the pathogenicity exerted by B. cereus toxins is described with particular attention to the regulatory mechanisms of production and secretion of HBL, Nhe and CytK enterotoxins.

Senesi, Sonia; Ghelardi, Emilia

2010-01-01

430

Biological Degradation of Common Pharmaceuticals and Personal Care Products in Soils with High Water Content  

Microsoft Academic Search

Biological degradation rates of six pharmaceuticals and personal care products were examined in soil from a land application\\u000a site and in adjacent soil with no prior history of effluent exposure. Microbial degradation rates were compared over 2 weeks\\u000a under standing water or saturated conditions and draining conditions after having been saturated for 3 days. Biological degradation\\u000a of 17?-estradiol exhibited rapid rates of

Deborah L. Carr; Audra N. Morse; John C. Zak; Todd A. Anderson

2011-01-01

431

The Danish vaccination register.  

PubMed

Immunisation information systems (IIS) are valuable tools for monitoring vaccination coverage and for estimating vaccine effectiveness and safety. Since 2009, an advanced IIS has been developed in Denmark and will be implemented during 2012–14. This IIS is based on a database existing since 2000. The reporting of all administered vaccinations including vaccinations outside the national programme will become mandatory. Citizens will get access to data about their own vaccinations and healthcare personnel will get access to information on the vaccinations of their patients. A national concept of identification, a national solution combining a personal code and a card with codes, ensures easy and secure access to the register. From the outset, the IIS will include data on childhood vaccinations administered from 1996 and onwards. All Danish citizens have a unique identifier, a so called civil registration number, which allows the linking of information on vaccinations coming from different electronic data sources. The main challenge will be to integrate the IIS with the different electronic patient record systems currently existing at general practitioner, vaccination clinic and hospital level thereby avoiding double-entry. A need has been identified for an updated international classification of vaccine products on the market. Such a classification would also be useful for the future exchange of data on immunisations from IIS between countries. PMID:22551494

Grove Krause, T; Jakobsen, S; Haarh, M; Mølbak, K

2012-04-26

432

Vaccines against Francisella tularensis.  

PubMed

Francisella tularensis is one of the most pathogenic pathogens known, especially when disseminated as a small particle aerosol. Because of this, it was developed into a biological warfare agent by several states during the 20th century. Nowadays, concerns remain about the potential of this pathogen to cause widespread disease, tularemia, in the hands of terrorists. This has resurrected interest in methods to combat it. This article reviews the current status of vaccine development efforts against tularemia. To date most of our understanding of tularemia vaccine efficacy has been derived from the clinical and experimental use of a pragmatically attenuated live vaccine strain of F. tularensis subspecies holarctica. However, this vaccine which has been in existence for more than 50 years is still beset by regulatory issues that continue to hamper its licensure. These issues and possible solutions are highlighted, along with more modern molecular approaches to vaccine development against this highly virulent pathogen. PMID:17395730

Wayne Conlan, J; Oyston, Petra C F

2007-03-29

433

Recent progress in synthetic biology for microbial production of C3-C10 alcohols.  

PubMed

The growing need to address current energy and environmental problems has sparked an interest in developing improved biological methods to produce liquid fuels from renewable sources. While microbial ethanol production is well established, higher-chain alcohols possess chemical properties that are more similar to gasoline. Unfortunately, these alcohols (except 1-butanol) are not produced efficiently in natural microorganisms, and thus economical production in industrial volumes remains a challenge. Synthetic biology, however, offers additional tools to engineer synthetic pathways in user-friendly hosts to help increase titers and productivity of these advanced biofuels. This review concentrates on recent developments in synthetic biology to produce higher-chain alcohols as viable renewable replacements for traditional fuel. PMID:22701113

Lamsen, Edna N; Atsumi, Shota

2012-06-08

434

Recent progress in synthetic biology for microbial production of C3-C10 alcohols  

PubMed Central

The growing need to address current energy and environmental problems has sparked an interest in developing improved biological methods to produce liquid fuels from renewable sources. While microbial ethanol production is well established, higher-chain alcohols possess chemical properties that are more similar to gasoline. Unfortunately, these alcohols (except 1-butanol) are not produced efficiently in natural microorganisms, and thus economical production in industrial volumes remains a challenge. Synthetic biology, however, offers additional tools to engineer synthetic pathways in user-friendly hosts to help increase titers and productivity of these advanced biofuels. This review concentrates on recent developments in synthetic biology to produce higher-chain alcohols as viable renewable replacements for traditional fuel.

Lamsen, Edna N.; Atsumi, Shota

2012-01-01

435

Stability of Poly(?-caprolactone) Microparticles Containing Brucella ovis Antigens as a Vaccine Delivery System Against Brucellosis  

Microsoft Academic Search

In previous works, our research group has successfully proved the use of subcellular vaccines based on poly(?-caprolactone)\\u000a (PEC) microparticles containing an antigenic extract of Brucella ovis (HS) against experimental brucellosis in both mice and rams. However, the successful exploitation of pharmaceutical products,\\u000a and therefore of this product as veterinary vaccine, requires preservation of both biological activity and native structure\\u000a in

Maite Estevan; Carlos Gamazo; Fernando Martínez-Galan; Juan M. Irache

2008-01-01

436

Process development for the production of an E. coli produced clinical grade recombinant malaria vaccine for Plasmodium vivax  

Microsoft Academic Search

The global eradication of malaria will require the development of vaccines to prevent infection cause by Plasmodium vivax in addition to Plasmodium falciparum. In an attempt to contribute to this effort we have previously reported the cloning and expression of a vaccine based on the circumsporozoite protein of P. vivax. The synthetic vaccine encodes for a full-length molecule encompassing the

Brian A. Bell; James F. Wood; Reeta Bansal; Hatem Ragab; John Cargo III; Michael A. Washington; Chloe L. Wood; Lisa A. Ware; Christian F. Ockenhouse; Anjali Yadava

2009-01-01

437

Polio Vaccination  

MedlinePLUS

... Settings Overview Prevention & Control Resources on Proper Vaccine Storage and Handling Vaccine Recommendations ACIP recommendations Updated August 2009 Contraindications Consult package inserts for vaccine storage and handling guidance: ( IPOL , Kinrix , Pediarix , Pentacel , and ...

438

Leptospirosis vaccines  

PubMed Central

Leptospirosis is a serious infection disease caused by pathogenic strains of the Leptospira spirochetes, which affects not only humans but also animals. It has long been expected to find an effective vaccine to prevent leptospirosis through immunization of high risk humans or animals. Although some leptospirosis vaccines have been obtained, the vaccination is relatively unsuccessful in clinical application despite decades of research and millions of dollars spent. In this review, the recent advancements of recombinant outer membrane protein (OMP) vaccines, lipopolysaccharide (LPS) vaccines, inactivated vaccines, attenuated vaccines and DNA vaccines against leptospirosis are reviewed. A comparison of these vaccines may lead to development of new potential methods to combat leptospirosis and facilitate the leptospirosis vaccine research. Moreover, a vaccine ontology database was built for the scientists working on the leptospirosis vaccines as a starting tool.

Wang, Zhijun; Jin, Li; Wegrzyn, Alicja

2007-01-01

439

Vaccine Safety.  

National Technical Information Service (NTIS)

Immunizations are among the most cost-effective and widely used public health interventions. However, no vaccine is perfectly safe or effective. As the incidence of vaccine-preventable diseases is reduced by increasing coverage with vaccines public concer...

1998-01-01

440

Protection against anthrax toxin by vaccination with a DNA plasmid encoding anthrax protective antigen  

Microsoft Academic Search

A DNA vaccine encoding the immunogenic and biologically active portion of anthrax protective antigen (PA) was constructed. Spleen cells from BALB\\/c mice immunized intramuscularly with this vaccine were stimulated to secrete IFN? and IL-4 when exposed to PA in vitro. Immunized mice also mounted a humoral immune response dominated by IgG1 anti-PA antibody production, the subclass previously shown to confer

Mi-Li Gu; Stephen H Leppla; Dennis M Klinman

1999-01-01

441

Production of the 42-kDa fragment of Plasmodium falciparum merozoite surface protein 1, a leading malaria vaccine antigen, in Arabidopsis thaliana seeds.  

PubMed

Malaria is widely associated with poverty, and a low-cost vaccine against malaria is highly desirable for implementing comprehensive vaccination programmes in developing countries. Production of malaria antigens in plants is a promising approach, but its development has been hindered by poor expression of the antigens in plant cells. In the present study, we targeted plant seeds as a low-cost vaccine production platform and successfully expressed the Plasmodium falciparum 42-kDa fragment of merozoite surface protein 1 (MSP1??), a leading malaria vaccine candidate, at a high level in transgenic Arabidopsis seeds. We overcame hurdles of transcript and protein instabilities of MSP1?? in plants by synthesizing a plant-optimized MSP1?? cDNA and either targeting the recombinant protein to protein storage vacuoles or fusing it with a stable plant storage protein. An exceptional improvement in MSP1?? expression, from an undetectable level to 5% of total extractable protein, was achieved with these combined strategies. Importantly, the plant-derived MSP1?? maintains its natural antigenicity and can be recognized by immune sera from malaria-infected patients. Our results provide a strong basis for the development of a plant-based, low-cost malaria vaccine. PMID:20444208

Lau, On Sun; Ng, Danny W-K; Chan, Wendy W L; Chang, Sandra P; Sun, Samuel S M

2010-12-01

442

Patterns of cytokine production and proliferation by T lymphocytes differ in mice vaccinated or infected with Schistosoma mansoni.  

PubMed Central

C57BL/6 mice vaccinated with irradiated cercariae of Schistosoma mansoni are highly resistant to challenge infection. To examine the role of T-helper (Th) activity in these vaccinated (V20) mice, cells from skin- and lung-draining lymph nodes (LN) and the spleen were cultured in vitro with soluble schistosomular antigen. Peak proliferation and release of T-cell growth factor (TCGF) by axillary LN cells on Day 5, and by mediastinal LN cells on Day 18, reflected the kinetics of parasite migration. High levels of interferon-gamma (IFN-gamma) were detected and production was prolonged, particularly in the mediastinal LN. The majority of the above activity was ablated with anti-CD4 antibody. IFN-gamma production by spleen cells increased, whilst proliferation and TCGF release remained low. Although levels of proliferation were similar, more IFN-gamma was released by LN cells from V20 mice than by those from mice infected with normal parasites (NI). This difference in IFN-gamma production was magnified by the greater number of cells in LN of V20 than NI mice. On Day 22 post-exposure, 24-fold more IFN-gamma was produced per pair of axillary LN in the former group. LN cells from V20 mice produced interleukin (IL)-2 and IL-4, whereas those from NI mice released IL-2 but negligible IL-4. Greater quantities of IL-3 were secreted by cells from V20 than from NI mice. These results support the conclusion that IFN-gamma-producing memory Th cells, generated in the LN of V20 mice, play an important role in protective immunity against S. mansoni.

Pemberton, R M; Smythies, L E; Mountford, A P; Wilson, R A

1991-01-01

443

Immunologic Monitoring of Cancer Vaccine Therapy: Results of a Workshop Sponsored by the Society for Biological Therapy  

Microsoft Academic Search

Summary: The Society for Biological Therapy held a Workshop last fall devoted to immune monitoring for cancer immunotherapy trials. Participants included members of the academic and pharmaceutical communities as well as the National Cancer Institute and the Food and Drug Administration. Discussion focused on the relative merits and appropriate use of various immune monitoring tools. Six breakout groups dealt with

Ulrich Keilholz; Jeffrey Weber; James H. Finke; Dmitry I. Gabrilovich; W. Martin Kast; Mary L. Disis; John M. Kirkwood; Carmen Scheibenbogen; Jeff Schlom; Vernon C. Maino; H. Kim Lyerly; Peter P. Lee; Walter Storkus; Franceso Marincola; Alexandra Worobec; Michael B. Atkins

444

Plasmodium vivax Sporozoite Production in Anopheles albimanus Mosquitoes for Vaccine Clinical Trials  

PubMed Central

Vaccine development for Plasmodium vivax malaria is underway. A model to assess the protective efficacy of vaccine candidates in humans is urgently needed. Given the lack of continuous P. vivax cultures, we developed a system to infect Anopheles albimanus mosquitoes using blood from P. vivax-infected patients and determined parameters for challenge of malaria-naive volunteers by mosquito bite. Absence of co-infections in parasitized blood was confirmed by tests consistent with blood bank screening. A total of 119 experiments were conducted using batches of 900–4,500 mosquitoes fed by an artificial membrane feeding method. Optimal conditions for mosquito probing and infection were determined. Presence of oocyst and sporozoites were assessed on Days 7–8 and 14–15, respectively, and conditions to choose batches of infected mosquitoes for sporozoite challenge were established. Procedures to infect volunteers took a 2-hour period including verification of inoculum dose. Anopheles albimanus mosquitoes represent a valuable resource for P. vivax sporozoite challenge of volunteers.

Solarte, Yezid; Manzano, Maria R.; Rocha, Leonardo; Hurtado, Hugo; James, Mark A.; Arevalo-Herrera, Myriam; Herrera, Socrates

2011-01-01

445

[Risk of smallpox, vaccination, bioterrorism].  

PubMed

The use of the smallpox virus as a biological weapon is very old. Confronted with a high probability of a current bioterrorist menace, counteracting strategies have been developed. One of the principle aims relies on the vaccination of teams dedicated to the management of persons infected and the stocking of vaccine for the whole population of a country. Following worldwide eradication of the disease, preventive vaccination was topped in 1978 in France for the primo-vaccination, and in 1984 for repeat vaccinations. The various strains used in the first generation vaccinations are weakened living vaccine, the natural host and origin of which is unknown. Second and third generations vaccines are under study; the principle objective is to obtain efficacy with a minimum of side effects. There are two types of adverse events, generally observed with the first generation vaccines: the first, extremely rare, can be life-threatening; the others, more frequent (10 to 15% of patients) are benign. In emergency situations, in the presence of smallpox, there should be no absolute contraindications to vaccination. In the bioterrorist context, massive vaccination campaigns of the population are unadvisable (because of the considerable risk of death and severe adverse events) in the absence of any real permit, in each case, definition of the vaccinal strategy to be adopted. PMID:15706726

Bossi, P; Garin, D; Combadière, B; Rouleau, E; Rigaudeau, S; LebrunVignes, B; Martinez, V; Autran, B; Bricaire, F

2005-01-29

446

Cell surface display of highly pathogenic avian influenza hemagglutinin on the surface of Pichia pastoris cells using alpha-agglutinin for production of oral vaccines  

Technology Transfer Automated Retrieval System (TEKTRAN)

Yeast are an ideal organism to express viral antigens because yeast glycosylate proteins are more similar to mammals than bacteria, and expression of proteins in yeast is relatively fast and inexpensive. In addition to the convenience of production, for purposes of vaccination, yeast have been show...

447

The role of synthetic biology in the design of microbial cell factories for biofuel production.  

PubMed

Insecurity in the supply of fossil fuels, volatile fuel prices, and major concerns regarding climate change have sparked renewed interest in the production of fuels from renewable resources. Because of this, the use of biodiesel has grown dramatically during the last few years and is expected to increase even further in the future. Biodiesel production through the use of microbial systems has marked a turning point in the field of biofuels since it is emerging as an attractive alternative to conventional technology. Recent progress in synthetic biology has accelerated the ability to analyze, construct, and/or redesign microbial metabolic pathways with unprecedented precision, in order to permit biofuel production that is amenable to industrial applications. The review presented here focuses specifically on the role of synthetic biology in the design of microbial cell factories for efficient production of biodiesel. PMID:22028591

Colin, Verónica Leticia; Rodríguez, Analía; Cristóbal, Héctor Antonio

2011-10-15

448

Construction of Live Vaccines by Using Genetically Engineered Poxviruses: Biological Activity of Recombinant Vaccinia Virus Expressing Influenza Virus Hemagglutinin  

Microsoft Academic Search

Recombinant vaccinia viruses containing the cloned hemagglutinin (HA) gene from influenza virus were constructed. The biological activity of these poxvirus vectors was demonstrated both in vitro and in vivo. Expression of HA in cells infected with recombinant vaccinia was detected by using specific anti-HA antiserum and 125I-labeled protein A, showing that HA synthesized under the regulation of vaccinia virus was

Dennis Panicali; Stephen W. Davis; Randall L. Weinberg; Enzo Paoletti

1983-01-01

449

Current studies on biological tagatose production using l-arabinose isomerase: a review and future perspective  

Microsoft Academic Search

d-Tagatose is a hexoketose monosaccharide sweetener, which is an isomer of d-galactose and is rarely found in nature. Recently, there has been industrial interest in d-tagatose as a low-calorie sugar-substituting sweetener. This article describes the properties and metabolism of tagatose as well as its commercial importance. The comparison between the biological tagatose production and the chemical production was reviewed based

Pil Kim

2004-01-01

450

Recovery of ?-chain expression and changes in spontaneous IL-10 production after PSA-based vaccines in patients with prostate cancer  

PubMed Central

Circulating T lymphocytes of patients with prostate cancer have been reported to have functional deficits, including low or absent ?-chain expression. To determine whether these functional impairments could be reversed by prostate specific antigen-based vaccination therapy, 10 patients treated with recombinant human prostate specific antigen plus GM-CSF and eight others receiving prostate specific antigen plus oil emulsion in two pilot clinical trials were evaluated prior to and after vaccination for several immunologic end points, including ?-chain expression and cytokine production by circulating T cells as well as the frequency of T cells able to respond to prostate specific antigen in ELISPOT assays. The flow cytometry assay for ?-chain expression was standardized to allow for a reliable comparison of pre- vs post-vaccination samples. Prior to therapy, the patients were found to have significantly lower ?-chain expression in circulating CD3+ cells and a higher percentage of ?-chain negative CD3+ and CD4+ cells than normal donors. The patients' peripheral blood mononuclear cells spontaneously produced more IL-10 ex vivo than those of normal controls. After vaccination, recovery of ?-chain expression was observed in 50% of patients in both clinical trials. Also, spontaneous IL-10 secretion by peripheral blood mononuclear cells decreased following immunotherapy in patients treated with prostate specific antigen and GM-CSF. The frequency of prostate specific antigen-reactive T cells was detectable in 7 out of 18 patients vs 4 out of 18 patients prior to vaccination. Only one of 18 patients was a clinical responder. The vaccine had stimulatory effects on the patients' immune system, but post-vaccine immune recovery could not be correlated to progression-free survival in this small cohort of patients with prostate cancer. British Journal of Cancer (2002) 86, 168–178. DOI: 10.1038/sj/bjc/6600039 www.bjcancer.com © 2002 The Cancer Research Campaign

Meidenbauer, N; Gooding, W; Spitler, L; Harris, D; Whiteside, T L

2002-01-01

451

Exploiting plug-and-play synthetic biology for drug discovery and production in microorganisms  

Microsoft Academic Search

One of the most promising applications of synthetic biology is the biosynthesis of new drugs from secondary metabolites. Here, we survey a wide range of strategies that control the activity of biosynthetic modules in the cell in space and time, and illustrate how these strategies can be used to design efficient cellular synthetic production systems. Re-engineered versions of secondary metabolite

Marnix H. Medema; Rainer Breitling; Roel Bovenberg; Eriko Takano

2010-01-01

452

Recent advances in the production of proteins in insect and mammalian cells for structural biology  

Microsoft Academic Search

The production of proteins in sufficient quantity and of appropriate quality is an essential pre-requisite for structural studies. Escherichia coli remains the dominant expression system in structural biology with nearly 90% of the structures in the Protein Data Bank (PDB) derived from proteins produced in this bacterial host. However, many mammalian and eukaryotic viral proteins require post-translation modification for proper

Joanne E. Nettleship; René Assenberg; Jonathan M. Diprose; Nahid Rahman-Huq; Raymond J. Owens

2010-01-01

453

The Analysis of Cyanide and its Breakdown Products in Biological Samples  

Microsoft Academic Search

Cyanide is a toxic chemical that may be introduced into living organisms as a result of natural processes and\\/or anthropogenic uses (legal or illicit). Exposure to cyanide can be verified by analysis of cyanide or one of its breakdown products from biological samples. This verification may be important for medical, law-enforcement, military, forensic, research, or veterinary purposes. This review will

Brian A. Logue; Diane M. Hinkens; Steven I. Baskin; Gary A. Rockwood

2010-01-01

454

9 CFR 113.53 - Requirements for ingredients of animal origin used for production of biologics.  

Code of Federal Regulations, 2013 CFR

...sterilization of other sterilization methods acceptable to APHIS used to prepare a biological product shall be shown free of bacteria and fungi as prescribed in § 113.26. (c) Samples of each lot of ingredient of animal origin, except porcine trypsin,...

2013-01-01

455

9 CFR 113.51 - Requirements for primary cells used for production of biologics.  

Code of Federal Regulations, 2013 CFR

...harvested material or samples of each subculture of cells used to prepare the biological product shall be shown free of bacteria and fungi as prescribed in § 113.26 or § 113.27 (whichever is applicable). (c) A monolayer at least 75 cm2 from each...

2013-01-01

456

Glycan analysis in cell culture-based influenza vaccine production: influence of host cell line and virus strain on the glycosylation pattern of viral hemagglutinin.  

PubMed

Mammalian cell culture processes are commonly used for production of recombinant glycoproteins, antibodies and viral vaccines. Since several years there is an increasing interest in cell culture-based influenza vaccine production to overcome limitations of egg-based production systems, to improve vaccine supply and to increase flexibility in vaccine manufacturing. With the switch of the production system several key questions concerning the possible impact of host cell lines on antigen quality, passage-dependent selection of certain viral phenotypes or changes in hemagglutinin (HA) conformation have to be addressed to guarantee safety and efficiency of vaccines. In contrast to the production of recombinant glycoproteins, comparatively little is known regarding glycosylation of HA, derived from mammalian cell cultures. Within this study, a capillary DNA-sequencer (based on CGE-LIF technology), was utilized for N-glycan analysis of three different influenza virus strains, which were replicated in six different cell lines. Detailed results concerning the influence of the host cell line on complexity and composition of the HA N-glycosylation pattern, are presented. Strong host cell but also virus type and subtype dependence of HA N-glycosylation was found. Clear differences were already observed, by N-glycan fingerprint comparison. Further structural investigations of the N-glycan pools revealed that host cell dependence of HA N-glycosylation was mainly related to minor variations of the (monomeric) constitution of single N-glycans. To some extent, shifts in the N-glycan pool composition regarding the proportion of different N-glycan types were observed. In contrast to this, a principal switch of the N-glycan type attached to HA was observed when comparing different virus types (A and B) and subtypes (H1N1 and H3N2). PMID:19410619

Schwarzer, Jana; Rapp, Erdmann; Hennig, René; Genzel, Yvonne; Jordan, Ingo; Sandig, Volker; Reichl, Udo

2009-05-14

457

[Special considerations for the regulation of biological medicinal products in individualised medicine : More than stratified medicine].  

PubMed

The term individualised medicine, also called personalised medicine, is commonly used as an equivalent to stratified medicine. However, this is erroneous since quite often it is forgotten that especially biological medicinal products have other aspects of individualization that go beyond mere stratification. The principles of stratified medicine have been applied for biological medicinal products for many years. A historical example is diphtheria antitoxin made from horse serum, while current examples are transfusion of red blood cells and the administration of factor VIII in haemophilia A. The stratifying aspects of these medicinal products are given by the following considerations: diphtheria antitoxin is only administered after a diagnosis of diphtheria and not in other forms of tonsillitis, red blood cells should only be transfused once blood group compatibility as been established and factor VIII replacement is only administered in haemophilia A as opposed to other acquired or hereditary disease of the coagulation system. The peculiarities of biological medicinal products, in particular the inherent variability of the drug, are especially important for autologous cellular medicinal products. In addition to the expected variability of the biological source material there is interindividual variability of patients as cell donors, which make definition of specifications and determination of criteria for pharmaceutical quality and potency tests difficult. Therapy with modified autologous cells, a common and important application of advanced therapy medicinal products, is exemplary for the special considerations that must be made when evaluating pharmaceutical quality, mode of action and toxicological properties of the biological medicine. The clinical investigation of advanced therapy medicinal products with the intent of demonstrating safety and efficacy is particularly challenging because of the complexity of therapy, which often involves invasive interventions. The development of biomarkers accelerates the process towards stratified or individualised therapies. Increased requirements for companion diagnostics are a possible consequence. Progress in analytical processes and in biotechnology make a higher degree of individualization likely, possibly to the degree that medicinal products will be individually manufactured for each patient. Current principles of medicinal product testing and market authorization may be applicable only with limitations, because the individual medicinal products are not uniform and are not repeatedly manufactured. The assessment of the process, performed on several different medicinal products manufactured by the same process could potentially serve as a basis for the assessment. For the evaluation of risk for the patient in clinical trials new concepts must be considered, which can be facilitated by interaction of regulatory authorities and developers. PMID:24170083

Müller-Berghaus, J; Volkers, P; Scherer, J; Cichutek, K

2013-11-01

458

Complete List of Vaccines Licensed for Immunization and ...  

Center for Biologics Evaluation and Research (CBER)

... Complete List of Vaccines Licensed for Immunization and Distribution in the US. Product Name, Trade Name, Sponsor. Adenovirus ... More results from www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts

459

Influenza Virus Vaccine Actions  

Center for Biologics Evaluation and Research (CBER)

... Approval of new bulk manufacturing facility for production of Influenza Virus Vaccine. -. Key Resources. ... Key Links. Flu.gov. -. Contact FDA. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety

460

Pricing of new vaccines  

PubMed Central

New vaccine pricing is a complicated process that could have substantial long-standing scientific, medical and public health ramifications. Pricing can have a considerable impact on new vaccine adoption and, thereby, either culminate or thwart years of research and development and public health efforts. Typically, pricing strategy consists of the following eleven components: (1) Conduct a target population analysis; (2) Map potential competitors and alternatives; (3) Construct a vaccine target product profile (TPP) and compare it to projected or actual TPPs of competing vaccines; (4) Quantify the incremental value of the new vaccine's characteristics; (5) Determine vaccine positioning in the marketplace; (6) Estimate the vaccine price-demand curve; (7) Calculate vaccine costs (including those of manufacturing, distribution, and research and development); (8) Account for various legal, regulatory, third party payer and competitor factors; (9) Consider the overall product portfolio; (10) Set pricing objectives; (11) Select pricing and pricing structure. While the biomedical literature contains some studies that have addressed these components, there is still considerable room for more extensive evaluation of this important area.

McGlone, Sarah M

2010-01-01

461

Plant derived veterinary vaccines  

Microsoft Academic Search

Infectious diseases remain one of the main causes of death and economic losses in animals despite the fact that prophylactic\\u000a vaccination has been extremely successful in disease prevention. New effective viral, bacterial and parasitic vaccines are\\u000a needed, but unfortunately production costs still remain prohibitive. In this respect plants can offer a valid alternative.\\u000a Production of antigenic proteins in plants relies

L. Santi

2009-01-01

462

Fiber fractions from processing of barley in production and conservation of a biologic control agent.  

PubMed

Carriers are frequently used to overcome problems associated with microbial survival in soil after inoculation. Moreover, the use of carriers can prolong the shelf lives and lessen dusting of both biofungicides and biologic fertilizers. This study investigated the suitability of barley-based fiber fractions as growth media and immobilization matrices in the cultivation of a Streptomyces griseoviridis biologic control agent, as well as for the conservation of obtained biomass in dehydrated hydrogel capsules. The second main ingredient in all the examined carrier matrices was alginate. The aim was to find a hydrogel formulation suited for a production process in which all individual steps, including cultivation of the organism; downstream processing; and formulation, storage, and application of the product (i.e., biologic control agent), are carried out in the hydrogel matrix. Of the tested fractions, brewer's spent grain was the best choice, when considering the price vs the nutrient contents as well as the storage time and ease of processing of the crude and the finished products. It seems that cereal fibers can be replenished with cereal fractions less rich in fiber but having a higher content of utilizable nutrients and, hence, better suited for the production of biomass. A high content of water-insoluble fiber favorably influenced the appearance as well as the applicability of the products. PMID:11456292

Tuomi, T; Heino, M; Nordström, K; Laakso, S

2001-05-01

463

Guidance for Industry. Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA).  

National Technical Information Service (NTIS)

This guidance is intended to assist developers of drugs, biological products, and medical devices intended for the treatment of rheumatoid arthritis (RA). The document discusses the types of label claims that can be considered for such products and provid...

1999-01-01

464

Guideline on Validation of the Limulus Amebocyte Lysate Test as End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices.  

National Technical Information Service (NTIS)

The guideline sets forth acceptable conditions for use of the Limulus Amebocyte Lysate test. It also describes procedures for using this methodology as an end-product endotoxin test for human injectable drugs (including biological products), animal inject...

1987-01-01

465

What controls biological productivity in coastal upwelling systems? Insights from a comparative modeling study  

NASA Astrophysics Data System (ADS)

The magnitude of the biological productivity in Eastern Boundary Upwelling Systems (EBUS) is traditionally viewed as directly reflecting the upwelling intensity. Yet, different EBUS show different sensitivities of productivity to upwelling-favorable winds (Carr and Kearns, 2003). Here, using a comparative modeling study of the California Current System (California CS) and Canary Current System (Canary CS), we show how physical and environmental factors, such as light, temperature and cross-shore circulation modulate the response of biological productivity to upwelling strength. To this end, we made a series of eddy-resolving simulations of the California CS and Canary CS using the Regional Ocean Modeling System (ROMS), coupled to a nitrogen based Nutrient-Phytoplankton-Zooplankton-Detritus (NPZD) ecosystem model. We find the nutrient content of the euphotic zone to be 20 % smaller in the Canary CS relative to the California CS. Yet, the biological productivity is 50 % smaller in the latter. This is due to: (1) a faster nutrient-replete growth in the Canary CS relative to the California CS, related to a more favorable light and temperature conditions in the Canary CS, and (2) the longer nearshore water residence times in the Canary CS which lead to larger buildup of biomass in the upwelling zone, thereby enhancing the productivity. The longer residence times in the Canary CS appear to be associated with the wider continental shelves and the lower eddy activity characterizing this upwelling system. This results in a weaker offshore export of nutrients and organic matter, thereby increasing local nutrient recycling and enhancing the coupling between new and export production in the Northwest African system. Our results suggest that climate change induced perturbations such as upwelling favorable wind intensification might lead to contrasting biological responses in the California CS and the Canary CS, with major implications for the biogeochemical cycles and fisheries in these two ecosystems.

Lachkar, Z.; Gruber, N.

2011-06-01

466

Anti-Sepsis Conjugate Vaccine.  

National Technical Information Service (NTIS)

The present invention provides an immunogenic conjugate comprising biologically deacylated gram-negative bacterial moieties linked to D. discoideum proteinase 1, as well as novel subunits thereof, and methods of making and using the conjugates in vaccines...

D. C. DeBorde G. L. Gustafson

2005-01-01

467

9 CFR 113.326 - Avian Pox Vaccine.  

Code of Federal Regulations, 2013 CFR

...INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS...VECTORS STANDARD REQUIREMENTS Live Virus Vaccines § 113.326 Avian Pox Vaccine...Pigeon Pox Vaccine shall be prepared from virus-bearing cell culture fluids or...

2013-01-01

468

Manufacture of Vaccines in Developing Countries: Background Paper.  

National Technical Information Service (NTIS)

This paper on the manufacture of vaccines in developing countries, with special reference to technology transfer covers (1) prevailing disease patterns in the world; world production of vaccines; transfer of technology for manufacture of classical vaccine...