4 - Vaccine manufacturing
References
- 1Safe handling of vaccinesPediatrics, 87 (1991), pp. 108-112
- 2Mathieu M. (Ed.), Biologics Development: A Regulatory Overview (2nd ed), Parexel International, Waltham, MA (1997), pp. 123-124
- 3Childhood immunizationsN Engl J Med, 327 (1992), pp. 1794-1800
- 4Mitchell V.S., Philipose N.M., Sanford J.P. (Eds.), The children's vaccine initiative: achieving the vision, Institute of Medicine, National Academy Press, Washington, DC (1993)
- 5Vaccine Fact Sheets[accessed 07.03.12]
- 6Code of Federal Regulations, Title 21, Sec. 601.2(a)Office of the Federal Register, National Archives & Records Administration, Washington, DC (2001)April 1[accessed 07.03.12]
- 7Regulation and testing of vaccinesPlotkin S.A., E.A. Mortimer Jr (Eds.), Vaccines (3rd ed), WB Saunders, Philadelphia, PA (1999), pp. 1131-1143
- 8Gruber F. Non-clinical Safety Evaluation of Preventative Vaccines: Regulatory Considerations. http://www.touchbriefings.com/pdf/16/Sutkowski.pdf. March 7, 2012.
- 9Code of Federal Regulations, Title 21, Sec. 615Office of the Federal Register, National Archives & Records Administration, Washington, DC (2001)April 1
- 10Code of Federal Regulations, Title 21, Sec. 211.166Office of the Federal Register, National Archives & Records Administration, Washington, DC (2001)April 1,
- 11Stability testing drug substances and drug productsCenter for Drug Evaluation and Research and Center for Biologics Evaluation and Research, Rockville, MD (1998)June[accessed 07.03.12]
- 12Code of Federal Regulations, Title 21, Sec. 211.142Office of the Federal Register, National Archives & Records Administration, Washington, DC (2001)April 1,
- 13Fluzone: Influenza Virus Vaccine Trivalent Types A and B (Zonal Purified, Subvirion) 2001–2002 Formula for 6 Months and Older [package insert]. Swiftwater, PA: Aventis Pasteur.
- 13aFDA approves first quadravalent influenza vaccine, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294057.htm [accessed 5/2/2012]
- 14Independent and disparate evolution in nature of influenza A virus hemagglutinin and neuraminidase glycoproteinsProc Natl Acad Sci U S A, 87 (1990), pp. 786-790
- 15Code of Federal Regulations, Title 21, Sec. 610.18Office of the Federal Register, National Archives & Records Administration, Washington, DC (2001)April 1,
- 16vaccine: evidence confirming lack of AIDS transmissionMMWR Morb Mortal Wkly Rep, 33 (1984), pp. 685-687
- 17A controlled clinical trial of the efficacy of the hepatitis B vaccine (Heptavax B): a final reportHepatology, 1 (1981), pp. 377-385
- 18Hepatitis B vaccinePlotkin S.A., Orenstein W.A. (Eds.), Vaccines (3 rd ed), WB Saunders, Philadelphia (1999), pp. 158-182
- 19Hepatitis B Vaccine (Recombinant)[package insert]Merck & Co, West Point, PA (2001)1–14, May
- 20Engerix-B\ Hepatitis B Vaccine (Recombinant)[package insert]GlaxoSmithKline, Philadelphia, PA (2000)December
- 21Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease IndicationsFDA Cyberfax Info System (1997)TX/RX No. 6045; May 7
- 22Further studies on the immunogenicity of Haemophilus influenzae type b and pneumococcal type 6A polysaccharide–protein conjugatesInfect Immun, 40 (1981), pp. 245-256
- 23Virus-like particles as a vaccine delivery system: myths and factsGuzman C., Feuerstein G. (Eds.), Pharmaceutical Biotechnology, Landes Bioscience/Springer Science, Austin, TX (2008)
- 24Virus-like particles in vaccine developmentExpert Rev Vaccines, 9 (2010), pp. 1149-1176
- 25Challenges for the production of virus-like particles in insect cells: the case of rotavirus-like particlesBiochem Eng J, 45 (2009), pp. 158-167
- 26GARDASIL: prophylactic human papillomavirus vaccine development: from bench top to bed-sideClin Pharmacol Ther, 81 (2007), pp. 259-264
- 27Clinical testing of new drugsNew Drug Development: A Regulatory Overview, Parexel International, Cambridge, MA (1990), pp. 83-104
- 28Code of Federal Regulations, Title 21, Sections 211–226Office of the Federal Register, National Archives & Records Administration, Washington, DC (2001)April 1,
- 29Code of Federal Regulations, Title 21, Sec. 600Office of the Federal Register, National Archives & Records Administration, Washington, DC (2001)April 1
- 302nd Steering Committee Meeting. Tokyo, Japan; 23–24 October (1990)
- 31Rules and Guidance for Pharmaceutical Manufacturers and Distributors, Annex 15, Manufacture of Investigational Medicinal ProductsThe Stationery Office, London, England (1996)December 2
- 32Perspective on Approaches for Complying with cGMPs During Phase I INDs: Proposed Draft Guidance for IndustryFDA/PDA Joint Regulatory Conference, Center for Biologics Evaluation and Research (2005)September 19,
- 33United States Pharmacopeia 27, section 1047United States Pharmacopeial Convention, Rockville, MD (2004)January
- 34Well-characterized biotechnology products: elimination of establishment license applicationFed Regist, 61 (1996), pp. 2733-2739
- 35FDA, reform, and the well-characterized biologicAnal Chem, 68 (1996), pp. 674A-677A
- 36New analytical methods for old vaccines: when is it worth it?USP Conference on Biologics & Biotechnology Drug Substances & Drug Products (2003)Crystal City, VA; November 18
- 37United States Pharmacopeia 27, section 1045United States Pharmacopeial Convention, Rockville, MD (2004)January
- 38Reduction of animal use in human vaccine quality control: opportunities and problemsVaccine, 20 (2002), pp. 2411-2430
- 39Development of a Vero cell–derived influenza whole virus vaccineDev Biol Stand, 98 (1999), pp. 101-111
- 40Biochemical engineering approaches to the challenges of producing pure plasmid DNATrends Biotechnol, 18 (2000), pp. 296-305
- 41Bioprocess engineering issues that would be faced in producing a DNA vaccine at up to 100 m3 fermentation scale for an influenza pandemicBiotechnol Prog, 21 (2005), pp. 1577-1592
- 42Rational design of gene-based vaccinesJ Pathol, 208 (2006), pp. 283-289
- 43Development of a novel adenovirus purification process utilizing selective precipitation of cellular DNABiotechnol Bioeng, 91 (2005), pp. 12-21
- 44Immunization of man against sporozite-induced falciparum malariaAm J Med Sci, 266 (1973), pp. 169-177
- 45Rationale and plans for developing a non-replicating, metabolically active, radiation-attenuated plasmodium falciparum sporozoite vaccineJ Exp Biol, 206 (pt 21) (2003), pp. 3803-3808
- 46Live attenuated malaria vaccine designed to protect through hepatic CD8+ T cell immunity[published online ahead of print September 8, 2011]Science, 334 (2011), pp. 475-480doi:10.1126/science.1211548
- 46aSeasonal influenza vaccine supply for 2011-2012 season, http://www.cdc.gov/flu/about/qa/vaxsupply.htm [accessed 5/2/2012]
- 47World Health Organization. Immunization supply and procurement. http://www.who.int/immunization_supply/guidelines/en/index.html[accessed 07.03.12].
- 48Sanofi to Acquire Shanta BiotechnicsFinancial Express (2009)July 28,[accessed 07.03.12]
- 49WHO withdraws pre-qualification of Sanofi-Aventis vaccineVaccineNewsDaily.com (2010)August 4,[accessed 07.03.12]
- 50FDA approves first therapeutic cancer vaccineNCI Cancer Bulletin (2010)May 4,[accessed 07.03.12]
- 51Therapeutic vaccines: realities of today and hopes for tomorrowProc Natl Acad Sci U S A, 101 (Suppl. 2) (2004), p. 14559[accessed 07.03.12]
- 52FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological ProductsFed Regist, 60 (1995), p. 35750
- 53Installation of a Bioreactor Suite Single-use Bioreactor Suite2nd Facilities Planning and Design for Pharmaceuticals (2007)Philadelphia, PA; Dec.
- 54Update: 1,000L Disposable Bioreactor System Evaluation and PerformanceIBC's 4th International Biopharmaceutical Manufacturing and Development Summit (2008)Durham, NC; Dec. 8–9,
- 55Disposable process equipment: developing a disposable processVaccines Europe (2008)December 4
Cited by (0)
Copyright © 2013 Elsevier Inc. All rights reserved.