Vaccine manufacturing

Vaccines

Volumn , Issue , 2008, Pages 45-58

  Gomez, Phillip L ^a   Robinson, James M ^b   Rogalewicz, Joseph ^c  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b NOVAVAX INC   (United States)

^c GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77955647702     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-1-4160-3611-1.50008-8     Document Type: Chapter

References (45)

1. DT Casto and PA Brunell (1991) Safe handling of vaccines. Pediatrics 87 108-112.
2. M Mathieu (Eds) (1997) Biologics development: a regulatory overview 2nd ed Waltham, MA: Parexel lnternational Corporation 123-124.
3. G Peter (1992) Childhood immunizations. N Engl J Med 327 1794-1800.
4. VS Mitchell, NM Philipose and JP Sanford (Eds) (1993) Achieving the vision Washington, DC: Institute of Medicine, National Academy Press The children's vaccine initiative
5. Centers for Disease Control and Prevention, National Vaccine Program Office Vaccine Fact Sheets, 2001:1. Online. Available at: www.cdc.gov/odInvpo/fs_tableII_doc2.htm
6. Code of Federal Regulations, Title 21, Sec. 601.2(a). Washington, DC: Office of the Federal Register, National Archives & Records Administration; April 1, 2001. http://www.fda.gov
7. PO Parkman and MC Hardegree (1999) Regulation and testing of vaccines. SA Plotkin, EA Mortimer, Jr (Eds) Vaccines, 3rd edn Philadelphia: WB Saunders 1131-1143.
8. M Mathieu Center for Biologics Evaluation and Research. Vaccines, February 20, 2002. Online. Available at: www.fda.gov/cber/vaccines.htm
9. Code of Federal Regulations, Title 21, Sec. 615 Washington, DC: Office of the Federal Register, National Archives & Records Administration
10. Code of Federal Regulations, Title 21, Sec. 211.166 Washington, DC: Office of the Federal Register, National Archives & Records Administration
11. Draft Guidelines for Industry Stability testing drug substances and drug products. Rockville, MD, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, June 1998. http://www.ich.org US Govt Printing Office, 1990.
12. Code of Federal Regulations, Title 21, Sec. 211.142 Washington, DC: Office of the Federal Register, National Archives & Records Administration
13. Product Information Fluzone®: Influenza Virus Vaccine Trivalent Types A and B (Zonal Purified, Subvirion) 2001–2002 Formula for 6 Months and Older. Swiftwater, PA: Aventis Pasteur, Inc.; April 2001. http://www.fda.gov
14. ED Kilboume, BE Johansson and B Grajower (1990) Independent and disparate evolution in nature of influenza A virus hemagglutinin and neuraminidase glycoproteins. Proc Natl Acad Sci USA 87 786-790.
15. Code of Federal Regulations, Title 21, Sec. 610.18 Washington, DC: Office of the Federal Register, National Archives & Records Administration
16. Hepatitis B vaccine evidence confirming lack of AIDS transmission. MMWR 33(49), 685-687.
17. FJ Mahoney and M Kane (1999) Hepatitis B vaccine. SA Plotkins, WA Orenstein (Eds) Vaccines, 3rd edn Philadelphia: WB Saunders 158-182.
18. Product Information (May 2001) Recombivax HB®: Hepatitis B Vaccine (Recombinant) West Point, PA: Merck & Co, Inc 1–14
19. Prescribing Information (December 2000) Engerix-B® Hepatitis B Vaccine (Recombinant) Philadelphia: GlaxoSmithKline
20. Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications FDA Cyberfax Info System: TX/RX No. 6045. May 7, 1997.
21. C Chu, R Schneerson, JB Robbins and SC Rastogi (1981) Further studies on the immunogenicity of Haemophilus influenzae type b and pneumococcal type 6A polysaccharide–protein conjugates. Infect and Immun 40(1), 245-256.
22. M Mathieu (1990) Clinical testing of new drugs. New Drug Development: A Regulatory Overview Cambridge, MA: Parexel International Corporation 83-104.
23. Code of Federal Regulations, Title 21, Secs. 211–226 Washington, DC: Office of the Federal Register, National Archives & Records Administration
24. Code of Federal Regulations, Title 21, Sec. 600 Washington, DC: Office of the Federal Register, National Archives & Records Administration
25. ICH Steering Committee, 2nd Steering Committee Meeting, Tokyo, Japan, 23–24 October 1990.
26. Rules and Guidance for Pharmaceutical Manufacturers and Distributors, Annex 15, Manufacture of Investigational Medicinal Products London: The Stationary Office
27. Norwood L. FDA Perspective on Approaches for Complying with cGMPs During Phase I INDs: Proposed Draft Guidance for Industry. FDA/PDA Joint Regulatory Conference September 19, 2005: Center for Biologics Evaluation and Research; 2005.
28. United States Pharmacopeia 27, <1047>, United States Pharmacopeial Convention, Inc. Rockville, MD, January 2004.
29. Federal Register Notice (1996) Office of the Federal Register. National Archives & Records Administration 61 2733-2739.
30. C Henry (1996) FDA, reform, and the well-characterized, analytical chemistry. American Chemical Society 68 674A-677A.
31. Hennessey J, Jr New analytical methods for old vaccines: when is it worth it? USP Conference on Biologics & Biotechnology Drug Substrances & Drug Products, November 18. Crystal City, VA: 2003.
32. United States Pharmacopeia 27, <1045>, United States Pharmacopeial Convention, Inc. Rockville, MD, January 2004.
33. Vaccine 20, (2002), 2411–2430, Reduction of animal use in human vaccine quality control; Opportunities and problems. Gideon F.A.
34. FA Gideon (2002) Reduction of animal use in human vaccine quality control; opportunities and problems. Vaccine 20 2411-2430.
35. United States Pharmacopeia 27, <1045> Rockville, MD: United States Pharmacopeial Convention
36. FA Gideon (2002) Reduction of animal use in human vaccine quality control; opportunities and programs. Vaccine 20 2411-2430.
37. OL Kistner, PN Barrett, W Mundt, et al. (1999) Development of a Vero cell-derived influenza whole virus Vaccine. Dev Biol Stand 98 101-110. discussion 111
38. MS Levy, RD O'Kennedy, MY Lo-Yim, et al. (2000) Biochemical engineering approaches to the challenges of producing pure plasmid DNA. Trends Biotechnol 18(7), 296-305.
39. M Hoare, MS Levy, DG Bracewell, et al. (2005) Bioprocess engineering issues that would be faced in producing a DNA vaccine at up to 100 m 3 fermentation scale for an influenza pandemic. Biotechnol Prog 21(6), 1577-1592.
40. DH Barouch (2006) Rational design of gene-based vaccines. J Pathol; 208(2), 283-289.
41. AR Goerke, BC To, AL Lee, et al. (2005) Development of a novel adenovirus purification process utilizing selective precipitation of cellular DNA. Biotechnol Bioeng 91(1), 12-21.
42. DF Clyde, et al. (1973) Immunization of Man Against Sporozite-induced Falciparum Malaria. Am J Med. Sc 266(3), 169-177.
43. TC Luke and SL Hoffman (2003) Rationale and plans for developing a non-replicating, metabolically active, radiation-attenuated plasmodium falciparum sporozoite vaccine. J Exp Biol 206(Pt 21), 3803-3808.
44. Position Statement on the Use of Tumourigenic Cells of Human origin for the Production of Biological and Biotechnological Medicinal Products, European Agency for the Evaluation of Medicinal Products, March 2001. www.emea.europe.eu
45. Vaccines and Related Biological Products Advisory Committee, May 16–17, 2001. www.fda.gov