253
Views
23
CrossRef citations to date
0
Altmetric
Review

Ensuring the quality, potency and safety of vaccines during preclinical development

, , &
Pages 855-866 | Published online: 09 Jan 2014

References

  • Tacket CO, Kotloff KL, Rennels MB. Initial clinical evaluation of new vaccine candidates: investigators’ perspective of Phase I and Phase II clinical trials of safety, immunogenicity, and preliminary efficacy. In: New Generation Vaccines. Levine MM (Ed.). Marcel Dekker Inc., NY, USA (2004).
  • EMEA. Note for guidance on the pharmacological and toxicological testing of vaccines. CPMP/SWP/465/95 17 December (1997).
  • FDA. Current Good Manufacturing Practice in Manufacuring, Processing, Packing or Holding of Drugs; General and Current Good Manufacturing Practice for Finished Pharmaceuticals. Code of Federal Regulations, Title 21, Parts 210 and 211 (21 CFR 210 and 21CFR211) (2001).
  • FDA. General Biological Products Standards. Code of federal regulations, Title 21, Part 610 (21 CFR 610) (2001).
  • Bacterial Endotoxin Test. United States Pharmacopeia (USP), Edition 28, Chapter 85.
  • CBER, FDA. Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product. January (1999).
  • ICH.Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/biological Products. 10 March, Tokyo, Japan (1999).
  • ICH.Q5E Comparability of Biotechnological/biological Products Subject to Changes in Their Manufacturing Process. 18 November, Yokohama, Japan (2004).
  • ICH. Q5C Quality of Biotechnology Products: Stability Testing of Biotechnological/biological Products. 30 November, Yokohama, Japan (1995).
  • ICH. Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. 5 March, Narita, Japan (1997).
  • NF 19 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. United States Pharmacopeia (USP), Edition XXIV (24) (2000).
  • CBER, FDA. Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals. Draft. January (1993).
  • ICH.Q5D quality of biotechnology/ biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products. 16 July, Brussels, Belgium (1997).
  • WHO. Requirements for the Use of Animal Cells as in Vitro Substrates for the Production of Biologicals. WHO Technical Report Series, No. 878. (1998).
  • CBER, FDA. Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy. March, Rockville MD, USA (1998).
  • FDA. Investigational New Drug Application. Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) (2005).
  • Fuchs F. Quality control of biotechnology-derived vaccines: technical and regulatory considerations. Biochimie 84(11), 1173–1179 (2002).
  • Lemercinier X, Jones C. An NMR spectroscopic identity test for the control of the capsular polysaccharide from Haemophilus influenzae type b. Biologicals 28(3), 175–183 (2000).
  • Bedwell J, Kairo SK, Behr MA, Bygraves JA. Identification of substrains of BCG vaccine using multiplex PCR. Vaccine 19(15–16), 2146–2151 (2001).
  • CBER, FDA. Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications. Draft. 17 February (2005).
  • FDA, CBER. Biologics Response Modifiers Advisory Committee Meeting. Nov 16–17, (2000).
  • Ma L, Bluyssen HA, De Raeymaeker M et al. Rapid determination of adenoviral vector titers by quantitative real-time PCR. J. Virol. Methods 93(1–2), 181–188 (2001).
  • Rohr UP, Wulf MA, Stahn S, Steidl U, Haas R, Kronenwett R. Fast and reliable titration of recombinant adeno-associated virus type-2 using quantitative real-time PCR. J. Virol. Methods 106(1), 81–88 (2002).
  • Katkocin DM. Characterization of multivalent pneumococcal conjugate vaccines. Dev. Biol. 103, 113–119 (2000).
  • Jumel K, Ho MM, Bolgiano B. Evaluation of meningococcal C oligosaccharide conjugate vaccines by size-exclusion chromatography/multi-angle laser light scattering. Biotechnol. Appl. Biochem. 36(Pt 3), 219–226 (2002).
  • Ashwell G. Colorimetric analysis of sugar. Methods Enzymology 3, 73–105 (1957).
  • Shabram PW, Giroux DD, Goudreau AM et al. Analytical anion-exchange HPLC of recombinant type-5 adenoviral particles. Hum. Gene Ther. 8(4), 453–465 (1997).
  • Greiner M, Carter P, Korn B, Zink D. New approach to complete automation in sizing and quantitation of DNA and proteins by the Automated Lab-on-a-Chip Platform from Agilent Technologies. Nature Methods 1, 87–89 (2004).
  • Bauer SR, Pilaro AM, Weiss KD. Testing of adenoviral vector gene transfer products: FDA expectations. In: Adenoviral Vectors for Gene Therapy. Curiel DT (Ed.). Academic Press, WA, USA (2002).
  • WHO Guidelines on Nonclinical Evaluation of Vaccines. WHO/BS/03.1969. 21 November (2003).
  • McVey DS, Galvin JE, Olson SC. A review of the effectiveness of vaccine potency control testing. Int. J. Parasitol. 33(5–6), 507–516 (2003).
  • Schofield T. In vitro versus in vivo concordance: a case study of the replacement of an animal potency test with an immunochemical assay. Dev. Biol. 111, 299–304 (2002).
  • Wang F, Puddy AC, Mathis BC et al. Using QPCR to assign infectious potencies to adenovirus based vaccines and vectors for gene therapy: toward a universal method for the facile quantitation of virus and vector potency. Vaccine 23(36), 4500–4508 (2005).
  • Roitsch C, Achstetter T, Benchaibi M et al. Characterization and quality control of recombinant adenovirus vectors for gene therapy. J. Chromatogr. B Biomed. Sci. Appl. 752(2), 263–280 (2001).
  • Thiede B, Hohenwarter W, Krah A et al. Peptide mass fingerprinting. Methods 35(3), 237–247 (2005).
  • Cohen SL, Chait BT. Mass spectrometry of whole proteins eluted from sodium dodecyl sulfate-polyacrylamide gel electrophoresis gels. Anal. Biochem. 247(2), 257–267 (1997).
  • Miles AP, Zhang Y, Saul A, Stowers AW. Large-scale purification and characterization of malaria vaccine candidate antigen Pvs25H for use in clinical trials. Protein Expr. Purif. 25(1), 87–96 (2002).
  • Jones DH, McBride BW, Roff MA, Farrar GH. Efficient purification and rigorous characterisation of a recombinant gp120 for HIV vaccine studies. Vaccine 13(11), 991–999 (1995).
  • Miles AP, Zhu Y, Saul A. Determining residual host cell antigen levels in purified recombinant proteins by slot blot and scanning laser densitometry. Methods Mol. Biol. 308, 233–242 (2005).
  • Lebron JA, Troilo PJ, Pacchione SJ et al. Adaptation of the WHO guideline for residual DNA in parenteral vaccines produced on continuous cell lines to a limit for oral vaccines. Dev. Biol. (2005) (In Press).
  • Gijsbers L, Koel B, Weggeman M, Goudsmit J, Havenga M, Marzio G. Quantification of residual host cell DNA in adenoviral vectors produced on PER.C6 cells. Hum. Gene Ther. 16(3), 393–398 (2005).
  • Ji X, Lee K, DiPaolo B. High-sensitivity hybridization assay for quantitation of residual E. coli DNA. Biotechniques 32(5), 1162–1167 (2002).
  • European Pharmacopeia, 2.6.8. Pyrogens. In: European Directorate for the Quality of Medicines, Fifth Edition, Vol. 1. 15 June (2004).
  • Nichols WW, Lardenoije R, Ledwith BJ et al. Propagation of adenoviral vectors: use of PER.C6 cells. In: Adenoviral Vectors for Gene Therapy. Curiel DT (Ed.) Academic Press, WA, USA, 129–166 (2002).
  • Ledwith BJ, Lanning CL, Gumprecht LA et al. Tumorigenicity assessments of PER.C6 cells and of an Ad5-vectored HIV-1 vaccine produced on this continuous cell line. Dev. Biol. (2005) (In Press).
  • CPMP, EMEA. Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products. CPMP/BWP/1793/02 18 June (2003).
  • CPMP, EMEA. Note for Guidance on Minimizing the Risk of Transmitting Animal TSE Agents via Human and Veterinary Medicinal Products. EMEA/410/01/rev 03.draft 23 June (2004).
  • CPMP, EMEA. Position Paper on ReEstablishment of Working Seeds and Working Cell Banks Using TSE Compliant Materials. EMEA/22314/02 10 September (2002).
  • CBER, FDA. Estimating Risks for vCJD in Vaccines Using Bovine-Derived Materials. (2001).
  • CPMP, EMEA. Public Statement on the Evaluation of BSE via the Use of Materials of Bovine Origin During the Manufacture of Vaccines. EMEA/CPMP/476/01 28 February (2001).
  • WHO. Acceptability of Cell Substrates for Production of Biologicals Report of a WHO Study Group. WHO Technical Report Series, No. 747. (1987).
  • Sutkowski EM, Gruber MF. Non-clinical safety evaluation of preventative vaccines–regulatory considerations. Business briefing. Future drug discovery. June, 32–37. (2003).
  • FDA. Good Laboratory Practice Regulations. Code of Federal Regulations, Title 21, Part 58 (21 CFR 58) (2005).
  • ICH. S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. 16 July (1997).
  • CBER, FDA. Guidance for Industry. Considerations for Reproductive Toxicity Studies for Preventative Vaccines for Infectious Disease Indications. Draft. August (2000).
  • CHMP, EMEA. Guideline on Adjuvants in Vaccines for Human Use. EMEA/CPMP/VEG/134716/2004.20 January (2005).
  • CPMP, EMEA. Notes for Guidance on Pharmaceutical and Biological Aspects of Combined Vaccines. CPMP/BWP/477/98 23 July (1998).
  • CPMP, EMEA. Notes for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products. CPMP/BWP/3088/99 24 April (2001).
  • CPMP, EMEA. Points to Consider on the Manufacture and Quality Control of Human Somatic Cell Therapy Medicinal Products. CPMP/BWP/41450/98 31 May (2001).
  • CPMP, EMEA. Points to Consider on the Development of Live Attenuated Influenza Vaccines. CPMP/BWP/2289/01 20 February (2003).
  • CPMP, EMEA. Note for Guidance on the Development of Vaccinia Virus Based Vaccines Against Smallpox. CPMP/1100/02 24 June (2002).
  • CBER, FDA. Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology. April (1985).
  • Gruber MF. Non-clinical Safety Assessment of Vaccines, in CBER Counter Terrorism Workshop: Bethesda, MD, USA (2003).
  • Opalka D, Lachman CE, MacMullen SA et al. Simultaneous quantitation of antibodies to neutralizing epitopes on virus-like particles for human papillomavirus types 6, 11, 16, and 18 by a multiplexed luminex assay. Clin. Diagn. Lab. Immunol. 10(1), 108–115 (2003).
  • Casimiro DR, Tang A, Perry HC et al. Vaccine-induced immune responses in rodents and nonhuman primates by use of a humanized human immunodeficiency virus Type 1 pol gene. J. Virol. 76(1), 185–194 (2002).
  • ICH. S7A Safety Pharmacology Studies for Human Pharmaceuticals. 8 November, San Diego, USA (2000).
  • Ledwith BJ, Manam S, Troilo PJ et al. Plasmid DNA vaccines: investigation of integration into host cellular DNA following intramuscular injection in mice. Intervirology 43(4–6), 258–272 (2000).
  • Manam S, Ledwith BJ, Barnum AB et al. Plasmid DNA vaccines: tissue distribution and effects of DNA sequence, adjuvants and delivery method on integration into host DNA. Intervirology 43(4–6), 273–281 (2000).
  • Wang Z, Troilo PJ, Wang X et al. Detection of integration of plasmid DNA into host genomic DNA following intramuscular injection and electroporation. Gene Ther. 11(8), 711–721 (2004).
  • Ledwith BJ. Preclinical development of new vaccines. Am. Pharm. Out. 6(5), 38–44 (2005).
  • WHO. Final Report. IABS Scientific Workshop on Neurovirulence Tests for Live Virus Vaccines. January 31–February 1, Geneva, Switzerland (2005).
  • Lebron JA. Formulation Changes During Development: Strategies for Bridging Preclinical Safety Assessment, in Modern Vaccine/Adjuvant Formulation. MVAF Second Circular and Provisional Conference. 15–17 September Prague, Czech Republic, (2004).
  • Pink JR, Kieny MP. 4th meeting on Novel Adjuvants Currently in/close to Human Clinical Testing World Health Organization – organisation Mondiale de la Sante Fondation Merieux, Annecy, France, 23–25 June (2003). Vaccine 22(17–18), 2097–2102 (2004).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.