568
Views
33
CrossRef citations to date
0
Altmetric
Review

Quality-control issues and approaches in vaccine development

, , , , , , & show all
Pages 227-238 | Published online: 09 Jan 2014

References

  • Buckland BC. The process development challenge for a new vaccine. Nat. Med.11(4), S16–S19 (2005).
  • Plotkin SA. Vaccines: correlates of vaccine-induced immunity. Clin. Infect. Dis.47(3), 401–409 (2008).
  • Peter G, des Vignes-Kendrick M, Eickhoff TC et al. Lessons learned from a review of the development of selected vaccines. National Vaccine Advisory Committee. Pediatrics104(4 Pt 1), 942–950 (1999).
  • Sheridan C. The business of making vaccines. Nat. Biotechnol.23(11), 1359–1366 (2005).
  • ICH guideline Q7. Good manufacturing practice for active pharmaceutical ingredients. 1–49 (2000).
  • ICH guideline Q9. Quality risk management. 1–19 (2005).
  • ICH guideline Q8. Pharmaceutical development. 1–9 (2006).
  • Dellepiane N, Griffiths E, Milstien JB. New challenges in assuring vaccine quality. Bull. World Health Organ.78(2), 155–162 (2000).
  • Lebron JA, Wolf JJ, Kaplanski CV, Ledwith BJ. Ensuring the quality, potency and safety of vaccines during preclinical development. Expert Rev. Vaccines4(6), 855–866 (2005).
  • Capelle MA, Brugger P, Arvinte T. Spectroscopic characterization of antibodies adsorbed to aluminium adjuvants: correlation with antibody vaccine immunogenicity. Vaccine23(14), 1686–1694 (2005).
  • Jones LS, Peek LJ, Power J, Markham A, Yazzie B, Middaugh CR. Effects of adsorption to aluminum salt adjuvants on the structure and stability of model protein antigens. J. Biol. Chem.280(14), 13406–13414 (2005).
  • Peek LJ, Martin TT, Elk Nation C, Pegram SA, Middaugh CR. Effects of stabilizers on the destabilization of proteins upon adsorption to aluminum salt adjuvants. J. Pharm. Sci.96(3), 547–557 (2007).
  • Edwards KM. Development, acceptance, and use of immunologic correlates of protection in monitoring the effectiveness of combination vaccines. Clin. Infect. Dis.33(Suppl. 4), S274–S277 (2001).
  • Taffs RE. Potency tests of combination vaccines. Clin. Infect. Dis.33(Suppl. 4), S362–S366 (2001).
  • Postema AS, Myers MG, Breiman RF. Challenges in the development, licensure, and use of combination vaccines. Clin. Infect. Dis.33(Suppl. 4), S261–S266 (2001).
  • Gnanashanmugam D, Falkovitz-Halpern MS, Dodge A et al. Shedding and reversion of oral polio vaccine type 3 in Mexican vaccinees: comparison of mutant analysis by PCR and enzyme cleavage to a real-time PCR assay. J. Clin. Microbiol.45(8), 2419–2425 (2007).
  • Lu Z, Douthitt MP, Taffs RE, Ran Y, Norwood LP, Chumakov KM. Quantitative aspects of the mutant analysis by PCR and restriction enzyme cleavage (MAPREC). PCR Methods Appl.3(3), 176–180 (1993).
  • Diphtheria vaccine (adsorbed). In: Monograph 0443. European Pharmacopeia Commission (5th Edition).660–661. Council of Europe, Strasbourg, France (2005).
  • Schalk JA, de Vries CG, Jongen PM. Potency estimation of measles, mumps and rubella trivalent vaccines with quantitative PCR infectivity assay. Biologicals33(2), 71–79 (2005).
  • Gorringe AR, Reddin KM, Funnell SG, Johansson L, Rytkonen A, Jonsson AB. Experimental disease models for the assessment of meningococcal vaccines. Vaccine23(17–18), 2214–2217 (2005).
  • Mrkic B, Pavlovic J, Rulicke T et al. Measles virus spread and pathogenesis in genetically modified mice. J. Virol.72(9), 7420–7427 (1998).
  • Johansson L, Rytkonen A, Bergman P et al. CD46 in meningococcal disease. Science301(5631), 373–375 (2003).
  • Nomura T, Tamaoki N, Takakura A, Suemizu H. Basic concept of development and practical application of animal models for human diseases. Curr. Top. Microbiol. Immunol.324, 1–24 (2008).
  • Lal G, Balmer P, Joseph H, Dawson M, Borrow R. Development and evaluation of a tetraplex flow cytometric assay for quantitation of serum antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135. Clin. Diagn. Lab. Immunol.11(2), 272–279 (2004).
  • Lal G, Balmer P, Stanford E, Martin S, Warrington R, Borrow R. Development and validation of a nonaplex assay for the simultaneous quantitation of antibodies to nine Streptococcus pneumoniae serotypes. J. Immunol. Methods296(1–2), 135–147 (2005).
  • Smith JF, Kowalski R, Esser MT, Brown MJ, Bryan JT. Evolution of type-specific immunoassays to evaluate the functional immune response to Gardasil: a vaccine for human papillomavirus types 16, 18, 6 and 11. Hum. Vaccin.4(2), 134–142 (2008).
  • van Gageldonk PG, van Schaijk FG, van der Klis FR, Berbers GA. Development and validation of a multiplex immunoassay for the simultaneous determination of serum antibodies to Bordetella pertussis, diphtheria and tetanus. J. Immunol. Methods335(1–2), 79–89 (2008).
  • Finne J, Leinonen M, Makela PH. Antigenic similarities between brain components and bacteria causing meningitis. Implications for vaccine development and pathogenesis. Lancet2(8346), 355–357 (1983).
  • Alaedini A, Latov N. Antibodies against OspA epitopes of Borrelia burgdorferi cross-react with neural tissue. J. Neuroimmunol.159(1–2), 192–195 (2005).
  • Arigita C, Kersten GF, Hazendonk T, Hennink WE, Crommelin DJ, Jiskoot W. Restored functional immunogenicity of purified meningococcal PorA by incorporation into liposomes. Vaccine21(9–10), 950–960 (2003).
  • Kim HW, Canchola JG, Brandt CD et al. Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine. Am. J. Epidemiol.89(4), 422–434 (1969).
  • Trotter CL, Andrews NJ, Kaczmarski EB, Miller E, Ramsay ME. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet364(9431), 365–367 (2004).
  • Crotty S, Ahmed R. Immunological memory in humans. Semin. Immunol.16(3), 197–203 (2004).
  • Kelly DF, Pollard AJ, Moxon ER. Immunological memory: the role of B cells in long-term protection against invasive bacterial pathogens. JAMA294(23), 3019–3023 (2005).
  • Clutterbuck EA, Oh S, Hamaluba M, Westcar S, Beverley PC, Pollard AJ. Serotype-specific and age-dependent generation of pneumococcal polysaccharide-specific memory B-cell and antibody responses to immunization with a pneumococcal conjugate vaccine. Clin. Vaccine Immunol.15(2), 182–193 (2008).
  • Nanan R, Heinrich D, Frosch M, Kreth HW. Acute and long-term effects of booster immunisation on frequencies of antigen-specific memory B-lymphocytes. Vaccine20(3–4), 498–504 (2001).
  • McMichael AJ, Gotch FM, Noble GR, Beare PA. Cytotoxic T-cell immunity to influenza. N. Engl. J. Med.309(1), 13–17 (1983).
  • Kaufmann SH, McMichael AJ. Annulling a dangerous liaison: vaccination strategies against AIDS and tuberculosis. Nat. Med.11(4 Suppl.), S33–S44 (2005).
  • Appay V, van Lier RA, Sallusto F, Roederer M. Phenotype and function of human T lymphocyte subsets: consensus and issues. Cytometry A73(11), 975–983 (2008).
  • McElhaney JE, Xie D, Hager WD et al. T cell responses are better correlates of vaccine protection in the elderly. J. Immunol.176(10), 6333–6339 (2006).
  • Seder RA, Darrah PA, Roederer M. T-cell quality in memory and protection: implications for vaccine design. Nat. Rev. Immunol.8(4), 247–258 (2008).
  • US FDA. Guidance for Industry. PAT – A framework for innovative pharmaceutical development, manufacturing, and quality assurance. US Food and Drug Administration, 1–19 (2004).
  • Streefland M, van de Waterbeemd B, Happe H et al. PAT for vaccines: the first stage of PAT implementation for development of a well-defined whole-cell vaccine against whooping cough disease. Vaccine25(16), 2994–3000 (2007).
  • Streefland M, van de Waterbeemd B, Kint J et al. Evaluation of a critical process parameter: oxygen limitation during cultivation has a fully reversible effect on gene expression of Bordetella pertussis. Biotechnol. Bioeng.102(1), 161–167 (2008).
  • Metz B, Jiskoot W, Hennink WE, Crommelin DJ, Kersten GF. Physicochemical and immunochemical techniques predict the quality of diphtheria toxoid vaccines. Vaccine22(2), 156–167 (2003).
  • Metz B, Jiskoot W, Mekkes D et al. Quality control of routine, experimental and real-time aged diphtheria toxoids by in vitro analytical techniques. Vaccine25(39–40), 6863–6871 (2007).
  • Fedson DS. Vaccine development for an imminent pandemic: why we should worry, what we must do. Hum. Vaccin.2(1), 38–42 (2006).
  • EMEA. Committee for medicinal products for human use (CHMP).Guideline on strategies to idenitfy and mitigate risks for first-in-human clinical trials with investigational medicinal products. EMEA/CHMP/SWP/28367/07 (2007).
  • Suntharalingam G, Perry MR, Ward S et al. Cytokine storm in a Phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med.355(10), 1018–1028 (2006).
  • Farrington C, Miller E. Meningococcal vaccine trials. In: Methods in Molecular Medicine: Meningococcal Vaccines. Pollard AJ, Maiden MCJ (Eds). Humana Press, NJ, USA 371–393 (2001).
  • WHO. Recommendations for the production and control of pneumococcal conjugate vaccines. WHO Technical Report Series 927, Annex 2 (2005).
  • EMEA. Committee for medicinal products for human use (CHMP). Guideline on clinical evaluation of new vaccines. EMEA/CHMP/SWP/164653/2005 (2006).
  • European Pharmacopeia Commission. Edition 6.3. Council of Europe, Strasbourg (2009).
  • WHO. Recommendations for diphtheria, tetanus, pertussis and combined vaccines. WHO technical report series, No. 927, Annex 5 (2003).
  • Akkermans AM, Hendriksen CF, Marsman FR, van de Donk HJ. Evaluation and validation of a single-dilution potency assay based upon serology of vaccines containing diphtheria toxoid: analysis for consistency in production and testing. Dev. Biol. Stand.86, 323–324 (1996).
  • Quality risk management. In: Eudralex (Volume 4); EU guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinairy Use. Annex 20 (2008).
  • ICH Topic Q2. Validation of analytical procedures: text and methodology (2005).
  • US FDA. Guidance for Industry. Investigating out-of-specification (OOS) test results for pharmaceutical production. 1–14. US Food and Drug Administration (2006).
  • Shewhart WA. Statistical method from the viewpoint of quality control. The Graduate School, the Department of agriculture, WA, USA (1939).
  • Meiring HD, Soethout EC, de Jong AP, van Els CA. Targeted identification of infection-related HLA class I-presented epitopes by stable isotope tagging of epitopes (SITE). Curr. Protoc. Immunol. Chapter 16, Unit 16 13 (2007).
  • Wu XD, Kircher RA, McVerry PH, Malinzak DA. Characterization of post-translationally modified recombinant protein using liquid chromatography/mass spectrometry. Dev. Biol. (Basel)103, 61–67 (2000).
  • Williams JN, Skipp PJ, Humphries HE, Christodoulides M, O’Connor CD, Heckels JE. Proteomic analysis of outer membranes and vesicles from wild-type serogroup B Neisseria meningitidis and a lipopolysaccharide-deficient mutant. Infect. Immun.75(3), 1364–1372 (2007).
  • Turula VE, Kim J, Michon F, Pankratz J, Zhang Y, Yoo C. An integrity assay for a meningococcal type B conjugate vaccine. Anal. Biochem.327(2), 261–270 (2004).
  • Mawas F, Ho MM, Huskisson R, Saydam M, Corbel MJ. Physico-chemical characterisation and immunogenicity of a multi-valent candidate vaccine against non-typeable Haemophilus influenzae and Moraxella catarrhalis.Vaccine25(25), 4801–4808 (2007).
  • Frech C, Hilbert AK, Hartmann G, Mayer K, Sauer T, Bolgiano B. Physicochemical analysis of purified diphtheria toxoids: is toxoided then purified the same as purified then toxoided? Dev. Biol. (Basel)103, 205–215 (2000).
  • Rich RL, Myszka DG. Spying on HIV with SPR. Trends Microbiol.11(3), 124–133 (2003).
  • Turbyfill KR, Kaminski RW, Oaks EV. Immunogenicity and efficacy of highly purified invasin complex vaccine from Shigella flexneri 2a. Vaccine26(10), 1353–1364 (2008).
  • Jiang G, Joshi SB, Peek LJ et al. Anthrax vaccine powder formulations for nasal mucosal delivery. J. Pharm. Sci.95(1), 80–96 (2006).
  • Amorij JP, Meulenaar J, Hinrichs WL et al. Rational design of an influenza subunit vaccine powder with sugar glass technology: preventing conformational changes of haemagglutinin during freezing and freeze-drying. Vaccine25(35), 6447–6457 (2007).
  • Jedrzejas MJ, Lamani E, Becker RS. Characterization of selected strains of pneumococcal surface protein A. J. Biol. Chem.276(35), 33121–33128 (2001).
  • Salnikova MS, Joshi SB, Rytting JH, Warny M, Middaugh CR. Physical characterization of Clostridium difficile toxins and toxoids: effect of the formaldehyde crosslinking on thermal stability. J. Pharm. Sci.97(9), 3735–3752 (2008).
  • Belnap DM, McDermott BM Jr, Filman DJ et al. Three-dimensional structure of poliovirus receptor bound to poliovirus. Proc. Natl Acad. Sci. USA97(1), 73–78 (2000).
  • Claassen I, Meylis J, van der Ley P et al. Production, characterization and control of a Neisseria meningitidis hexavalent class 1 outer membrane protein containing vesicle vaccine. Vaccine14(10), 1001–1008 (1996).
  • Lorent E, Bierau H, Engelborghs Y, Verheyden G, Bosman F. Structural characterisation of the hepatitis C envelope glycoprotein E1 ectodomain derived from a mammalian and a yeast expression system. Vaccine26(3), 399–410 (2008).
  • McHugh CA, Tammariello RF, Millard CB, Carra JH. Improved stability of a protein vaccine through elimination of a partially unfolded state. Protein Sci.13(10), 2736–2743 (2004).
  • Zheng Y, Lai X, Bruun SW et al. Determination of moisture content of lyophilized allergen vaccines by NIR spectroscopy. J. Pharm. Biomed. Anal.46(3), 592–596 (2008).
  • Lai X, Zheng Y, Sondergaard I et al. Determination of aluminium content in aluminium hydroxide formulation by FT-NIR transmittance spectroscopy. Vaccine25(52), 8732–8740 (2007).
  • Lamb DH, Summa L, Lei QP. Capillary electrophoretic analysis of meningococcal polysaccharide–diphtheria toxoid conjugate vaccines. Dev. Biol. (Basel)103, 251–258 (2000).
  • Mellado MC, Franco C, Coelho A, Alves PM, Simplicio AL. Sodium dodecyl sulfate-capillary gel electrophoresis analysis of rotavirus-like particles. J. Chromatogr. A1192(1), 166–172 (2008).
  • Stewart-Tull DE, Bleakley CR, Galloway TS. Characteristics of Vibrio cholerae proteinases: potential, candidate vaccine antigens. Vaccine22(23–24), 3026–3034 (2004).
  • Delgado M, Yero D, Niebla O et al. Lipoprotein NMB0928 from Neisseria meningitidis serogroup B as a novel vaccine candidate. Vaccine25(50), 8420–8431 (2007).
  • Khemiri A, Galland A, Vaudry D et al. Outer-membrane proteomic maps and surface-exposed proteins of Legionella pneumophila using cellular fractionation and fluorescent labelling. Anal. Bioanal. Chem.390(7), 1861–1871 (2008).
  • Smith TG, Lim JM, Weinberg MV, Wells L, Hoover TR. Direct analysis of the extracellular proteome from two strains of Helicobacter pylori. Proteomics7(13), 2240–2245 (2007).
  • Metz B, Kersten GF, Baart GJ et al. Identification of formaldehyde-induced modifications in proteins: reactions with insulin. Bioconjug. Chem.17(3), 815–822 (2006).
  • Davidsen J, Rosenkrands I, Christensen D et al. Characterization of cationic liposomes based on dimethyldioctadecylammonium and synthetic cord factor from M. tuberculosis (trehalose 6,6´-dibehenate)-a novel adjuvant inducing both strong CMI and antibody responses. Biochim. Biophys. Acta1718(1–2), 22–31 (2005).
  • Meyer BK, Ni A, Hu B, Shi L. Antimicrobial preservative use in parenteral products: past and present. J. Pharm. Sci.96(12), 3155–3167 (2007).

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.