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Chapter 12 : Pneumococcal Vaccines: Manufacture and Quality Control for Product Release

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Pneumococcal Vaccines: Manufacture and Quality Control for Product Release, Page 1 of 2

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Abstract:

The first industrially produced pneumococcal polysaccharide (PS) vaccine was made under contract from NIAID to Eli Lilly and Company. The source of the strains for this vaccine was the American Type Culture Collection (ATCC), which in essence generated, characterized, and maintained the master seeds. Pneumococcal identity testing should include analyses of colony morphology, Gram staining, and the ability of the organism to ferment insulin and to be lysed in the bile solubility test, as well as its sensitivity to optochin. Personnel involved with production and control should be satisfactorily trained on the standard operating procedures for dealing with emergencies arising from accidental spillage, leakage, or other possible events that may disseminate pneumococcal organisms. All these personnel should maintain records of this training and include records of being vaccinated with a licensed pneumococcal vaccine. PS identification can take the form of a serological method using type-specific antisera. The assay should not only identify the specific type of the PS but also rule out that the PS reacts with any of the other sera, thus demonstrating specificity. Nuclear magnetic resonance is being employed on an ever-increasing scale, not only to identify, characterize, and quantify the particular PS but also to monitor each lot for various impurities, such as the most frequent contaminant, the C-polysaccharide. The efficacy and effectiveness of pneumococcal conjugate vaccines have been difficult to establish with well-controlled clinical trials and will become more complicated in the future.

Citation: Blake M. 2008. Pneumococcal Vaccines: Manufacture and Quality Control for Product Release, p 175-182. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch12

Key Concept Ranking

Pneumococcal Conjugate Vaccine
0.55781436
High-Performance Liquid Chromatography
0.47516453
Enzyme-Linked Immunosorbent Assay
0.423298
0.55781436
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References

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1. Abeygunawardana, C.,, T. C. Williams,, J. S. Sumner, and, J. P. Hennessey, Jr. 2000. Development and validation of an NMR-based identity assay for bacterial polysaccharides. Anal Biochem. 279:226240.
2. Austrian, R. 1976. The Quellung reaction, a neglected microbiologic technique. Mt. Sinai J. Med. 43:699709.
3. Avery, O. T., and, W. F. Goebel. 1929. Chemo-immunological studies on conjugated carbohydrate-proteins. II. Immunological specificity of synthetic sugar-protein antigen. J. Exp. Med. 50:533550.
4. Avery, O. T., and, W. F. Goebel. 1931. Chemo-immunological studies on conjugated carbohydrate-proteins. V. The immunological specificity of an antigen prepared by combining the capsular polysaccharide of type 3 pneumococcus with foreign protein. J. Exp. Med. 54:437447.
5. Bednar, B., and, J. P. Hennessey. 1993. Molecular size analysis of capsular polysaccharide preparations from Steptococcus pneumoniae. Carbohydr. Res. 243:115130.
6. Blake, F. G. 1917. Methods for the determination of pneumococcus types. J. Exp. Med. 26:6780.
7. Cole, R. 1913. Treatment of pneumonia by means of specific serums. J. Am. Med. Assoc. 61:663666.
8. Cole, R., and, H. F. Moore. 1917. The production of antipneumococcic serum. J. Exp. Med. 26:537561.
9. Dochez, A. R., and, O. T. Avery. 1917. The elaboration of specific soluble substance by pneumococcus during growth. J. Exp. Med. 26:477493.
10. European Directorate for the Quality of Medicines and Healthcare. 2002. European Pharmacopoeia, p. 22052206. European Directorate for the Quality of Medicines and Healthcare, Strasbourg, France.
11. German, R. J.,, A. S. Jones, and, M. Nadarajah. 1961. Polysaccharides of Mycobacterium phlei. Nature 189:10081009.
12. Giannini, G.,, R. Rappuoli, and, G. Ratti. 1984. The amino-acid sequence of two non-toxic mutants of diphtheria toxin: CRM45 and CRM197. Nucleic Acids Res. 12:40634069.
13. Gotschlich, E. C.,, I. Goldschneider, and, M. S. Artenstein. 1969. Human immunity to the meningococcus. IV. Immunogenicity of group A and group C meningococcal polysaccharides in human volunteers. J. Exp. Med. 129:13671384.
14. Heidelberger, M., and, O. T. Avery. 1923. The soluble specific substance of pneumococcus. J. Exp. Med. 38:7379.
15. Jones, A. S. 1953. The isolation of bacterial nucleic acids using cetyltrimethylammonium bromide (Cetavlon). Biochim. Biophys. Acta 10:607612.
16. Jones, C. 2005. NMR assays for carbohydrate-based vaccines. J. Pharm. Biomed. Anal. 38:840850.
17. Kim, J. S.,, E. R. Laskowich,, R. G. Arumugham,, R. E. Kaiser, and, G. J. MacMichael. 2005. Determination of saccharide content in pneumococcal polysaccharides and conjugate vaccines by GC-MSD. Anal. Biochem. 347:262274.
18. Kim, J. S.,, E. R. Laskowich,, F. Michon,, R. E. Kaiser, and, R. G. Arumugham. 2006. Monitoring activation sites on polysaccharides by GC-MS. Anal. Biochem. 358:136142.
19. Pappenheimer, A. M., Jr.,, T. Uchida, and, A. A. Harper. 1972. An immunological study of the diphtheria toxin molecule. Immunochemistry 9:891906.
20. Rappuoli, R. 1983. Isolation and characterization of Corynebacterium diphtheriae nontandem double lysogens hyperproducing CRM197. Appl. Environ. Microbiol. 46:560564.
21. Rappuoli, R.,, J. L. Michel, and, J. R. Murphy. 1983. Restriction endonuclease map of corynebacteriophage ωctox+ isolated from the Park-Williams no. 8 strain of Corynebacterium diphtheriae. J. Virol. 45:524530.
22. Sanborn, W. R.,, Z. Bencić,, B. Cvjetanović,, E. C. Gotschlich,, T. M. Pollock, and, J. E. Sippel. 1972. Trial of a serogroup A meningococcus polysaccharide vaccine in Nigeria. Progr. Immunobiol. Stand. 5:497505.
23. Sweeney, J. A.,, J. S. Sumner, and, J. P. Hennessey, Jr. 2000. Simultaneous evaluation of molecular size and antigenic stability of PNEUMOVAX 23, a multivalent pneumococcal polysaccharide vaccine. Dev. Biol. (Basel) 103:1126.
24. Talaga, P.,, S. Vialle, and, M. Moreau. 2002. Development of a high-performance anion-exchange chromatography with pulsed-amperometric detection based quantification assay for pneumococcal polysaccharides and conjugates. Vaccine 20:24742484.
25. Uchida, T.,, A. M. Pappenheimer, Jr., and, A. A. Harper. 1972. Reconstitution of diphtheria toxin from two nontoxic cross-reacting mutant proteins. Science 175:901903.
26. U.S. FDA Center for Biologics Evaluation and Research. 1999. Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product. U.S. FDA Center for Biologics Evaluation and Research, Rockville, MD.
27. Xu, Q.,, C. Abeygunawardana,, A. S. Ng,, A. W. Sturgess,, B. J. Harmon, and, J. P. Hennessey, Jr. 2005. Characterization and quantification of C-polysaccharide in Streptococcus pneumoniae capsular polysaccharide preparations. Anal. Biochem. 336:262272.

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