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

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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
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