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Vaccine Potency Assays

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Vaccine Analysis: Strategies, Principles, and Control

Abstract

Historically, vaccines have predominantly been manufactured through complex biological processes (growth in embryonic chicken eggs, bacterial fermentation, and mammalian cell culture) that can be challenging to control and reproduce. Although the introduction of Quality by Design principles is changing the “the process is the product” mindset, the development of appropriate release assays remains a critical element in ensuring the safety and efficacy of a vaccine throughout its shelf life. The development of relevant and robust potency assays requires careful consideration of the nature of the protective immune response to the targeted antigen as well as a detailed understanding of the structural features of the antigen that elicit the protective response.

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Author information

Authors and Affiliations

  1. Technical Development, Novartis Vaccines, Siena, Italy

    Todd Ranheim

  2. Bioassays and Impurity Testing, Pfizer, St. Louis, MO, USA

    Ned Mozier

  3. Technical Development, Novartis Vaccines, Columbia, MD, USA

    William Egan

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  1. Todd Ranheim
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  2. Ned Mozier
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  3. William Egan
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Corresponding author

Correspondence to Todd Ranheim .

Editor information

Editors and Affiliations

  1. Apex, North Carolina, USA

    Brian K. Nunnally

  2. Pfizer BioTherapeutics Pharmaceutical Sc, Pearl River, New York, USA

    Vincent E. Turula

  3. Sitrin Solutions, Lafayette Hill, Pennsylvania, USA

    Robert D. Sitrin

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Ranheim, T., Mozier, N., Egan, W. (2015). Vaccine Potency Assays. In: Nunnally, B., Turula, V., Sitrin, R. (eds) Vaccine Analysis: Strategies, Principles, and Control. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-45024-6_13

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