Module 9 2021

23/03/2021

Characterization of the product

 Components of the vaccine must be quantified, their effects demonstrated  Preservative, stabilizer, adjuvants

 Consistency lots of final commercial scale  Potency of active ingredients  Immunogenicity

 Physical characteristics  Purity, Identity, Sterility  Pyrogenicity testing  General safety testing

Vaccines 6th Edition, 2013 - By Stanley A. Plotkin, MD, Walter Orenstein, MD and Paul A. Offit, MD - Chapter 4: Vaccine manufacturing // Phillip L. Gomez, James M. Robinson and Joseph A. Rogalewicz

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What do the authorities focus upon during the technical review?

 Compliance with regulations / requirements / Note for Guidance  Manufacturing consistency and process validation  Comparability of clinical lots versus commercial lots  Purity  Specification for lot release and justification  Starting / raw materials : origin, purity, testing  Stability and shelf-life

European Union: Notice to Applicants, Vol. 2B

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