Module 9 2024

03/09/2024

Vaccine Manufacturing Process - Lengthy and Complex

May not be fully characterised

Often combined formulations: multiple Antigens, Adjuvants

Labile molecules: limited shelf-life, cold chain validated holding times

Sterile & injectable

(but increasingly well defined e.g. mRNA)

Secondary production

Primary production

Raw material reception

Shipping distribution

Bulk

Conjugation

Formulation

Filling

Lyophilisation

Packaging

Release

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Process : from 12 months to >36 months from reception of raw materials to release (vast majority 18 – 24 months)

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Characterization of the Vaccine 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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