Module 9 2021

23/03/2021

Specificities of vaccine manufacturing

 Vaccine production relies on complex processes due to the nature of the products we manufacture (i.e. biological products)  Labile molecules: limited shelf-life, cold chain validated holding times  Not fully characterized molecules  Sterile & injectable  Often combined formulations: multiple Antigens, Adjuvants  Interactions, interferences, …

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A lengthy Vaccine Manufacturing Process

Primary production Secondary 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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