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Designing Robust Lyophilization Processes for Biologicals

Roughly 33% of unique biologicals in the FDA’s purple book are freeze-dried or lyophilized. This is notable with monoclonal antibodies, nearly a quarter of which were lyophilized in 2020. However, variable equipment and lyophilization processes can cause dissimilarities and failures in products. Brecht Vanbillemont, a senior scientist at Coriolis Pharma, emphasises the need for quality design approaches, as well as a focus on the primary drying phase in lyophilization.

Source: www.genengnews.com –

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