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.
The Pennsylvania Attorney General’s Office Updates Ransomware Attack Incident
On September 17, the Pennsylvania Attorney General’s Office posted the following update to a ransomware attack it initially disclosed on August 11. HARRISBURG — The
