Connecting ATMP Discovery to Commercial: Improving Manufacturability Complimentary Learning Level: Intermediate Session Length: 1.5 hour Peter Marks of the FDA has spoken a number of times about the high number of clinical...
The SARS-CoV-2 worldwide pandemic has presented a significant challenge to business continuity for pharmaceutical manufacturing. It has led to Industry re-assessing the virus control framework, and in particular, any challenges that this may present to the mitigations currently in place. This presentation will focus on the SARS-CoV-2 situation and factors to be assessed in a GMP Biopharmaceutical manufacturing facility and whether they present a secure virus mitigation strategy to protect the product from contamination from this and other viruses.