Jan Michel Falcke
Company: BioNTech
Job title: Director Global AS&T
Seminars:
Panel Discussion: Navigating the Phase Appropriate Regulatory Prospective & Expectations of Potency Assays to Meet CQAs & CPIs to De-Risk Regulatory Submissions 12:00 pm
What is the phase appropriate expectation for potency assays? Protein expression versus activity-based methods What is the feedback on potency assays when using cell lines that do not match the site of indication? Debating the need to measure the potency of each component or drug substance of an mRNA-LNP, compared to just formulated drug product…Read more
day: Conference Day One