Rebecca Malott
Company: Providence Therapeutics
Job title: Senior Manager, Analytical
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
Optimization & Implementation of a Capillary Gel Electrophoresis Method for Analysis of mRNA Integrity 9:30 am
Developing and optimizing of a CGE method for routine analysis of drug substance and drug product samples for mRNA integrity Effectively implementing and qualifying the optimized method at a CDMO partner Stability monitoring of mRNA integrity with CGE *New Data*Read more
day: Conference Day One