Manufacturing & Analytical Characterization
Jeff Patrick, PhD (he/him/his)
Senior Director of GMP Operations
BioAgilytix - Durham, NC
Durham, North Carolina
Description: Advanced Therapeutic Medicinal Products (ATMPs) – AAVs, lipid nanoparticles and other – are among the highest growth areas in biopharmaceuticals with complex mechanisms of action (MOA). As a result, potency assays are critical to their control strategy and are an expectation of global regulatory agencies. These products and their methods must change through their lifecycle to adapt per ICH Q12 guidance. Case studies using ELISAs, Flow Cytometry, and ddPCR/qPCR as readout of cell-based assays for ATMPs will be discussed.