Director of CMC Bioanalytical, BioAgilytix
BIOGRAPHY
The emergence of advanced therapy medicinal products (ATMPs) including cell therapies, has led to many bioanalytical laboratories implementing qPCR and/or newer technologies like digital PCR for bioanalytical and CMC assays to support regulated studies. In this presentation, important aspects and best practices will be addressed including assay design, validation parameters and acceptance criteria for assays used in support of cell therapy programs.