eChalk Talk: Bioanalytical Strategy for PK Assessments of ATMPs

The emergence of advanced therapeutic medicinal products (ATMPs), such as cell and gene therapies, has led to the increased utilization of specialized technology platforms in regulated bioanalysis. In this eChalk Talk, we will discuss platforms that are used in determining pharmacokinetics (PK) of ATMPs including qPCR, and flow cytometry. We will also highlight some of the key considerations for development and validation of these types of PK assays to support ATMP drug development.