eChalk Talk: Best Practices for the Development and Validation of qPCR and ddPCR Assays hosted by BioAgilytix

Description

The emergence and evolution of cell and gene therapy has led many bioanalytical laboratories to implement qPCR and/or ddPCR to support preclinical and clinical assays. While there is a lack of regulatory guidance on how to approach these assays, discussions have already started in the community on harmonizing the approach on the development and validation of qPCR/ddPCR assays. This talk will cover best practices and what should be considered when developing and validating such assays.