2024 AAPS Journal White Paper: qPCR & dPCR Method Development and Validation

Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development

This white paper, published in The AAPS Journal, is the product of a consortium of industry experts, including our own Mark Wissel, PhD, and Manish Diaz, PhD., recognizing the limited regulatory guidance available for qPCR and dPCR bioanalysis in drug development.  It provides considerations on assay design, development, and validation testing for PCR assays that are used to support cell and gene therapy development.