Reducing Regulatory Risks in PCR Assays for Bioanalytical Validation

Reducing regulatory risks in PCR assays for bioanalytical validation — adapting current pharmacokinetic guidance

Cell and gene therapies continue to expand rapidly with novel products advancing in clinical development. It has become increasingly essential to use bioanalytical testing, like polymerase chain reaction (PCR)-based methods that determine the safety and efficacy and successful development of these drugs. However, there is no set regulatory guidance for validation of PCR assays for cell and gene therapies.

This white paper will examine the similarities and differences in validation criteria as a means of assessing potential future risks for current PCR validation parameters.