Understanding quantitative polymerase chain reaction bioanalysis issues before validation planning: Japan Bioanalysis Forum discussion group

Investigating the biodistribution of cell and gene therapy products may play an important role in evaluating their safety and pharmacology. As quantitative polymerase chain reaction (qPCR) is often used for these analyses, it is essential to improve the reliability of bioanalysis performed using qPCR. In this report, the authors discuss the use of qPCR in nonclinical studies, as it can be used to detect target DNA/RNA and it is quantitative and applicable for long-term analysis. The authors also discuss points to consider during bioanalysis using qPCR and present appropriate validation items and their criteria. The authors anticipate the discussion provided herein to contribute to the development of validation and sample analysis for pharmaceuticals analyzed using qPCR.

Automated summary

This report discusses the importance of using quantitative polymerase chain reaction (qPCR) in bioanalysis and the need to improve its reliability. qPCR can detect target DNA/RNA and provides quantitative and long-term analysis. The authors also provide considerations and validation criteria for bioanalysis using qPCR. The discussion in this report is expected to contribute to the development of validation and sample analysis for pharmaceuticals analyzed using qPCR.