Advancing cell and gene therapies requires harmonized PCR method development and validation.

As qPCR and dPCR continue to play a critical role in cell and gene therapy bioanalysis, consistent approaches to assay development and validation are essential. This white paper brings together recommendations from an industry working group to provide best practices for designing, developing, and validating PCR assays that support regulated bioanalysis across a range of cell and gene therapy applications.

Key topics include:

• Best practices for qPCR and dPCR assay development and validation
• Considerations for biodistribution, transgene expression, viral shedding, and cellular kinetics studies
• Recommendations for assay design, sample processing, extraction methods, and critical reagents
• Strategies to improve assay harmonization and support regulatory expectations for cell and gene therapy development

Developed through collaboration among experts from industry, biotechnology, pharmaceutical companies, and CROs, this publication provides a practical framework for building robust, fit-for-purpose PCR assays that support the evolving landscape of cell and gene therapy drug development.