Best practices in qPCR and dPCR validation in regulated bioanalytical laboratories
Molecular techniques are increasingly used in bioanalytical laboratories for gene and cell therapies, but due to a lack of regulatory guidance, contract research organizations rely on scientific judgment and best practices to ensure GxP compliance for preclinical and clinical studies. There is a need to provide best-practice recommendations and facilitate future regulatory guidance for the development and validation of qPCR and dPCR assays in regulated bioanalytical laboratories.
In this Meeting Report, you will explore the recommendations for qPCR/dPCR assay design, validation and method development considerations, while comparing the pros and cons of each technology for applications including biodistribution, viral shedding and gene expression analysis. The article proposes using scientific evidence to support the suitability of these methods for specific contexts and advocates for continued dialogue within the bioanalytical community and health authorities to further refine best practices for qPCR in regulated bioanalysis.
This resource is part of the Bioanalysis Zone Spotlight on bioanalytical support for AAV therapies. Click here to view the full feature.
In association with:
