This AAPS working group paper provides industry considerations for the design, development, and validation of qPCR and dPCR assays used in regulated bioanalysis for cell and gene therapies. Developed by 37 experts from 24 organizations, the paper addresses the lack of harmonized guidance and acceptance criteria for these platforms and presents considerations for assay design, critical reagents, and method validation. The recommendations cover applications including biodistribution, transgene expression, viral shedding, and persistence or cellular kinetics of cell therapies, with considerations specific to qPCR, RT-qPCR, dPCR, and RT-dPCR where applicable.
Read the article featured in the February 2024 edition of the AAPS Journal.
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