This article is recognized as a 2026 High Impact Article by the AAPS Journal.
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 need for greater harmonization in assay design, validation, and acceptance criteria for these platforms.
Three KCAS Bio scientists contributed to the working group and co-authored this publication: Carrie Vyhlidal, PhD, Manisha Diaz, PhD and Jonathan Mercier. Their contributions support the paper’s industry-focused recommendations for qPCR, RT-qPCR, dPCR, and RT-dPCR applications, including biodistribution, transgene expression, viral shedding, and persistence or cellular kinetics of cell therapies.
The paper provides practical considerations for assay design, critical reagents, and method validation, with recommendations tailored to the analytical challenges associated with cell and gene therapy bioanalysis.
Read the article featured in the February 2024 edition of the AAPS Journal.
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