KCAS Bio scientists contributed to an industry working group publication addressing the development and validation of quantitative PCR (qPCR) and digital PCR (dPCR) assays used in regulated bioanalysis for cell and gene therapies. The publication has been recognized as a 2026 High Impact Article by the AAPS Journal.

Published in the February 2024 issue of The AAPS Journal, the paper, “Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development,” brings together 37 experts from 24 organizations to address the need for greater harmonization in PCR assay design, development, validation, and acceptance criteria.

Three KCAS Bio scientists contributed to the working group and co-authored the publication: Carrie Vyhlidal, PhD; Manisha Diaz, PhD; and Jonathan Mercier. Their contributions support industry recommendations for qPCR, RT-qPCR, dPCR, and RT-dPCR applications in cell and gene therapy bioanalysis.

Industry Considerations for PCR-Based Bioanalysis

The paper provides practical considerations for designing and validating molecular assays used to support cell and gene therapy development, including applications such as:

  • Biodistribution
  • Transgene expression
  • Viral shedding
  • Persistence and cellular kinetics of cell therapies

The recommendations address assay design and development, critical reagents, assay platforms, and method validation. The working group also discusses how the intended context of use should guide assay design, platform selection, and validation strategies. As qPCR and dPCR continue to play important roles in the bioanalytical characterization of cell and gene therapies, industry consensus around appropriate assay development and validation practices can help support consistent, scientifically sound approaches across development programs.

Read the Publication

Read the full open-access article in The AAPS Journal: Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development | The AAPS Journal | Springer Nature Link

View the KCAS Bio Resource

The publication is also available in the KCAS Bio scientific resources library: qPCR and dPCR Assay Development for Cell & Gene Therapy

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