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Recommendations on qPCR/ddPCR assay validation by GCC.

Mark Wissel1, Martin Poirier2, Christina Satterwhite3

  • 1Eurofins Viracor BioPharma, Lenexa,Kansas, USA.

Bioanalysis
|June 15, 2022
PubMed
Summary
This summary is machine-generated.

The Global CRO Council in Bioanalysis provides guidance for quantitative PCR (qPCR) and digital droplet PCR (ddPCR) assay validation. This white paper harmonizes validation approaches and SOP development for regulated bioanalysis.

Keywords:
GCCcell therapyddPCRdigital droplet polymerase chain reactiongene therapyglobal CRO council in bioanalysisqPCRquantitative polymerase chain reactionregulated bioanalysisvaccine validation

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Area of Science:

  • Biotechnology and Pharmaceutical Sciences
  • Molecular Biology Techniques
  • Regulatory Science in Bioanalysis

Background:

  • Quantitative PCR (qPCR) and digital droplet PCR (ddPCR) are increasingly utilized in bioanalytical laboratories for gene therapy, cell therapy, and vaccine research.
  • Contract Research Organizations (CROs) are actively involved in developing and validating qPCR and ddPCR assays.
  • There is a notable lack of regulatory guidelines for ddPCR and limited guidance for qPCR in regulated bioanalysis.

Purpose of the Study:

  • To establish a consensus on essential validation parameters for qPCR and ddPCR assays.
  • To propose a harmonized strategy for the validation of these molecular assays.
  • To promote consistent development of Standard Operating Procedures (SOPs) for bioanalytical laboratories.

Main Methods:

  • The Global CRO Council in Bioanalysis (GCC) convened experts to address the need for regulatory guidance.
  • A white paper was developed outlining consensus points and recommendations.
  • The paper focuses on validation parameters, harmonization, and SOP development for qPCR/ddPCR.

Main Results:

  • A consensus was reached on key validation parameters for qPCR and ddPCR assays.
  • A harmonized approach to assay validation has been proposed.
  • Recommendations for consistent SOP development are provided.

Conclusions:

  • The white paper offers critical guidance for the regulated bioanalytical use of qPCR and ddPCR.
  • Harmonized validation and SOPs will enhance data reliability and regulatory compliance.
  • This initiative addresses a significant gap in regulatory oversight for advanced molecular techniques.