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Potency Assays for Cell & Gene Therapy Products

Potency Assay Development 

The preferred method for determining potency is a single, quantitative biological assay. However, due to the complex nature of CGT products, this approach may not always be sufficient. In this case, an alternative approach of using a non-biological assay and/or a combination of biological and non-biological assays (i.e. an assay matrix) may be used. At least one assay used to measure potency should be quantitative, and there should be scientifically sound data to correlate assay results to relevant product-specific biological activity.

Roadmap of In Vitro Potency Assays for CGT Products: Tools & Techniques 

Potency Assay Roadmap

Potency Assay Validation

Potency assay development should start as early as possible in the product’s life cycle to allow time for evaluating multiple assays, generating data on product stability and consistency, and collecting data to support correlation studies if needed. As the product advances through clinical phases, so should the potency assay with regards to demonstrating biological relevance and establishing acceptance criteria. This phase-appropriate approach allows continuous improvement and optimization of the potency assay, which will enable consistent lot release during clinical trials and streamlined regulatory submission.


Steps to Potency Assay Validation

For more information, request a download of ACF Bioservices’ Potency Assay Guide: Understanding Potency Assay Validation, FDA Requirements

Included in the guide:

  • Potency Assay Introduction
    • Why it’s so important, and where to begin
  • Regulatory Requirements
    • A review of how the USP, ICH, and CBER guidelines define potency assay parameters
  • Steps to Validation
    • How to pursue your Target Assay Profile in a phase-appropriate manner
  • Challenges in Potency Assay Development
    • Adapting unique approaches for assay development and statistical design
  • Why use a CRO?
    • How to leverage scientific expertise and compliance-ready facility and procedures
  • Case Study
    • Review of potency assay development for a late stage AAV GT product
ACF Bioservices Potency Assay Guide for Cell and Gene Therapy Products
Request Download