Cell-Based Potency Assays

Cell-Based Potency Assay Services
Cell-based potency assays are crucial analytical tools required for releasing drug products for clinical testing and commercial use. Their availability and appropriateness have come under significant scrutiny by regulatory agencies, allowing critical opportunities to ensure regulatory compliance and efficiency. Phase-appropriate potency assays are pivotal in avoiding delays in regulatory approval or clinical hold.
With extensive experience in commercially approved products, Pharmaron offers end-to-end capabilities to develop and validate GMP-compliant cell-based potency assays for cell therapy, gene therapy, and biologics products. Our reliable cell-based potency assay services ensure that your pharmaceutical and biopharmaceutical products meet regulatory standards and are ready for market release.
Pharmaron is dedicated to supporting you through challenges at any stage of assay development, offering customized solutions for in vitro potency testing and cell-based assay development. Trust us to be your partner in achieving successful regulatory approval and commercial success.
Why Choose Pharmaron?
- Extensive experience with commercially approved products
- Comprehensive, end-to-end potency assay development and validation
- Expertise in GMP-compliant processes for cell therapy, gene therapy, and biologics
- Commitment to regulatory compliance and timely approvals
Offerings
Complex biological therapeutic products require their potency to be tested in multiple formats. Depending upon the modality, it may include evaluating the ability to transfer the gene assessed by quantifying viral copy number, infectivity assessment, or protein expression by therapeutic genes. A mechanism of action assay is also needed to decipher the biological effects that depend upon the therapeutic molecule’s nature.