Cell-Based Potency Assays

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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
In vitro potency assays and cell-based potency assays are crucial analytical tools required for releasing drug products for clinical testing and commercial use.

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.

Resources and Technical Support

An image depicting a whitepaper advertisement for Pharmaron titled "Potency Assay Development for Cell and Gene Therapy Products." It includes a thumbnail of the whitepaper cover, an RNA/DNA strand background, and a "Download Whitepaper Below" button with the Pharmaron logo. The paper also touches on genetic toxicology insights.

Potency Assay Development for Cell and Gene Therapy Whitepaper

Poster titled "Development of in vitro potency assays to evaluate early activation, Granzyme B secretion, and cytotoxicity of CAR-T cells," featuring detailed charts and graphs. The background includes purple and blue geometric patterns with the Pharmaron logo in the bottom right corner, underlining their expertise in bioanalytical development. A download button is provided below.

Development of in vitro Potency Assays to Evaluate Early Activation Poster

Promotional image for Pharmaron's "Potency Assay Guide" ebook. Left section shows the ebook cover, with icons for safety, integrity, and results. Right section has "Potency Assay" text with a "Download eBook Below" button, overlaid on a DNA strand background that hints at bioanalytical development.

View our Potency Assay for Cell and Gene Therapy Products eBook

A promotional poster displays scientific information on leveraging imaging technologies for drug potency testing in orthotopic and heterotopic tumor models. It includes text, graphs, and images related to Preclinical ADME studies. A "Download Below" button is visible, along with Pharmaron's logo.

Leveraging the IVIS imaging technologies for drug potency testing Poster