Potency

Potency
Demonstrating Therapeutic Activity with Confidence
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Potency is one of the most critical quality attributes for biologics and often the most complex to assess. Minaris Advanced Testing provides custom-developed, regulatory-compliant potency testing to support the release, comparability and stability programs for cell therapies, viral vectors, viral vaccines, recombinant proteins and monoclonal antibodies.

Whether your mechanism of action is transgene expression, cytolytic activity, enzyme replacement, cell proliferation, or vector delivery efficiency, we design and qualify assays that provide meaningful insight into biological function and meet global regulatory expectations.

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Potency Assay Capabilities

Our scientists work collaboratively with sponsors to design and validate potency assays tailored to each product’s specific mode of action and indication. We offer both custom development and assay transfer/qualification of sponsor-provided methods.

Common assay formats include:

Cell-based functional assays

(e.g., cytotoxicity, proliferation, enzyme replacement, cytokine release, immunomodulation)

Reporter gene assays

(e.g., for LVV/AAV-mediated expression)

Transduction efficiency and expression assays

Binding assays

(e.g., ELISA, FACS)

Quantitative PCR and droplet digital PCR

(for expression quantification)

Fit-for-Purpose Design Across Product Types

Potency methods can be developed in parallel with product development to reduce time to IND and support long-term comparability strategies.

Our potency testing services support a wide range of modalities:

  • Autologous and allogeneic cell therapies

  • Viral vector gene therapies (AAV, LVV and other platforms)

  • Viral vaccines

  • CAR-T and TCR-T therapies

  • Gene-modified cells

  • AAV and LVV gene therapies

  • Recombinant proteins and mAbs

Assay Validation & Regulatory Readiness

Minaris supports ICH Q2-compliant validation of potency methods for clinical and commercial programs. We also provide assay lifecycle management, including requalification and periodic review as your program advances. Our services include:

  • Assay development and optimization
  • Qualification and bridging studies
  • Validation protocol design and execution
  • System suitability and trending setup
  • Support for regulatory submission packages
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Whether you need GMP release testing for a commercial therapy or exploratory analysis for an early-phase asset, we’re here to help. Access our full testing catalogue or submit a sample request today.

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Accurate, timely, and compliant testing is critical to advancing complex therapies. Minaris Advanced Testing delivers a comprehensive suite of GMP biosafety and characterization services designed to support every stage of your program, from early research through IND, clinical and commercial requirements. Our team provides the experience, responsiveness and support you need. Get in touch today.

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