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Potency Testing

We deliver comprehensive potency testing solutions that help you advance your research meeting the strict requirements of modern therapeutic modalities.

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We deliver comprehensive potency testing solutions

Potency Testing

Potency testing is an essential part of the drug development process that assesses a drug candidate’s biological activity, the drug’s ability to elicit the intended therapeutic effect, and ensure its quality, safety and efficacy.

How we can help

With a proven track record and partnerships across multiple pharmaceutical companies, we support your needs in potency testing with ligand-binding and cell‑based technology platforms, expert and tailored laboratory services, and full regulatory compliance,

Our potency testing solutions focus on:

  • Efficacy & Safety assessment: Ensure a drug delivers consistent therapeutic effect without adverse effects.
  • Quality Control: Assessing the stability and quality of a drug throughout manufacturing, while safeguarding against activity loss.
  • Regulatory Compliance: Collecting critical data required by regulatory bodies such as the FDA and EMA, proving the drug's quality and consistency for approval and release.

 

Our Potency Testing Solutions

  • CRO SERVICES
    Our QC services are designed to ensure the highest standards of quality and compliance. We support drug development by developing potency assays tailored to your product, validating or qualifying assays for QC lot release and stability testing, and providing routine GMP-compliant analysis for lot release, stability studies, and in-process testing. With our expertise and controlled GMP environment, we deliver reliable results that meet both your quality and regulatory requirements.

    QC Services

  • CRO SERVICES
    Our Bioanalytical Services have extensive experience creating, qualifying, and performing reliable, standardized bioassays that reflect the product’s mechanism of action. Using our cell-based iLite Reporter gene assays, we can help perform non-GMP analyses of your biologics and biosimilar samples.

    Bioanalytical Services

  • CELL-BASED BIOASSAYS

    Our iLite cell-based reporter gene assays provide reliable, MoA-reflective tools for drug development and quality control. They are available as ready-to-use off-the-shelf assays or customized for your marker of choice. With their robust design and proven performance, iLite assays offer consistent, reproducible results that streamline potency testing and accelerate decision-making.

    Luciferase Reporter Assays

  • CELL-BASED BIOASSAYS

    Our iLite ADCC and ADCP Bioassay portfolio provides a sensitive, reliable, and convenient reporter gene-based system for measuring ADCC and ADCP in vitro. These assay-ready cell lines deliver reduced variability, rapid setup, and robust performance by combining engineered effector cells with target cells. Their versatility makes them highly suited for antibody screening, characterization, stability, and potency studies, including lot release testing.

    ADCC & ADCP Assays

  • CELL-BASED BIOASSAYS

    Our iLite CDC Bioassay platform provides a sensitive, reporter-gene-based system to measure antibody-mediated cell lysis via the complement pathway. These assay delivers quantitative, reproducible results without the need for radioactivity or complex workflows.

    Supplied in an assay-ready format, the assays are ideal for antibody screening, comparability studies, and potency or lot release testing.

    CDC Assays

  • CELL-BASED BIOASSAYS

    Our iLite T-Cell Activation platform is a reporter-gene-based assay that quantifies antibody-induced T cell activation via CD3 engagement. Effector cells engineered to mimic TCR/CD3 signaling generate luminescence when cross-linked by antibody and target cells; the signal correlates with activation strength.

    Delivered in assay-ready format, the system reduces variability and streamlines workflows. It is ideal for screening biologics, potency, and lot release testing.

    T-Cell Activation Assays

  • CUSTOM DEVELOPMENT
    In addition to our off-the-shelf products, we develop custom assays for a wide range of targets. Using Svar's iLite technology, we create unique, mode of action-reflective solutions tailored to fit the specific needs of your compound.

    Custom cell line development

Contact our team of experts

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