Validation of a Flow Cytometry-based Potency Assay for GMP-compliant Antibody Testing (Case Study)

Validation of a Flow Cytometry-based Potency Assay for GMP-compliant Antibody Testing (Case Study)

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Presented by: Anika Anker, Eurofins Poster Number: P-205-Th Poster Session: Characterizing, Bridging and Improving Bioassays Thursday, 25 Sept. at 10:30 ----- Flow cytometry is a powerful analytical technique which uses laser-based detection to characterise cellular properties, as well as to evaluate the binding and functional activity of therapeutic antibodies. One of the key advantages of this method is its ability to assess target antigens in their native conformation on the cell surface. To support the quality control of a therapeutic monoclonal antibody for stability and release testing, we developed a flow cytometry-based potency assay to quantify the binding of this antibody to its membrane-expressed target molecule. Subsequently, this method was validated in accordance with the ICH(R1, effective at that time) Q2 guideline, demonstrating great accuracy, repeatability, intermediate precision, linearity, and stability-indicating properties. This case study outlines our validation strategy and results, offering practical insights into developing robust flow cytometry assays for reliable, regulatory-compliant biologics testing.

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EurofinsEurofins Scientific is a group of international life science companies providing a unique range of analytical testing services to clients across a wide range of industries. From the food you eat to the medicines you rely on, Eurofins works with the world's largest companies to ensure that the products they supply are safe, their ingredients are authentic, and their labelling is accurate. Eurofins is a world leader in food, environmental, pharmaceutical, and cosmetic product testing and agro-science CRO services. Performing more than 450 million tests each year, Eurofins offers a portfolio of more than 200,000 analytical methods to assess the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Sponsoring Eurofins Companies Eurofins BioPharma Product Testing, eurofins.com/BPT, offers complete CMC Testing Services for the Bio/Pharmaceutical industry, including all starting materials, process intermediates, drug substances, drug product, packaging, and manufacturing support through our broad technical expertise in Biochemistry, Molecular & Cell Biology, Virology, Chemistry and Microbiology. With a global capacity of more than 200,000m2 and 46 facilities located in over 22 countries, our network of GMP laboratories and vast experience allow us to support projects of any size from conception to market. We offer three unique service models: • PSS Insourcing Solutions® • Full Time Equivalent (FTE) • Traditional fee-for-service Email: pharmatesting@bpt.eurofinseu.com (Germany) and EurofinsBiolab@bpt.eurofinseu.com (Italy) Eurofins DiscoverX, discoverx.com, is dedicated to enabling and accelerating multi-modality drug discovery and development from discovery to QC lot release. For drug discovery and development scientists, Eurofins DiscoverX is the trusted provider of product solutions that accelerate research and drug discovery programs with confidence for GPCRs, kinases, cytokine and checkpoint receptors, ion channels, epigenetics and nuclear proteins, and other target families. Eurofins DiscoverX develops and manufactures state-of-the-art assays, stable cell lines, ready-to-use kits (including bioassays), membrane preparations, enzymes, and reagents for small molecule and biologic applications.