Quantitative Measurement of Fc-mediated ADCC & ADCP Activity of Therapeutic Antibodies Using a Robust, Universal Cell-based Assay Platform

Quantitative Measurement of Fc-mediated ADCC & ADCP Activity of Therapeutic Antibodies Using a Robust, Universal Cell-based Assay Platform

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Presented by: Monserrat Vazquez Rojas, Eurofins DiscoverX Poster Number: P-102-W Poster Session: Antibody Products and Automation Wednesday, 24 Sept. at 15:00 ----- The clinical success of a broad range of biologics has driven the development of diverse immunomodulatory agents with unique mechanisms of action (MOA) targeting novel antigens. Regulatory guidelines now require evaluation of antibody effector functions, such as antibody-dependent cell-mediated cytotoxicity (ADCC), particularly for lot-release assays that measure immune cell-mediated killing directly rather than surrogate endpoints. Additionally, antibody-dependent cellular phagocytosis (ADCP) has become a key MOA, especially for IND-enabling studies involving antibodies with modified Fc regions. To address these needs, Eurofins DiscoverX® developed the KILR® cytotoxicity assay platform that accurately measures the killing of antigen-expressing target cells in co-culture with immune effector cells. This dye-free, radioactivity-free platform leverages the validated Enzyme Fragment Complementation (EFC) technology and supports various immune-mediated killing mechanisms, including ADCC, CDC, ADCP, and T-cell redirection. Here, we showcase the KILR platform’s versatility across multiple antigens (e.g., HER2, CD20, CD19) and effector cell types. Combined with engineered KILR CD16 Effector Cells, the KILR platform provides robust, reproducible assay performance necessary for testing in the quality-controlled environment for commercial lot release. This platform also quantifies ADCP cost-effectively, simplifying traditional FACS or imaging-based workflows. To ensure assay reproducibility, many KILR target cell models are now available in an assay-ready format, with phase-appropriate qualification data supporting their suitability for potency and screening applications.

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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.

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