Qualification of a Semi-Automated Cell-Based Potency Assay for mRNA (Case Study)

Qualification of a Semi-Automated Cell-Based Potency Assay for mRNA (Case Study)

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Presented by: Roger Müller, Eurofins Biopharma Product Testing Poster Number: P-105-W Poster Session: Antibody Products and Automation Wednesday, 24 Sept. at 15:00 ----- Cell-based potency assays rely on living cells, involve multiple pipetting steps, and require the handling of small volumes - all factors that contribute to the inherent variability within assays, between analysts, and across different days. To mitigate these challenges, we implemented semi-automation using instruments such as the Integra VIAFLO96 and Integra ASSIST PLUS. In our case study, we developed a potency expression assay in which mRNA is transfected into a suitable host cell line, and intracellular protein expression is quantified via ELISA. Following method optimization and the integration of semi-automation - necessitated by the complexity and the number of procedural steps - the method was subsequently qualified in accordance with the ICH Q2(R2) guideline, demonstrating acceptable accuracy, precision, linearity, and specificity. Semi-automation significantly enhances potency assay performance by increasing throughput and reducing analyst hands-on time, while maintaining accuracy and precision comparable to manual methods. This case study highlights the potential of modular automation to improve bioassay efficiency, reduce manual workload, and support reliable quality control in biopharmaceutical manufacturing.

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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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