Improving potency assays through semi-automation
Frances Reichert, PhD, Biologics Technical Specialist Biologics, Eurofins BioPharma Product Testing Munich GmbH, frances.reichert@bpt.eurofinseu.com
As specified in the ICH Q6B guideline, potency is a critical quality attribute for biopharmaceuticals, playing a key role in quality control to ensure product safety and efficacy. Regulatory agencies emphasise that potency assays must align with a drug’s mode of action to provide physiologically relevant results. Although cell-based assays are commonly used for this purpose, they are prone to variability due to the use of living cells, assay complexity, and analyst experience, making it difficult to achieve consistent and reproducible results.
While full end-to-end automation in a GMP-regulated environment remains challenging, a modular semi-automated approach offers a highly flexible and cost-effective solution. This strategy enables increased precision and reduced variability while supporting adaptable workflows. At Eurofins BioPharma Product Testing Munich, we use semi-automated systems in our laboratories, including the recently GMP-validated Hamilton Microlab® STAR liquid handler and Integra platforms such as the VIAFLO96 and ASSIST PLUS to support method development, qualification/validation, and GMP sample routine testing.
In a case study, we used the cAMP Hunter™ Bioassay Kit to evaluate the potency of a peptide agonist and demonstrate the benefits of semi-automation. Initially, the semi-automated method using the Integra VIAFLO96 pipette showed high replicate variability and overestimated potency values compared to manual performance. However, after optimising pipetting speeds and reagent additions, the results became much more consistent, with potency recoveries of 103% and 93%, closely aligning with the expected value of 100%. This improved precision and accuracy was confirmed across the method range of 50–200%.
Semi-automation is a valuable tool for potency assays, increasing throughput and reducing analyst time without compromising accuracy or precision. However, careful optimisation of automation methods is essential to ensure effective implementation and results comparable to those achieved manually. Overall, these technologies can improve method precision and consistency, increase throughput, and reduce manual handling errors. For more information, visit: www.eurofins.de/biopharma-product-testing/biopharma-product-testing-services/large-molecules-biologics/automation-of-analytical-procedures/