Semi-automation in cell-based potency assays offers significant advantages in improving consistency and reducing hands-on time. Potency assays are essential for evaluating the biological activity of biopharmaceuticals and ensuring compliance with regulatory requirements like ICH Q6B. These assays must accurately reflect the drug’s mode of action to yield reliable, physiologically relevant results, which are vital for quality control in pharmaceutical manufacturing.
Cell-based bioassays typically involve living cells, multiple pipetting steps, and handling of small volumes, which can lead to inherent variability within assays, between analysts, and across different days. These challenges, coupled with low sample throughput, extensive analyst training, and health risks from repetitive manual pipetting, such as repetitive strain injury (RSI), can reduce efficiency and accuracy in manual bioassay methods.
To overcome the limitations of manual bioassays, Eurofins BioPharma Product Testing implemented semi-automation using advanced instruments, including the Integra VIAFLO96, Integra ASSIST PLUS, and Hamilton Microlab STAR. These tools help streamline potency assays, improving consistency, enhancing sample throughput, and increasing overall efficiency, all while maintaining high standards of accuracy and reliability.
In a case study evaluating a peptide agonist with the cAMP Hunter™ Bioassay Kit, the initial results using the semi-automated method showed high replicate variability and overestimated potency values compared to manual assays. However, after optimising pipetting speeds and reagent additions, the results significantly improved. Potency recoveries reached 103% and 93%, closely aligning with the expected 100% value, demonstrating the effectiveness of optimising automation protocols for consistent results.
Semi-automation proved to be a valuable tool for potency assays, increasing throughput and reducing analyst time without sacrificing accuracy and precision. However, careful optimisation of automation methods is essential to ensure effective implementation. This case study highlights the potential of modular automation to improve bioassay efficiency, reduce manual workload, and ensure reliable quality control in biopharmaceutical manufacturing, pointing to a promising future for assay technologies.