By Aryo Nikopour, Senior Vice President, Scientific & Technical Services, Nitto Avecia Pharma Services and Ming Li, Ph.D., Principle Scientist and Team Lead in Biopharmaceutical Development, Nitto Avecia Pharma Services
Cell-based potency assays use live cells to mimic biological reactions in the body, providing both quantitative and relevant responses. They are generally preferred by regulatory agencies.1
When designing cell-based potency assays, consider the following method requirements and attributes.
Since potency is the critical quality attribute, the method should be developed to reflect the Mechanism Of Action and give insight into how the product functions at a molecular level. If MOA is not clear, especially at the beginning of the product development, you may need to explore multiple assay formats.
The cell-based potency assay must measure changes in product activity to detect the degraded form of the product. In other words, it should be stability indicating. Performance requirements such as precision and accuracy are the critical method attributes that need to be established during QC method development.
From an operational point of view, it's always desirable to have QC methods with faster data turnaround times and higher throughput. Also, the method should be easy to operate and transfer, with procedures that are streamlined to reduce variability and risk for error.
Once established, the method requirements and attributes built into the cell-based potency assay will guide decision making during method development.