Potency Assays 101: How to Develop a CMC Relative Potency Assay eBook
The Relative Potency Assay for a typical biologic is usually the most complex assay in the release and stability specification. Relative Potency methods should be designed to be as simple as possible but should still reflect the mechanism of action (MOA) that is linked to the relevant biological properties of the molecule, as is required in the regulations. The more steps in an assay presents more opportunity for variation and the less precise the ultimate result may be. In some cases, multiple potency assays may be required if there are multiple MOAs of a molecule or if a full understanding of the relevant biological properties is not fully understood, as might be the case with complex cellular therapeutics.
In this eBook, we break the relative potency assay down into its constituent steps to provide the reader with an understanding of the process: assay development, data analysis & assessment of performance and validation & assay monitoring performance. Topics include assay design, cell-line selection, dose optimization, replication strategy, outlier identification and generating the final reportable relative potency results.
Feedback from external reviewers:
“A great presentation, clear and informative.”
“This e-book is very informative, and it gives the reader a very good understanding on the different steps and the overall requirements for setting up and developing a robust potency assay.”
“I wish I had this kind of explanatory e-book when I started with potency assay work.”