Draft guidance from the FDA suggests increased significance in understanding the relationship between other CQAs and potency to provide so-called “Potency Assurance.”. Understanding the potential relationship between potency and other CQAs and how this lead to Potency Assurance is discussed through examples. The evolution of potency assays for ATMPs are discussed and their development in the lifecycle are elaborated upon. Changes to assays and assays’ matrices are discussed using examples and the implications to potency assessment is discussed. Evolution of the entire control strategy for an ATMP evolves and is discussed in a phase dependent manner. As suggested in the Draft FDA guidance (Dec 2023), changes to the method will occur and consideration of other attributes should also be made. Potency is one CQA, but it does not exist in isolation. The paradigm for potency considerations of future products will change and be supportable by diverse data sets.
Learning Objectives:
Understand what Potency Assurance is; Understand how non-potency CQAs affect Potency Assurance; Understand phase dependent considerations to this process.
