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28th November 2022
For cell-based veterinary medicinal products it is important to identify and link the biological activity of the viable cells, i.e. their mechanism of action, to the intended clinical indication. However, the complex biology of cells and the fact that they may exert multiple biological effects in the recipient can make it difficult to fully uncover and define a mechanism of action and subsequently determine critical potency-related attributes to test. Nevertheless, a potency assay should be able to detect clinically meaningful changes in the quality and/or quantity of the active ingredient in a cell-based veterinary medicinal product and should also serve as stability-indicating parameter.
Therefore, the aim of this guideline is to provide guidance on the requirements for developing and implementing a suitable potency assay or a combination of assays, which is linked to relevant biological properties of the cell-based product and further to clinical efficacy.
Comments should be provided using this template and sent to Vet-Guidelines@ema.europa.eu by 28 February 2023.
The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public and targeted consultations.