A precise, dependable, and consistent demonstration of the biological activity of the active component at the level of the drug substance and/or drug product is provided by appropriately developed potency assays. In theory, the outcome of a potency assay should guarantee that the amount of the active ingredient is consistent from batch to batch and sufficient to elicit a significant reaction. As a result, the potency assay needs to be able to identify changes in the quantity of an active ingredient in a human dose of a product that are clinically significant. Potency and immunological evaluation can vary depending on the purpose and type of medicine.
In vivo or in vitro assays can be used to measure the potency (the quantitative measure of biological activity) of cell-based immunotherapy treatments. A defined biological effect that is as near as possible to the mechanism(s) of action/clinical response should serve as the foundation for a potency assay that has been properly verified. In order to show that the test sample is biologically active, substitutes for potency may be produced. Special considerations must be made in the development and validation of such assays for cell-based immunotherapy therapies.
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