What is comparability testing of biologics?
A sponsor may be able to demonstrate product comparability between a biological product made after a manufacturing change and a product made before implementation of the change through different types of analytical and functional testing without additional clinical studies. The agency may determine that the two products are comparable if the results of the comparability testing demonstrate that the manufacturing change does not affect safety, identity, purity, or potency. For more information see FDA Guidance Concerning Demonstration of Comparability of Human Biological Products including Therapeutic Biotechnology-derived Products.
