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Currently in Phase 2 of a biologic, and in the process of transitioning to a new service provider to conduct one of the IP batch release tests, due to timing constraints. The testing technique is very similar. We are considering how this change should be submitted to the FDA as an IND amendment, allowing time for their review and response before implementation, as the clinical trial is ongoing. We also seek clarity on whether this change constitutes a substantial modification, as outlined in European guidelines. What do you think should be considered in terms of comparability exercise? Thanks in advance.