Cell & Gene Comparability: FDA's Recommendations for Coping with Change
Discussions of comparability in the cell and gene industry have historically centered around two big questions: Will this change have a minor, moderate, or major impact on the quality of our product? And: What information will we need to provide to demonstrate that our pre- and post-change products are highly similar?
The answers to the related questions will depend on how our individual products react to what we do to them and when we make the changes.
However, some helpful high-level reminders and/or clarifications received, several of which have summarized in below link.
ارسال به دوستان