As our company matures and we continue to execute to our mission of accelerating Regenerative Medicine, we find ourselves increasingly involved in conversations around scalable cGMP cell manufacturing, qualification of cell and cell-based therapies, and regulations around clinical translation of hMSCs and hMSC-based therapeutics. While the US FDA and other global regulatory agencies provide guidances on the regulations surrounding clinical translation of cellular products, it is evident that there is still great uncertainty around rules, regulations, processes, timelines and costs associated with clinical translation.
How do you move from pre-clinical to clinical studies?
How must you manufacture your cells?
What data do you need to present to the FDA to move to clinical trials?
What sort of characterization assays are needed?
What is the process for engaging the FDA and moving to clinical trials?
When do I need to do all of this?!
These are just a few of the questions that we commonly hear from our customers. In an effort to facilitate our customers’ path to the clinic, we will be publishing here a series of blog posts on clinical translation of hMSCs. These posts are meant to point you to the relevant guidances and points to consider surrounding clinical translation of hMSCs and are not meant to be the definitive authority on these matters. We recommend that you engage your Quality and Regulatory teams (and/or consultants) early on in your Process Development efforts to ensure that you are considering all regulations and guidelines in developing a scalable, clinically- and commercially-relevant process and product.
What other questions do you have around clinical translation of hMSCs and hMSC-based therapies?
Check back in next week for our first blog post in this series.