I was reviewing material for a document on the Quality Round GAiT is managing. I thought the following directly relevant so I reiterate here:
It is really important to engage your Regulator at the first possible juncture: many think that if they start with research materials can they be used for subsequent GMP work due to the rederivation of H9 ESCs from ‘research-grade’ to ‘clinical-grade’ and ‘clinical-grade H9 ESCs’ being in clinical trials.
That may not so easily be applied to iPSCs Tenneille Ludwig has learned, as they can be considered more highly manipulated and ESCs are minimally manipulated. The rules for iPSCs may be different and what the community can do with ESCs may not so easily
This may be a problem for you, it may not, only your Regulator will know for sure.
Additionally talking to Regulator early is #1 recommendation from the UK Regenerative Medicine Platform Pluripotent Stem Platform Workshop meeting in 2016.
