I have drawn GAiT members attention to this posting, Lygia. In the meantime, some points to consider:
1. The key initial lesson from people who have already started is make sure your donor consent is in order before you spend any money on resources. Many attempts to generate clinically useful material fail because the donor consent is not in order. GAiT will place an example of Donor Information and a Donor Consent Form during October/November 2018.
2. I would also HLA-haplotype the donor to the highest resolution possible. If you have a very useful haplotype with high resolution, you really know what you have. If HLA-haplotype analysis is low resolution, it might potentially match a larger % of a population, so it might look better from a marketing perspective but critics will quickly come after you to do higher resolution analysis. FujifilmCD, Lonza and others have made the most clinical-grade iPSC lines so far so I would look carefully at what they have done.
3. Early engagement with your local Regulators on what you are planning is also a very smart move to avoid disappointment and waste later on. Whatever you do, it must be acceptable to your regulatory agency, otherwise you will not get far.
4. It is important to realise that generating clinical-grade or GMP lines is expensive and your whole process will be judged on its weakest link. So, for example, if just one starting material (i.e. a growth factor in the medium) is research grade as apposed to clinical grade, then the whole process is research grade and your lines will need to be rederived (in a regulatory sense). Or if you don’t use suitably accredited GMP facility or personnel. Thus it is a good idea to ‘measure twice, and cut once’ as the English expression goes.
5. Participating in the GAiT Quality Round is also a smart move. Express interest (if you have not done so already) at https://www.surveymonkey.co.uk/r/8HQBXNQ
