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Hello forum,
I'm in the middle of some research into tissue donor screening requirements for blood-borne pathogen testing. We want to make sure that our clinical screening process is up-to-date with the most current regs and also make sure that it covers the requirements for all of the countries into which we may expand our operations. Our starting material is a muscle tissue biopsy which is then more-than-minimally manipulated to create our cell product.
The regulations are fairly straightforward for some of the countries I've reviewed, but I'm hoping to get some clarification if anyone out there has special expertise in this subject. I'm specifically looking for any appropriate tissue-donor screening and/or BBP regulations for United States, Canada, EU and Japan.
Thanks in advance!