iPSc-derived products: Current regulations

Abstract

Developing clinical grade PSC-based cells for use in patients requires not only careful attention to cGMPs (current good manufacturing practices) but also careful consideration of a variety of issues that include accessing tissue in an ethically appropriate fashion and adhering to the current rules and regulations for specifi c local, national, and international jurisdictions, which, if not harmonized, will likely hinder progress. Countries have developed different ways to accelerate translation, and in this article, we discuss the issues specifi c to iPSC-based manufacture and how these issues are being resolved.