Here is the very recently issued FINAL FDA guidance document on CAR-T cell product development! When the DRAFT guidance was issued two years ago xCellarate was conducting a GMP compliance assessment of a CAR-T manufacturing site. In the 2-years since, there have been advancements on some fronts (ie. potency assay definitions) and ongoing questions/challenges on other fronts (division of/mixing of, performance verification standards in a healthcare setting vs a traditional pharma manufacturing environment). Exciting times! #cellandgenetherapy #gmp #cmc #qualitymanagement #regulatoryaffairs
