Due to the specific nature of the material used for cell therapy, it falls within the regulations not only U.S. FDA current Good Tissue Practices (cGTP), 21 CFR 1271, but also under regulations for pharmaceutical or biologic products: 21 CFR 210 or 21 CFR 211.
The regulatory approach used for specific autologous cell therapies is dictated by their planned clinical use, method of clinical delivery and manufacture.
In this workshop, we will review try to translate translating these understanding into practice.