GMP Manufacturing & Solutions
GMP, or Good Manufacturing Practices, are a set of regulations applicable to the manufacturing of health product candidates, especially medicines intended for human use, such as UCART product candidates. A company is required to comply with GMP regulations in order to be granted a license from governmental regulatory agencies to manufacture pharmaceutical product candidates. The Manufacturing department takes manufacturing processes established at the R&D level, converts them to GMP, and ensures their deployment with GMP compliant raw materials and environments. The department is responsible for the manufacturing of clinical trial material (“CTM”), making it available for clinical studies, and also for the manufacturing of final GMP commercial cellular gene therapy products. The team interacts internally with different departments ranging from development and planning, to regulatory and legal, as well as externally with raw materials contractors or GMP manufacturing contract organizations, Lonza and MolMed.