The GMP Process Development Unit is responsible for transferring manufacturing processes from the lab into a clinical setting. In order to obtain official manufacturing licenses for the production of clinical test samples, either GMP-compliant processes are developed from scratch or existing processes adapted and optimized.
The department focuses primarily on cell- and gene-based drugs, known as Advanced Therapy Medicinal Products (ATMPs). These include antigen-specific T cells, CAR-T cells, CAR-NK cells, dendritic cells, mesenchymal stem cells (MSC), induced pluripotent stem cells (iPS) and tissue engineering products.
The development of GMP-compliant manufacturing protocols is closely associated here with the definition of respective quality controls.
In the development unit, process adjustments can be tested and optimized flexibly and cost-efficiently. The impact of new devices, media, seed densities and freezing protocols on the GMP process is also investigated here.
This then enables new processes to be implemented and validated in the institute’s GMP clean rooms.