Department of GMP Process Development / ATMP Design

The Department of GMP Process Development / ATMP Design 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.

Furthermore, upstream and downstream processes are being developed for biomolecules in single-use reactors with a volume of up to 200 liters.

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.

GMP Biopharmaceuticals

In recent years, the increasing number of therapeutic monoclonal antibody (mAb) candidates under preclinical and clinical development have required new flexible, efficient, and economic opportunities for GMP production of therapeutic antibody candidates.

Newsflash / 21.5.2021

Simplified method developed for monitoring CAR T-cell therapies using flow cytometry

Researchers at the University of Leipzig, in cooperation with the Fraunhofer Institute for Cell Therapy and Immunology IZI and Beckman Coulter Life Sciences GmbH, have established a flow cytometry method that simplifies the analysis of CAR-T cells from patients' blood.

Press information / 1.2.2021

Optimization of novel immune cell therapies

The GMP Process Development Department collaborates with Klinikum Chemnitz gGmbH (Chemnitz hospital). Department head PD Dr. Stephan Fricke, as specialist in internal medicine, hematology and oncology and as senior physician at the Clinic for Internal Medicine III at Chemnitz hospital, builds the bridge to application.

Projects

Here we show you a selection of current projects.

 

employees working on a bench in clean room and laboratory
© Fraunhofer IZI