GMP Process Development


Preclinical development of specific T regulatory cell therapy to treat immune related diseases (Specific T-REG Therapy – STREG)

Project in cooperation with Main Department of GMP Cell and Gene Therapy

Preclinical development of an advanced therapy medicinal product (ATMP, Palintra®) for the prevention of graft versus host disease (GvHD)

Preclinical development of an advanced therapy medicinal product (ATMP, Palintra®)
© Fraunhofer IZI

The main complication that occurs following hematopoietic stem cell transplantation is graft-versus-host disease (GvHD). The immune response demonstrated by the transplant to the host can prove fatal or result in serious long-term damage and a lifelong need for treatment. Clinical symptoms include inflammation that usually affects the skin, intestine and liver. There is an over 30 percent chance that acute GvHD (grades II to IV) will emerge following stem cell transplantation; this figure rises to 40 percent for chronic GvHD. In terms of pathophysiology, GvHD is triggered by the donor’s immunocompetent T cells. These cells recognize antigens from the recipient, which leads to the activation, expansion and release of pro-inflammatory factors besides the activation of additional inflammatory cascades, causing tissue damage in the affected areas.

Current immunosuppression strategies for treating and / or preventing GvHD often prove inadequate, making it all the more necessary for new treatment options for GvHD to be developed as soon as possible.

The GMP Process Development Unit is working on protocols and procedures in preparation for manufacturing an ATMP (advanced therapy medicinal product) to help prevent GvHD under GMP conditions.

Development of AI-driven ATMP production facility for hospitals

Cell and gene therapeutics, so-called advanced therapy medicinal products (ATMPs), have a very high therapeutic potential. In hematology and oncology CAR-T cell therapy has been used in Germany, for example, since 2018. However, complex logistics processes from centralized production sites and inflexible manufacturing and application schemes make the production of these cell therapeutics very time and cost intensive. In the EU project "AIDPATH" (Artificial Intelligence-driven, Decentralized Production for Advanced Therapies in the Hospital), project partners from industry and research are now working on the development of an automated and intelligent facility capable of producing targeted and patient-specific cell therapy directly at the point of treatment, i.e. in the hospital. In addition, the project addresses the integration of the facility into the hospital environment, taking into account logistics processes as well as data management and data security.

Fraunhofer IZI is contributing its expertise to the project, particularly in the automation of manufacturing processes and plant networking. The main site in Leipzig has long been a central manufacturing and development site for a CAR-T cell therapeutic used to treat certain forms of blood cancer.

The "AIDPATH" project, which started in January 2021, is funded for four years under the European Union's Horizon 2020 framework program for research and innovation under grant number 101016909.

AIDPATH project consortium

Fraunhofer Institute for Production Technology IPT, Aachen, Germany (Coordination)

Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany

Panaxea BV, Amsterdam, The Netherlands,

Foundation for Research and Technology - Hellas, (FORTH), Patras, Greece

IRIS Technology Solutions, Sociedad Limitada, Madrid, Spain

Red Alert Labs, Maisons-Alfort, France

Fujifilm Irvine Scientific Inc, Tilburg, The Netherlands

Hitachi Chemical Advanced Therapeutics Solutions, Allendale, USA

AglarisCell SL, Tres Cantos, Spain

Würzburg University Hospital, Würzburg, Germany

Ortec Optimization Technology B.V., Zoetermeer, The Netherlands

Fundacio Clinic per a la recerca Biomedica, Barcelona, Spain

SZTAKI Institute for Computer Science and Control, Budapest, Hungary

University College London, London, Great Britain