GMP Process Development

Projects

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.