News and press releases

Audit confirms RIBOLUTION Biomarker Center at Fraunhofer IZI the successful implementation of software development processes for medical devices software (according to IEC 62304 and ISO 14971).

For the development and behavior of cells, their biomechanical environment is as important as biochemical signaling molecules. In the body, biomechanical stimuli are exerted in particular by the extracellular matrix, which provides shape to tissues and surrounds many cell types.

With the aim of faster, safer and more cost-effective manufacturing of advanced therapy medicinal products (ATMPs), the Department GMP Cell and Gene Therapy of the Fraunhofer Institute for Cell Therapy and Immunology IZI implements a digital Manufacturing Execution System provided by Lonza.

Together with colleagues from Monash University (Melbourne, Australia) and other institutions, Fraunhofer IZI researchers have elucidated the helical ultrastructure of the metalloprotease Meprin alpha. The results have now been published in the journal Nature Communications.

Cell-based immunotherapies, such as CAR T cell therapy, are effective means of treating cancer. However, technological advances in various disciplines are needed to meet the rapidly growing demand for such novel drugs. Researchers from the Fraunhofer Institute for Cell Therapy and Immunology now summarize the current state of research and discuss possible solutions to overcome biological and technical hurdles in their recent article "Potential solutions for manufacture of CAR T cells in cancer immunotherapy" published in the journal Nature Communications.

The EU-funded project REMEDi4ALL willl make a major leap forward in drug repurposing, or finding new therapeutic option for existing drugs, in areas where there are high unmet medical needs. The 3 Fraunhofer institutes participating, for Translational Medicine and Pharmacology ITMP, for Cell Therapy and Immunology IZI and for Algorithms and Scientific Computing SCAI, combine expertise in the realization of in-silico and in-vitro driven drug repurposing programs, the design of predictive in vivo models, the execution of clinical trials and algorithm development for the analysis of drug discovery data.

The Fraunhofer Institute for Cell Therapy and Immunology IZI is certified as a GLP test facility. Most recently, the institute conducted, among other things, a preclinical study to test the safety of an ATMP for the treatment of cartilage damage to the knee. An advanced therapy medicinal product (ATMP) developed by BioPlanta GmbH was subjected to extensive testing under GLP conditions with regard to its potential undesirable biodistribution and tumorigenicity.

Coordinated by the Fraunhofer Institute for Cell Therapy and Immunology IZI, seven Fraunhofer institutes are working on the development of automated production technologies for mRNA-based drugs. RNAuto is a Fraunhofer lighthouse project that will receive €8 million in funding from the Fraunhofer-Gesellschaft over the next four years.

The Fraunhofer Institute for Cell Therapy and Immunology IZI and BioNTech have signed a framework agreement in April 2022.

At the Fraunhofer Center for Microelectronic and Optical Systems for Biomedicine (MEOS) in Erfurt, the MEOS Innovation Center for Precision Analysis of Cell Therapy Products, or MIC-PreCell for short, is being established until summer 2023. Funded with 750,000 euros from the Free State of Thuringia, this center will then support the development of new analysis methods for quality assurance and process control for the manufacturing of cell-based therapeutic products.