CLS Cell Lines Service GmbH specializes in the preservation and quality control of immortal and primary cell lines and the production of products from these cell lines. In its subproject, the SME is dedicated to the provision of cell materials and the development of assays for the detection of contaminations such as mycoplasmas, the analysis of the interactions between cell culture medium and therapeutic cells and the cultivation of different cell types on the basis of the supplementation of cell culture media with hPL as replacement for animal serum (FBS-fetal calf serum) and with chemically defined additives.

The Fraunhofer-Institute for Marine Biotechnology and Cell Technology (EMB) develops new technologies, processes and equipment in the fields of cell isolation, handling and analysis. The innovative cell technologies are used in diagnostics, medicine and cosmetics. The focus of the subproject is the automated microscopic monitoring of cell culture with regard to cell movement, cell division and cell size as well as the analysis of growth curves.

The Fraunhofer-Institute for Manufacturing Engineering and Automation (IPA) specializes in the development and realization of automation solutions in the fields of cell and tissue production, drug screening, diagnostic laboratory procedures and bioprocess and pharmaceutical technology. The institute takes over the scientific-technical project lead and will evaluate existing technologies for quality control and will realize the modularization/automation of suitable methods as well as the adaptation to high throughput.

The Fraunhofer-Institute for Silicon Technology (ISIT) specializes in microsystems technology and chip-based biosensor technology, e.g. for use in the field of health. In the project, the research institute is responsible for the detection of bacterial contamination via surface antigens using a biochip platform and the development of inline measurement technology on silicon chips.

IBA GmbH is an innovative biotechnology company and has been marketing its products worldwide for more than 20 years. Within this joint project, IBA focuses on the new, technologically unique cell isolation technology Fab-TACS (Fab-based traceless affinity cell selection). IBA's goal in this context is to use this technology to create the basis for new standards with regard to the quality of cell products. The almost complete detachability of the isolation reagents under gentle conditions (by adding vitamin H) makes it possible to isolate cells by positive selection without negatively affecting cell functionality. This distinguishes Fab-TACS technology from all other technologies and products on the market. Making this characteristic an important cornerstone for the future regulatory definition of the QC of cell products is a central concern of the IBA and thus also the focus of the IBA contributions in this consortium.

The SME Ibidi GmbH is a leading provider of functional cell-based assays and products for cell microscopy. Within the project, Ibidi will characterize and evaluate the fitness and activity of cells living cells using video microscopy.

Innovent e.V. Technology development Jena is a non-profit, industry-oriented research institution focusing on product and method development in the fields of surface technology, primer and chemical surface treatment, biomaterials, magnetic and optical systems, and analytics. Within the framework of the project, the research institute in cooperation with Labor Dr. Heidrich will focus on the monitoring of biocompatibility, in particular the genotoxicity of biomaterials in tissue engineered products.

Labor Dr. Heidrich & Kollegen GmbH is an independent, owner-managed regional laboratory which, in addition to the broad spectrum of laboratory medicine, has focused on haemostaseology, autoimmune diagnostics, transfusion medicine and molecular diagnostics. This involves, among other things, the development of new methods for molecular diagnostics, the discovery and research of biomarkers or the use of genetic findings for public health. Within the project, the laboratory will evaluate the performance of the Next Generation Sequencing (NGS) technology for the detection of genotoxicity of reagents and materials in collaboration with Innovent and for the detection of bacteria in comparison to conventional detection methods. Furthermore, a multiplex ELISA assay for the determination of the differentiation state of therapeutic cells will be developed.

EurA AG is the coordinator of the joint project. EurA AG is in charge of research and development projects in medicine and cell therapy and is a network management institution for the ZIM-funded innovation networks "Quality Control of Medical Cell Therapy" and "Alternative Method to Animal Testing".

More Information: www.Qualitaetskontrolle-zelltherapie.de; https://www.alternativen-zum-tierversuch.de/