The Biological Material Analysis Unit develops preclinical, cell-based test models for the biological evaluation of medical products.
The development of biocompatible and immunocompatible medical products, such as medical devices and drugs, requires consideration of the interaction between materials or active substances and biology (biomolecules, cells, and tissues) to be able to use them safely on and in humans.
The Biological Material Analysis Unit therefore pursues an interdisciplinary approach. At the interface of medical device or drug development and immunobiology, materials, substances and active agents are evaluated, as well as in cooperation optimized, or newly developed for industrial partners. Standardized diagnostic screening test procedures are also developed for this purpose.
The focus is on cell-based test scenarios, test systems and analytical procedures for in vitro use. The developed processes form the basic framework for the questions to be investigated. In the implementation, the focus is primarily on physiological processes, i.e., processes in the patient. With such in vitro tests in the preclinical phase, the most suitable materials / active substances for the respective application can be identified and evaluated quickly and reliably, thus accelerating the development of novel medical products. The test scenarios are based on suitable acceptance criteria for method development and validation.
The Fraunhofer IKTS group’s place of work is at the Fraunhofer Institute for Cell Therapy and Immunology IZI in Leipzig. There are close cooperations with groups at the Fraunhofer IZI with the aim to advance medical products and cell therapeutics for industrial applications.
In the preclinical testing of drugs, bioassays (Potency Assays) are indispensable to investigate the desired mechanism of action or to validate it in vitro.
Various scenarios were developed in the working group for this purpose:
Conventionally, materials are examined in vitro in cell culture plates, which makes quantitative comparisons between materials (test specimens), e.g., with different geometries, difficult.
The patented in vitro test system ClicKit-Well was developed for the reliable analysis of surfaces (DE 102018221415 B3). With its surface standardized areas (e.g., 96-well format) on material test specimens, it allows quantitative comparisons between materials.
Establishment of macrophage-based bioassays (Potency assays), screening and Mode of Action assays for service and transfer
Investigation of the influence of materials and agents on bone formation
Biological assessment of materials (in the context of research and development) analogous to DIN EN ISO 10993
Further competences of the Biological Material Analysis Unit: