“ClicKit-Well” Validated – Standardized Biomaterial Testing Ready for Practical Use

Biomaterials, used in implants for example, come into direct contact with living tissue and must not cause any harm. In order to ensure biocompatibility, these materials are tested in the laboratory prior to clinical use. Test specimens are produced from the biomaterial, placed in cell culture plates, added with biological material, and the reactions are measured. However, this conventional test environment is error-prone and there is no standardization. This was the starting point for the Biological Materials Analysis group at Fraunhofer IKTS: it has developed the “ClicKit-Well”, a testing system that produces standardized surfaces on test specimens, enabling quantitative comparison of materials. Following successful prototype development and in-house application, the VIP+ project UniBioface involved verification, validation and preparation for practical transfer.

Verification and validation

The verification phase involved testing of whether the manufactured “ClicKit-Well” met the defined specifications. Evaporation of cell culture media was tested, for example, and also fluid-tight sealing against test specimens. The results showed that the system meets all requirements: evaporation is comparable to that of standard commercial cell culture plates, and the system produces fluid-tight cell culture cavities on various materials as intended, from smooth to rough and from rigid to flexible. The subsequent validation phase aimed to confirm the suitability of the test system for eukaryotic cell studies. For this purpose, critical points of the key applications were first defined (Fig. 1), after which data was collected and then assessed. The assessment compared the “ClicKit-Well” results with those from conventional cell culture plates, focusing on accuracy and on intra-assay and inter-assay variability (Figs. 2 and 3). Since all tests met the specified criteria, the “ClicKit-Well” is now considered validated.

Transfer to practice

The transfer phase of the project highlights the system’s broad application potential. The “ClicKit-Well” addresses both testing laboratories and R&D environments, providing a standardized approach for the biological evaluation of materials and surfaces – a key step in the development of safe and functional medical products, implants and coatings. Contract negotiations with licensees are currently underway, marking the start of patent commercialization. The “ClicKit-Well” (Fig. 4) also remains an integral part of the group’s cell biology service portfolio.