BIODEVICE SYSTEMS
Cell based assay
We provide in vitro testing of material biocompatibility (specifical activity) for different kinds of biological and medical applications (including cytotoxycity analysis according to ISO).
Safety evaluation studies are conducted on a variety of biomaterials, medical devices, and related products to identify the presence of toxins or any other potentially harmful effects.
The final stages can include high-resolution scanning, computer recognition, reconstruction and 3-D structure simulation of biological tissues, image analysis and quantification of the tissue-engineering construction using computerized modelling and animal tests with hystological examination.
One of the main directions is evaluation of biological properties of the test materials before animal or clinical evaluations.
* Cell-based assays utilising 3-D culture technology reproduce more faithfully the cell behavior in vivo compared with 2-D cell cultures and, importantly, respond to drugs and other test materials in a manner more preductive of these agents' effects in animal models or clinical tests.
* Human primary cells used in tests are prepared from human tissues sourced with full ethical permission, and compliant with international regulations on the use of human tissues in preclinical research and development. All cells are supplied with quality control data confirming absence of HIV, HBV and HCV human viruses, and mycoplasma contamination, confirmed by PCR-based methodology and ELISA, respectively. Cell identity is confirmed by fluorescence-activated cell sorting (FACS), using multiple cell surface markers. Cells are typically supplied with a recommended protocol for cell recovery from the frozen state and with general information on cell performance in culture. Additionally, data may be supplied describing cell performance in a representative cell-based assay, e.g. for measuring test-sample cytotoxicity.
