Cell-based assays or bioassays measure the response of cells to drugs or degradation components released from drug-eluting coatings to establish their biological relevance and physiological importance. Bioassays, such as cytotoxicity evaluation, are invaluable tools for screening elution components prior to performing more complicated studies and are frequently utilized as quality control measures for monitoring the release of raw and manufactured materials. CMDC Labs’ contract service professionals are experts in developing customized, project-specific and standardized bioassays as well as in the quantitative and qualitative analysis of cultured and primary cellular interaction with medical device biomaterials or drugs (e.g., small molecules, biologics). Our Ph.D. scientists have successfully interfaced with the FDA on behalf of our clients upon request.
Additionally, CMDC Labs specializes in in vitro cell-based assay testing services for clinical and pre-clinical studies (including method development, qualification, validation, transfer and potency testing) according to guidelines from both the FDA and the International Council for Harmonization (ICH). CMDC Labs has extensive experience with cells and cell banks at both non-GMP/GLP and GMP/GLP levels that encompass a number of different mammalian cell types and clones as well as custom-designed cells, clones or sub-clones. Our multidisciplinary expertise has enabled us to produce over 150 different bioassays for our clients during the past 20 years.