Cell-based assays or bioassays are recommended for cell behavior and/or cytotoxicity testing to:
- Evaluate the biological activity of a medical device/biomaterial surface
- Evaluate mechanical and mechanobiological interactions
- Achieve proof of principle studies at early-stage development including discovery, pre-clinical and clinical.
Cell behavior and/or cytotoxicity testing ensures medical device biomaterial biocompatibility and is required for all implants that come into contact with human tissue. Cell-based assays of medical device surfaces are integral to and essential for the FDA drug approval process and commercialization.
CMDC Labs’ Bioassay Expertise
The CMDC Labs team has extensive bioassay expertise including with:
- Primary cells or secondary immortalized/transformed cell lines
- Commercially accessible immortalized/transformed cell lines (clonal cell lines)
- Customer-designed transfected cell lines (clones/sub-clones) to meet project requirements
According to clients’ needs, whether an established cell-based assay is transferred to CMDC Labs or a custom-designed bioassay is necessary, our bioassay expertise accumulated over 20 years of experience enables highly efficient, rapid and cost-effective routes for successful development, qualification and/or validation of the cell-based assays that you need. CMDC Labs also performs cytotoxicity for FDA 510(k) approvals.
We are experts in the art and science of cell culture and biomedical technologies. Scroll down for more information on some of the different assays CMDC Labs has successfully designed and implemented for its clients.
Cell-Based Assays for in vitro Interactions with Drugs/Biologics
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 biotechnology testing laboratory 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.
CMDC Labs’ Bioassay Services for in vitro Live Cell Interactions with Medical Device/Biomaterial Surfaces and/or Drugs/Biologics
Some of the many assays our biotechnology testing laboratory performs include:
- Medical device and biomaterial surface cellular and biological activity bioassays
- Medical device coating and biomaterial coating surface cellular and biological activity bioassays
- Biological activity and potency cell bioassays
- Comparability, lot-release and stability bioassays
- Clinical sample analysis/studies, pre-clinical sample analysis/studies, sample testing and analyses
- ADCC, antibody-dependent cellular cytotoxicity bioassays
- CDC, complement-dependent cytotoxicity bioassays
- CMC, complement-mediated cytotoxicity bioassays
- CTL, cytotoxic T lymphocyte killing bioassays
- ADA, anti-drug antibody, drug tolerance/drug inhibition bioassays
- Flow cytometry-based reporter and gene/protein expression bioassays
- Flow cytometry-based singleplexed and multiplexed high-throughput cytokine bioassays assays
- MLR, mixed lymphocyte reaction bioassays
- Cell enzyme binding or activity, metabolic bioassays
- Cell phenotyping bioassays
- Cell proliferation bioassays
- Cell surface or intracellular signaling bioassays
- Cell toxicity, apoptosis, and necrosis bioassays
- Cell transfection, transcription and protein expression bioassays
- Agonist and antagonist bioassays
- Drug combination/multi-drug bioassays
- Drug delivery bioassays
- Drug elution bioassays
- Drug metabolic breakdown bioassays
- Drug subcellular fractionation and localization bioassays
- Drug target pathway and phosphorylation bioassays
- Gene activation and expression modification bioassays
- Hematocompatibility bioassays
- Mechanics of action bioassays
- Mechanism of action bioassays
- Receptor, protein binding, and turnover bioassays
- Reporter bioassays
- Exosome bioassays
- Metabolic bioassays
- Migration and wound healing bioassays
- Morphological cell analysis
