The immune response to a medical device/biomaterial surface or drug is highly complex and relies on several different types of cells including dendritic cells, macrophage cells, T cells and B cells. Success or failure of the medical device/biomaterial surface or drug depends on the actions of those cells and can be assessed using an array of cell-based assays and immunoassays.
CMDC Labs’ multidisciplinary knowledge of immunology, cell biology, medical device, coatings and drug investigations provides a comprehensive platform for evaluating immunological response. Various single- and multi-cellular assays are used by our biotechnology testing laboratory to help clients understand their medical device/biomaterial surface or drug as well as to satisfy requests from the FDA.
CMDC Labs’ Capabilities
A number of cell-based assays using various detection platforms are performed by CMDC Labs during discovery, development and pre-clinical/clinical studies to obtain rapid, high-quality, reproducible data. Cell-based assays/immunoassays and detections platforms listed include:
Immune Functional Cell-Based Assays/Immunoassays
- T Cell assays
- B Cell assays
- Dendritic Cell (DC) assays
- Macrophage assays
- Monocyte assays
- Platelet assays
- Neutrophil assays
- Innate Lymphoid Cell (ILC) assays
- Co-Culture of Epithelial/Immunological/Microbiological Cell assays
- Haematopoietic Stem Cell assays
- Microglial/Neuronal Cell assays
- Tumor/Immune Cell assays
- Fibroblast assays
- Cytotoxicity assays
- Antibody-Dependent Cellular Cytotoxicity (ADCC) assays
- Complement-Dependent Cytotoxicity or Complement Mediated Cytotoxicity (CDC or CMC) assays
- Cytotoxic T-Lymphocyte (CTL) killing bioassays
- Proliferation and Surface Marker Differentiation assays
- Mixed Lymphocyte Reaction (MLR) assays
- Neutralizing Antibody assays
- Anti-Drug Antibody (ADA), Drug Inhibition Activity assays
- Macrophage, Monocyte and Granulocyte Activation assays
- Oxidative Stress and Nitrosative Stress assays
- Custom Designed assays
Detection Platforms
- Flow Cytometry
- Cytokine and Chemokine Analysis
- Microscopy and Imaging
- Gene Expression Analysis
CMDC Labs’ Experience with Standardized & Customized Immune Functional Cell-Based Assays and Immunoassays
CMDC Labs’ team provides clients with standard or custom immune functional cell-based assays and immunoassays. Immunoassays are often customized for our clients in many different formats. Our scientists have over 20 years of experience developing and performing medical device and drug-model immunological cell-based assays and immunoassays in order to meet our clients’ budgets, timelines and communications requirements.
CMDC Labs’ analytical support enables clients not only to select which assays are best suited to their needs but also to transfer their assay for further development and validation in house. Our lab utilizes rigorous procedures to generate accurate, high-quality and reproducible data in a reasonable timeframe and budget. Immune functional cell-based assays and immunoassays that require GMP/GLP/ICH regulation can also be imposed by CMDC Labs through further development and/or validation when performing your assays and analyses.
