Bioactivity and Cellular Assays
Adequate bioassays are needed during all stages of drug development, e.g. for candidate screening, characterization of potential modes of action and safety assessment during preclinical testing as well as potency, stability and comparability testing during manufacturing.
Glycotope provides extensive knowledge in the development of functional assays for different biotherapeutics. We have specialized experience with complex cell-based assays for antibodies using human primary immune cells to support drug development in the field of immuno-oncology, e.g. immune-cell recruiting bi-specifics and checkpoint antibodies. Furthermore, we also have long-term expertise in developing in vitro bioactivity test systems for hormones and coagulation factors.
We develop multiple types of bioassays by using a broad array of technologies, e.g. cell-based assays, multicolor flow cytometry, imaging, ELISA, immunohistochemistry, immunofluorescence, Alpha technology and electrochemiluminescence (ECL).
With our broad experience we establish the best assay design to meet individual customer requirements for a specific drug from assay design up to method development and ICH-compliant validation.
Our Core Competencies
- Target binding
- Fc receptor binding
- Blood cell binding
Cell viability and cytotoxicity
- ADCC with different effector cells
- Proliferation assays (2D or 3D culture)
- Apoptosis detection
- Cell cycle analyses
- Isolation and phenotyping of immune cell populations
- T cell activation
- T cell proliferation
- Immune checkpoint assays (e.g. Mixed lymphocyte reactions)
- Receptor modulation & phosphorylation
- cAMP release assay
Cytokine release testing
- Whole blood assays
- PBMC-HUVEC co-culture assay
- PBMC high/low density pre-culture
- Coagulation assays for blood factors
- Enzymatic activity assays (e.g. Enzyme replacement therapy)