Many of our clients develop pharmaceuticals that require cell-based immunoassays to measure an immune response. We can test sera for IgG or other antibody isotype responses. Furthermore, we offer services that can also determine whether cell activation is involved by using cell-based immunoassays like mixed lymphocyte reaction (MLR) or natural killer cell activation.
Many clients has also asked us to perform toxicity studies. We have a broad range of experience to tailor immunoassays and some of our past requests included whether cytotoxic T lymphocytes have been sensitized to a drug, whether the immune system cells have been activated by the detection of cytokines being released, or whether there is a presence of a specific cellular receptor to a compound.
Here are other areas of work requested from our clients:
- Efficacy, Potency, GMP Lot Release
- Safety – Inflammatory response, Inflammation
- Pharmacodynamics (PD), Biomarkers
- Mechanism of Action (MOA), Immunomodulation
- Host immune response, Neutralizing antibodies, Antidrug Antibodies (ADA)
Our Expertise in Cell Biology
Our expertise in cell biology enables us to develop, validate and perform cell-based assays from primary tissue, such as bone marrow, spleen, blood, as well as with culture cell lines.
These assays can be performed from “research level” or can also be developed using validation methods with GMP or GLP assays. We have a process in place for our clients, and once the assay is developed and validated, your preclinical or clinical samples can now be analyzed.
There is a menu of assays that can be used to select the appropriate assay for your specific use. Examples of uses would include:
- Targeting specific cells using antibodies or other moieties (as in cancer drug development)
- Determine whether drugs cause inflammation when administered to animals in PK studies or in people in their pre-clinical or clinical studies
- Cell-based assays used for drugs that are designed to modulate the immune system or to detect host antibodies against a drug that neutralize its activity.