Cell Engineering and Characterization
Cell based assays are an important aspect of biomedical research and drug development. Cell based assays are used to identify and screen drugs, understand mechanism of action, characterize their quality attributes, and evaluate toxicological risks. Cell based assays are used from the beginning to the end of a drug development lifecycle.
In the early phases of drug development, one may engineer cells to express the protein of interest or as a screening tool to study a biochemical signaling pathway. This phase may require advanced cellular engineering. Genes are engineered, cells transfected or infected with viral vector and the cells are selected for desired attributes. Often expression tags such as GFP or Luciferase are used to identify the best clones. Cells may be studied using Fluorescence microscopy, flow cytometry, or plate based optical measures. Functional tests may include cell proliferation assays, cell death assays, reporter gene assays, and cell signaling assays. BioTether Sciences operates an advanced cell engineering lab and excels at characterizing cells and proteins. Our fluorescence imaging produces stunning pictures and data showing cellular morphology, transfection efficiency, and viability. We use the Thermo Evos Fluorescence microscopy cell imaging system. Our Molecular Devices and MesoScale Discovery microplate readers measure fluorescence, luminescence, UV/Vis, and electrochemiluminescence, powerful tools to enable researchers to advance protein and cell biology programs. More advanced biopharmaceutical programs may need cell based assays for characterization and GMP lot release. Potency assays are a mainstay in a drug development program. Often the most desirable and informative test, is a cell based assay to measure the dose-response of the drug. We can develop and validate cell based assays to measure potency, often expressed as the concentration that stimulates a response (EC50). Reporter assays or ELISA are used to measure the dose response because they provide a robust and sensitive read-out of the functional interaction between drug and living cell.
Once in clinical studies, regulators want the sponsor to study the immunogenicity profile of the biopharmaceutical. This includes immunogenicity studies to determine if antibodies produced by the patient are neutralizing the drug product. Cell based assays are useful to study this phenomenon because they capture the complexity of a living system. Cells can recapitulate the drug mechanism of action and how anti-drug antibodies may interfere with cellular processes.
BioTether Sciences staff has decades of drug development experience and wants to share our bioanalysis expertise to enable your success.