When you are at the cutting edge of science, there often is no validated assay to repeatedly prove your results for drug product or for clinical results. At that point, a team that is focused on efficiently developing an assay that is perfect for your ongoing needs makes sense. Having developed hundreds of customized assays over the course of 3 decades, the creative team at Marin Biologic can bring your results to an entirely new level, quickly and cost-effectively. Contact me link here.
We employ both the scientific approach and the “art” of cell culture to your projects. We can recommend strategies and provide contract services for cell-based assays, tissue culture, cell culture optimization, bioassays including stem cells and protein expression systems for large-scale tissue culture (including hollow fiber). Our laboratory is GLP and GMP compliant for projects destined for FDA submission, allowing your custom assay development to be brought through pre-clinical assay validation to clinical drug development. Learn about our Process here.
Cell-Based Assay, Bioassay Development
Cell-based assay or bioassay development can range from cytotoxic assays including apoptosis to cell proliferation and metabolic assays. Cell-based assay development can also include high throughput screening assays and other custom bioassays used to characterize drug stability for GLP GMP lot release, drug potency and for drug purification and production support. Mechanisms of action, such as receptor binding, receptor activation, cell signaling, drug internalization and subcellular localization can be delineated in cell-based assays following treatment with your pharmaceuticals. Bioassay development can encompass testing of conditioned medium, cell lysates or whole cells in a variety of formats including ELISA and immunohistochemical methods. Our scientists can grow and differentiate stem cells as well as provide assay development to monitor stem cell differentiation using specific gene expression.
Custom Cell Culture
Custom cell culture can be performed for your cells, whether it is primary explants, cloning and optimizing expression of a cell line or developing the optimum medium, to include serum-free medium. Large scale cell cultures using bioreactors can be implemented for production of your specific protein. Additionally purification of your protein can be performed from either the cells themselves (eg. baculovirus) or from the conditioned media (see Biochemistry).
Using mammalian or insect cell cultures, our scientists can manufacture proteins on a 100 gram level. Our staff can provide cell pellets, conditioned media or membrane preparations. With our experience in classical protein purification (see Biochemistry) we can optimize your protein expression and production. Our scientists are very experienced in transfection and stable cell line generation.
These assays can be performed as “research level” assays or can be developed and validated as GMP or GLP assays. Once the assay is developed and validated, then your preclinical or clinical samples can be analyzed.
- 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)