Marin Biologic Laboratories - GLP and GMP Compliant Assay Development , Validation and Testing Services

Marin Biologic Laboratories is a contract research organization (CRO) that provides custom research and development as well as GLP and GMP compliant assay development, validation and testing services for the pharmaceutical, biotechnology, diagnostic and agricultural industries.

We blend the fields of cell biology immunology, molecular biology and biochemistry to tackle complex projects in an innovative and timely manner. However, our in-depth expertise in each individual field allows for a more focused approach to complement your team of scientists. What distinguishes Marin Biologic from other contract laboratories is this breadth of scientific knowledge, our client communication and our flexibility.

Cell-based assay and 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.

Protein expression

Using mammalian or insect cell cultures, our scientists can manufacture proteins on 100g level. Our staff can provide cell pellets, conditioned media or membrane preparations. With our experience in classical protein purification, we can optimize your protein expression and production. Our scientists are very experienced in transfection and stable cell line generation.

Elisa tests for cell based assays

Frequently, we are asked to develop an ELISA test to quantify specific proteins or small molecules (metabolites) for a cell-based assay. We will work with you to develop or to in-source a commercially available ELISA test or other immunoassays that will quantitatively detect your molecule.

Our scientists will consult with you and discuss the most efficient strategies that can be employed. Should you need specific monoclonal antibodies to use in your ELISA test, we can generate the hybridomas and produce monoclonal antibodies at up to 1g / week.

Enzyme assays

Enzyme assays have been used to monitor protein purification and production. If your pharmaceutical is an enzyme inhibitor, we have used enzyme assays to characterize drug potency and measure drug concentration. Some of the enzyme assays we have developed are used for drug stability as well as lot release.

Protein production, purification and analysis

Our scientists will consult with you on optimizing protein production, protein purification and analytical analysis. If your protein is generated via recombinant methods, we will employ the appropriate affinity methods of purification.

Should you wish a homogeneously purified protein, we will discuss the strategies with you prior to final purification. Of course, if you have a protein purification strategy, we will gladly employ your purification scheme.

With many of the protein purification protocols, we will develop a purification scheme to monitor increase in yields and specific activity. Should you not have a method to quantitate protein activity, our scientists will consult with you about assay development.