MARIN BIOLOGIC LABORATORIES, INC.
Pre-clinical Contract Laboratory Services
Research, Assay Development, Validation and Testing Services
Contract Research Organization - CRO - GLP GMP Compliant

REGULATORY
GLP, GMP Compliant CRO

Assay Development Assay Validation GLP, GMP

Assays - GLP, GMP
Assay Development - GLP, GMP

Biological potency of a drug requires quantitation of a biological response that may involve cell proliferation or cell death (apoptosis), cell metabolism or intracellular signaling (receptor activation), receptor binding or gene reporter assays. These GLP and GMP assays have been used at Marin Biologic for drug release, stability and potency investigations submitted to regulatory agencies.

Cytokines, growth factors, hormones and other proteins can be specifically assayed by ELISA (enzyme linked immunoassay), by Cell Biology responses of cell proliferation, growth inhibition, cell signaling or other cellular responses including synthesis of specific metabolites (proteins), or by receptor binding assays.

We develop and perform sensitive and precise ELISA and RIA methods, affinity (Kd), Western blots and cell surface flow cytometry assays.

The scientists at Marin Biologic can develop and perform enzyme activity assays, substrate and inhibitor kinetics, specificity, pH and temperature dependence. Colorimetric, fluorescent and radiometric formats are used.

Stability-indicating assays have the sensitivity to detect changes upon degradation of the analyte. Such assays should be correlated with other analytical methods that indicate deviations in manufacture that occur upon purification or storage. Examples are loss of bioactivity correlated with cleavage (proteolytic degradation), oxidation, aggregation or polymerization of a protein.

Products are tested for compatibility with equipment, containers, syringes, etc. for retention of the proper form and concentration of the product. Products are also tested for no adverse effects on blood or other biological substrates.

Total protein concentration is estimated by absorption at 280 nm with corrections for nucleic acid contamination or at 205nm. A colorimetric method such as the Bradford biochemical staining method can be used. It is sensitive and specific for peptide bonds. Purified RNA or DNA is quantitated by UV absorption and can be visualized by staining on gels.

Affinity, ion exchange, size exclusion, hydrophobic and reverse phase or molecular sizing HPLC, liquid or gel chromatography methods are available

Marin Biologic Laboratories validates its assays according to USP, FDA or ICH guidelines. Validation reports are prepared. Work is performed under GLP (Good Laboratory Practices) conditions or GMP (Good Manufacturing Practices) conditions.

Marin Biologic scientists will work with your organization to design and implement the appropriate assays from conception through development. They will determine the specifications for assay validation, and upon completion of the validation study, will work with your regulatory personnel and statisticians to develop the final study report. Some of the reports generated are listed below.

Data Summaries
Validated Study Reports
Method and Result Reports
Assay Validation Reports
SOPs (Standard Operating Procedures) and Workbooks