Regulatory Details


Assay Development | Assay Validation | GLP, GMP

Assays – GLP, GMP
Assay Development – GLP, GMP

Cell Based Assays (see Cell Biology)
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.

Cytokine, Growth Factor, Antagonist (see Cell Biology, Immunology, Biochemistry)
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.

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

Enzyme Assays (see Biochemistry)
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 (see Cell Biology & Biochemistry)
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.

Compatibility Assays (see Biochemistry & Molecular Biology)
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.

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

Assay Validation – GLP, GMP

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.

IND, BLA and NDA Support
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

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