REGULATORY
GLP, GMP Compliant CRO
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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