We blend the fields of cell biology, immunology, molecular biology and biochemistry to tackle complex projects in an innovative and timely manner. Simultaneously, we utilize our in-depth scientific expertise from several fields to collectively approach a particular project to complement our clients need.
Since 1995, Marin Biologic has been meeting the needs of the Pharmaceutical, Biotechnology, Diagnostic, Agricultural and Legal markets with GLP and GMP compliant assay development, validation and testing services. Marin Biologic focuses on development, validation and sample analysis in the areas of immunology, cell and molecular biology, and biochemistry and has performed sample analyses using over 100 different assays. We are compliant with U.S. FDA cGMP/GLP standards as well as ICH for all levels of clinical development and we employ these standards that are phase appropriate for your clinical development or research.
Certifications: FDA inspected
Nishida M, Teshigawara K, Niwa O, Usuda S, Nakamura T, Ralph P, Newman R, Padlan EA., 'Novel humanized anti-CD20 monoclonal antibodies with unique germline VH and VL gene recruitment and potent effector functions', Int J Oncol. 2008 Jun;32(6):1263-74.
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.
Marin Biologic provides the highly specialized insights and proven GLP/GMP knowledge needed to support a broad range of cell-based assay needs. Our veteran team has expertise with both primary cells and cell lines. In collaboration with our clients, we develop and validate custom cell-based assays with an ongoing awareness of the relevant regulatory guidelines and recommendations. 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 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
Drug effect on metabolism is measured by radioactive precursor uptake, thymidine, uridine (or uracil for bacteria), and amino acid, into DNA, RNA and proteins. Carbohydrate or lipid synthesis is similarly measured using suitable precursors. Turnover of nucleic acid or protein or the degradation of specific cell components, is measured by prelabeling (or pulse labeling) followed by a purification step and quantitation of remaining label or sometimes by measurement of chemical amounts of the component. Energy source metabolism is also analyzed for optimal cell growth.
For most studies, cell growth is measured by a homogeneous, vital dye method in which one of several choices of dye is added to cells in a 96 well plate at the conclusion of the study, incubated for increasing hours, and read directly in a plate reader. The dye is enzymatically changed in healthy cells so that development of color or fluorescence is measured using a different wavelength than the unaltered dye. Addition of a growth factor, an inhibitor or a cytotoxic factor to cells is easily read. This procedure has very few steps, has minimal manipulation of cells, and allows good reproducibility. Alternatively, uptake of 3H-thymidine is used specifically for assay of DNA synthesis, or as a more sensitive assay of cell proliferation for slow growing cells
ELISA assays are very sensitive, precise and quantitative. Some assays such as fluorescence and time-resolve fluoresence are as sensitive as radiometric assays. They can be used to measure an antigen or an antibody, or generally, any macromolecule that binds another molecule or cell. A typical format is to coat a protein on the bottom of a plastic 96 well plate, block remaining potential protein binding sites by incubation with bovine albumin, casein, or other blocking agents, add the test sample which can be in a crude mixture such as serum, wash out any material that does not bind to the first protein, and detect the bound molecule by an enzyme-conjugated specific antibody. Detection is amplified many-fold using an enzyme-linked detection system, because the substrate is continuously turned over and the product is measured. Marin Biologic uses colorimetric, fluorescent, time-resolved, and homogenous (requiring no washing step) ELISA formats.
A common method to assess the cellular immune response is to co-culture lymphocyte populations from two individuals, (e.g. two humans or two mice of different strains) where the T cells recognize the foreign cells from the other strain, activate and proliferate. One population of cells can be restricted to being stimulator cells (e.g. a preparation of tumor cells), by pretreating them with a mitotic poison (mytomycin B), thereby turning the assay into "one-way" MLR.
Proteins are purified from cell supernatants, cell extracts, tissue homogenates, or E.coli cytoplasm or inclusion bodies by various preparative precipitation, centrifugal, electrophoretic, filtration and chromatographic steps. Salt precipitation, typically with ammonium sulfate, is a convenient and gentle first step and reduces the large volume of the starting material. Subsequent steps may use centrifugation, affinity purification on an antibody or substrate column or other affinity supports and a combination of size, charge, and hydrophobic chromatography. Final steps may include reverse phase HPLC. The desired protein is identified by a bioassay or enzyme activity, immunoassay and amino acid sequencing, and quality controlled by a variety of assays (See below and Immunology). Endotoxin is measured and removed if necessary.
Northern blot analysis involves size separation of the RNA species by electrophoresis followed by identification with labeled gene-specific oligonucleotides or DNA probes. The size and abundance of the desired RNA is determined. The predominant rRNA in a total RNA preparation can also be detected by UV absorbance as a measure of intactness.
In this highly specific technique, antibodies are purified based on high-affinity binding to their ligand. The immunizing protein, antigenic peptide epitope, enzyme etc. is coupled to a column matrix, typically a form of Sepharose, and the corresponding antibody that recognizes the ligand specifically binds to the column and can be separated out from other proteins present in the sample. The antibody is eluted by acid or chaotropic reagents followed by recovery of activity. Due to the high specificity of receptor-ligand interactions, this method yields nearly pure protein with a minimal amount of purification steps.
Cells can be transfected with reporter genes that are activated when certain pathways are triggered. Pathway induction is quantitated by the reporter gene, such as the appearance of fluorescence or of an enzyme activity. These surrogate methods may be much more sensitive and rapid than detection of the primary gene response.
Marin Biologic Laboratories has not received any reviews.
Marin Biologic Laboratories has not received any endorsements.