Access to Large Population of Primates
Low Cost Provider of Contract Research Services
Fast Cycle Times
Capable of Smaller Studies

GMK Bio Services specializes in Non-Human Primate toxicology services for our clients in the pharmaceutical and biotech industries, and is well qualified to perform pharmacology studies, toxicology studies and pre-clinical research studies. GMK's research team has the knowledge, experience and expertise in the fields of immunology research, vaccine research, toxicology studies and disease models.

Our research team is comprised of an integrated multi-disciplinary, multi-level, and multi-sector group of scientists. The majority of researchers have been awarded US and Japanese doctorate and masters degrees, with key researchers having both PhD and MD degrees.

Our team members each have more than fifteen year’s of experience in various large pharmaceutical companies, drug safety evaluation centers, animal research centers and other related organizations in the US, Japan and China.


NON-HUMAN PRIMATE TOXICOLOGY:


Non-human Primate Toxicology uses primates for single and repeated dose toxicity tests. Since primates are similar to humans anatomically and physiologically, primate data can be readily extrapolated to humans.

GMK provides the following non-human primate toxicology tests.

Single-Dose Toxicity Tests:
A test article is administered once at a designated dosage. Clinical signs, weight changes, and necropsy results accompanied by acute toxicity are analyzed to evaluate test article toxicity.

Repeated-Dose Toxicity Tests:
After a test article is administered repeatedly at a selected dosage to animals through a designated route, indications of toxicity are collected from various sources, notably; blood samples, urine samples, feces samples, body weight, ophthalmological examinations, and histopathological examinations. The data is used to set a No Observed Adverse Effect Level (NOAEL) to identify target organs and to define the dose response relationship.

Blood Sampling for Toxicokinetics:
Blood or urine samples can be collected after administration of a test article and sent to clients. Clients may request this service if they have the capability to conduct toxicokinetic analysis. For this service animals can be re-tested after a recovery period for the same or different test article.

Other Toxicology Services:

Body Composition
Bone Toxicity
Cardiovascular Toxicity
Chronic Toxicity
Dermal Toxicity
Frozen Tissue Sectioning
Histopathology
Immunostaining
Immunotoxicity
Infusion Toxicity
Subchronic Toxicity
Tissue Collection

Immunotoxicology Services:
Services include tests on the effect of test articles on immunosuppression, immunostimulation, antigenicity, hypersensitivity, and autoimmunity.
Antibody Response
B Cell Count and Phenotyping
CD4 & CD8 T Cell Counts and Phenotyping
Cytokines Production
NK Cell Activity
T Cell Activation and Proliferation
T Regulatory Cell Count and Function
Thymus, LN, Spleen Histology and Immune Staining

EFFICACY SCREENING TEST:

Primary and secondary screening studies are designed to provide data that are used in the prediction of the therapeutic potential of new drug candidates early in the development process.

Primary screening uses a single dose of the test article to identify active compounds and to screen for a wide range of pharmacological activity. Toxicity or lacking efficacy at this stage may lead the compound to be rejected earlier in the development process.

Secondary screenings are more involved than primary screenings and determine a dose response relationship. It is at this stage that a therapeutic area is targeted and a smaller number of compounds are tested. During the secondary screening, the group size may be increased to allow for statistical analysis of the difference between compound and control groups.

GMK provides the following Efficacy Screenings:

Anti-Hypertensive
Anti-Inflammatory
Arthritis Models
Asthma Models
Bleeding Time
Diabetes Models
Hypoglycemic Test
Inhibition of Contact Hypersensitivity
LPS-Induced TNFalpha Release

BIOTECHNOLOGY SERVICES:

Vaccine Research and Development Services:

Immunological Monitoring Assay and Biomarker Development
In vitro and In vivo Potency Assay Development
Pre-Clinical Testing in NHPs
Pre Vaccine Testing Services
Recombinant Protein & DNA Vaccine Manufacture

Recombinant Protein Therapeutics Development Services:

Analytic Assay Development
Animal Models
Batch Release and Bulk Product Test
Biomarker Development
Cell-Based Assay
Protein Characterization
Protein Purification Protocol Development
Protein Stability Test
Recombinant Protein Expression in Mammalian Cells and Bacteria: Bioreactor (Scales:SL;
  30L; 50L and 500); Waves (Scales: 1OL and 50L)
GMK Bio Contract Research Brochure
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