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

	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