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Bioanalytical testing, Drug Metabolism, Bio-pharmaceutical Services, Ligand Binding Assay Services, GLP LC-MS and LC-MS/MS bio-analytical method development and validation for new drugs, metabolites, or generic drug assay, Quantitative analysis of active drug and its metabolites in biological samples (human and animal plasma, tissue, urine, bile, and feces) using protein precipitation, LLE, SPE techniques. Neurotransmitter and other polar compound analysis, Analysis of enantiomers of drugs or metabolites, Bioanalytical support for the evaluation of Pharmacokinetic/ toxicokinetic (PK/TK) properties including bioavailability/bioequivalence (BA/BE) sample analysis. Non-GLP Bioanalytical Support, Bioanalytical support for in vivo PK screening and terminal exposure studies (cassette dosing, microdosing, receptor occupancy, microdialysis, Bioanalytical support for in vitro screening (plasma protein binding, metabolic stability, PGP efflux, Cyp induction and inhibition, phenotyping), Drug Substances Analysis, Drug substance/drug product stability, degradant and impurity investigation, Certificate of Analysis (COA), re-certification services for test substances and reference standards in both GLP and non-GLP projects, Customized analytical service programs designed according to sponsor's specific requirements, Metabolite Profiling Studies, Metabolite profiling, characterization, and structure identification utilizing LC-MS/MS in combination with radioactive detector, Metabolite isolation and purification with structural elucidation, Predict metabolic routes and the potential toxicity, Structural characterization of major metabolites, Species comparisons in vitro for selection of an appropriate animal model for pre-clinical studies, Support NDA filing, Rational drug design, In Vitro Metabolism Studies, Using microsomes, S9, Cyp450 isozyme and hepatocytes from human and other species, Anticipating the behavior of lead compounds in vivo and potential drug-drug interactions and inhibition, Discriminating and prioritizing lead compounds for successful clinical development, Identifying enzymes involved in metabolism of test compounds (Phenotyping), Metabolic stability, In Vivo Metabolism Studies, Establish the relevance of the animal models in evaluating the potential human toxicity of the compound, Verify that the major human metabolites formed are also formed in the toxicological model species, Evaluate possible contributions to adverse effects (reactive metabolites) and route of metabolism,Quantitative immunoassay: ELISA and ECL (MSD SECTOR Imager 6000), Biomarker assay development, validation and sample analysis, PK assessment for biotherapeutics, Immunogenicity testing for anti-drug antibody (ADA), Cytokine induction, kinase and receptor activation and signal transduction, Receptor blocking-based and cell-based neutralization assay, Cytotoxicity: LDH assay, MTS assay and apoptosis assay, Bioprocess contaminant (HCP, protein A, insulin) detection by immunoassay, In vitro functional cell-based assays (cell adhesion, migration, proliferation, tube formation) for drug testing: potency, efficacy and synergism determination , Immunocytochemistry
17 Lee Blvd
Malvern, PA 19355 US