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Alliance Pharma, Inc

17 Lee Blvd

Malvern, PA 19355 US

Alliance Pharma is unique among Contract Research Organizations (CRO) in our unparalleled ability to resolve our clients' complex development issues quickly and decisively.

Our business model has been designed to accentuate responsiveness: smaller by design, agile, adaptable, dedicated to our clients and organized to ensure that every project is managed by senior scientific staff, each of whom has more than 15 years of technical experience. What this means for our clients is more rapid turnaround, a greater attention to detail, more accurate results and extremely competitive pricing.

Alliance is committed to consistently ensuring FDA/EPA regulatory compliance. Every member of our senior management team brings to client projects extensive training and expertise acquired from industry giants as GSK, Merck, Wyeth, Covance, PharmaNet and MDS Pharma Services. Our combined expertise in the area of DMPK, such as in vitro/in vivo drug metabolism, metabolite identification, metabolism profiling, and metabolism report writing, bioanalysis, PK analysis and PK reporting has been fully incorporated into the establishment of robust laboratory quality systems.

Technical Information:

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

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