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Biotranex LLC

Monmouth Junction, NJ, US
New

Biotranex is a science-driven Contract Research Organization (CRO) that provides clients with a full range of ADMET and pharmacokinetic laboratory and consulting services to facilitate drug discovery and development. Services that Biotranex offers include metabolite profiling and structural elucidation; drug-drug interaction studies; CYP induction and inhibition; CYP and UGT phenotyping; transporter inhibition and phenotyping; metabolite biosynthesis; subcellular, hepatocyte, and animal studies; biotransformation; and pharmacokinetic studies. The Biotranex team of scientists has extensive collective experience in the pharmaceutical industry and proven drug discovery and development successes, as well as extensive experience with IND and NDA regulatory filings.

Biotranex LLC has not listed any services.

Drug Discovery
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Biotranex offers integrated drug discovery services including:

  • Medicinal chemistry: lead optimization
  • Biology: assay development, screening, disease models
  • DMPK: comprehensive package
  • Pharmaceutics: solubility and permeability
  • Toxicology: cytotoxicity, hERG, Ames, chemical toxicity, telemetry

Biotranex offers integrated drug discovery services including:

  • Medicinal chemistry: lead optimization
  • Biology: assay development, screening, disease models
  • DMPK: comprehensive package
  • Pharmaceutics: solubility and permeability
  • Toxicology: cytotoxicity, hERG, Ames, chemical toxicity, telemetry
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Metabolite Identification
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Metabolomics
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Metabolite Generation
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Biotranex offers services to scale up metabolite production using bioreactors and chemical synthesis:

  • Acyl glucuronides, hydroxylated metabolites and GSH/DNA adducts
  • Milligram and gram quantities for structural elucidation and activity testing
  • Animal tissue fractions and cell lines
  • Fungal and bacterial strains for metabolite formation

Biotranex offers services to scale up metabolite production using bioreactors and chemical synthesis:

  • Acyl glucuronides, hydroxylated metabolites and GSH/DNA adducts
  • Milligram and gram quantities for structural elucidation and activity testing
  • Animal tissue fractions and cell lines
  • Fungal and bacterial strains for metabolite formation
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Regulatory Affairs Services
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Biotranex provides consulting services for IND and NDA filings:

  • Conduct necessary studies to meet regulatory requirements
  • Help to formulate an IND/NDA filing strategy
  • Prepare reports and the regulatory filing documents
  • Serve as the subject matter expert

Biotranex provides consulting services for IND and NDA filings:

  • Conduct necessary studies to meet regulatory requirements
  • Help to formulate an IND/NDA filing strategy
  • Prepare reports and the regulatory filing documents
  • Serve as the subject matter expert
« Show less
CYP Inhibition Assay
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Bioavailability Studies
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In vitro Metabolic Stability Assays
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Blood Partitioning
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Human Hepatocytes
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ADME and DMPK Studies
Drug Metabolism and Pharmacokinetics
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Biotranex provides laboratory services for a comprehensive list of metabolism/chemical toxicology studies including:

  • Metabolite profiling using LC/UV, LC/MS/MS, and LC/radiodetection
  • Structural identification of metabolites
  • Metabolic soft-spot identification
  • Reaction phenotyping studies for CYP, UGT, SULT, aldehyde... Show more »

Biotranex provides laboratory services for a comprehensive list of metabolism/chemical toxicology studies including:

  • Metabolite profiling using LC/UV, LC/MS/MS, and LC/radiodetection
  • Structural identification of metabolites
  • Metabolic soft-spot identification
  • Reaction phenotyping studies for CYP, UGT, SULT, aldehyde oxidase and hydrolytic enzymes, and determination of Km and Vmax
  • Elucidation of metabolic pathways
  • Mechanistic drug development studies such as addressing metabolism-based toxicity issues
  • Metabolite identification and semi-quantitation in plasma samples of humans and animal species
  • Preparation of metabolite standards
  • Identification of reactive metabolites: GSH adduct, DNA adduct, covalent binding, protein adduct
  • Hepatoxicity using human or animal hepatocytes
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CYP Induction Assay
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In vitro Toxicity Testing
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In vitro Hepatotoxicity Testing
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Drug Distribution Studies
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Biotranex provides laboratory services to study metabolism enzymes- or transporters-mediated drug-drug interactions. We conduct studies to meet FDA and EMA guidance.

  • Individual inhibition assays of 9 CYP enzymes: IC50 and Ki determination
  • Cocktail assays of 5 major CYP enzymes: IC50 and Ki determination
  • Time dependent... Show more »

Biotranex provides laboratory services to study metabolism enzymes- or transporters-mediated drug-drug interactions. We conduct studies to meet FDA and EMA guidance.

  • Individual inhibition assays of 9 CYP enzymes: IC50 and Ki determination
  • Cocktail assays of 5 major CYP enzymes: IC50 and Ki determination
  • Time dependent CYP inhibition: kinetics, heme adduct, apoCYP adduct, MI complex
  • CYP induction in hepatocytes from human or animals
  • Identification of CYP enzymes using cDNA-expressed enzymes, chemical and antibody inhibitors, correlation with known CYP activities, Km and Vmax determination
  • Inhibition assays of UGT enzymes: IC50 and Ki determination
  • Identification of UGT enzymes
  • Identification of SULT, esterases, aldehyde oxidase and other enzymes
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Drug Transporter Assays
Price on request

Biotranex provides a full range of services to study drug absorption and transporter properties to meet the FDA and EMA Guidance:

  • Solubility at various pH and in simulated gastric and intestinal fluids
  • Absorptive and bidirectional permeability in MDCK or Caco-2 monolayers
  • PAMPA permeability
  • Mono- or bidirectional... Show more »

Biotranex provides a full range of services to study drug absorption and transporter properties to meet the FDA and EMA Guidance:

  • Solubility at various pH and in simulated gastric and intestinal fluids
  • Absorptive and bidirectional permeability in MDCK or Caco-2 monolayers
  • PAMPA permeability
  • Mono- or bidirectional permeability determination in P-gp- and BCRP-transfected cell lines
  • Transporter phenotyping/inhibition (IC50 or Ki): efflux P-gp, BCRP and BSEP; uptake OATP1B1, OATP2B1, OATP1B3, OAT1, OAT3, OCT1, OCT2
  • Hepatic uptake in hepatocytes from human and animals
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Cell Uptake/Transporter Assays
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Cell Lines
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Caco-2 Cell Lines
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Omics
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Project Management & Consulting Services
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Cell-Based Assays
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Enzyme Assays
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Clinical Research
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Biochemical Assays
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Biology
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Cells and Tissues
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Biospecimens
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Toxicology
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Clinical Laboratory Services
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Pharmacology & Toxicology
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UDP-Glucuronosyltransferases (UGT) Assays
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Organic Ion Transporter Assays
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Human Primary Cells
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Human Biospecimens
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Transporter & Cell Uptake Assays
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Drug Discovery & Development
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Biochemistry & Molecular Biology
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Clinical Hematology
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Blood Banking and Transfusion Medicine
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Transferase Assays
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