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Biotranex LLC

Monmouth Junction, New Jersey, US

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.

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MDR3 Inhibition Assay
Multidrug Resistance Protein 3 Inhibition Assay
Price on request

MDR3cyte™ Inhibition Assay

MDR3cyte™ is a patent-pending assay that is the only physiologically relevant assay available to assess test agent inhibition of human multidrug resistance protein 3 (MDR3). MDR3cyte™ is a hepatocyte-based platform that measures test agent inhibition of MDR3, provides cross-species studies, and... Show more »

MDR3cyte™ Inhibition Assay

MDR3cyte™ is a patent-pending assay that is the only physiologically relevant assay available to assess test agent inhibition of human multidrug resistance protein 3 (MDR3). MDR3cyte™ is a hepatocyte-based platform that measures test agent inhibition of MDR3, provides cross-species studies, and offers the ability to investigate the effect of in situ drug metabolism on inhibition; the assay is run without radioactive reagents.

MDR3cyte™ employs a 96-well plate format with liquid chromatography-mass spectrometry quantification. The assay is accurate, reproducible, sensitive, and possesses a wide dynamic range. MDR3cyte™ was developed to be cost competitive and high-throughput.

MDR3cyte™ shows excellent correlation with drugs that cause human drug-induced liver injury (DILI) and MDR3 inhibition. MDR3cyte™ is your assay to test MDR3 inhibition and minimize the risk of unexpected DILI.

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BSEP Inhibition Assay
Bile Salt Export Pump Inhibition Assay
Price on request

BSEPcyte® Hepatocyte-Based BSEP Inhibition Assay

BSEPcyte™ is a patented assay (United States patent number 9,772,325) that offers significant advantages over bile salt export pump (BSEP) assays that use membrane vesicle preparations. BSEPcyte™ is a physiologically relevant hepatocyte-based platform that measures test agent... Show more »

BSEPcyte® Hepatocyte-Based BSEP Inhibition Assay

BSEPcyte™ is a patented assay (United States patent number 9,772,325) that offers significant advantages over bile salt export pump (BSEP) assays that use membrane vesicle preparations. BSEPcyte™ is a physiologically relevant hepatocyte-based platform that measures test agent inhibition of BSEP or Bsep, provides cross-species comparisons, and offers the ability to investigate the effect of in situ drug metabolism on inhibition; the assay is run without radioactive reagents.

BSEPcyte™ employs a 96-well plate format with liquid chromatography-mass spectrometry quantification. The assay is accurate, reproducible, sensitive, and possesses a wide dynamic range. BSEPcyte™ was developed to be cost competitive and high-throughput.

BSEPcyte™ shows excellent correlation with drugs that cause human drug-induced liver injury (DILI) and BSEP inhibition. BSEPcyte™ is your assay to test BSEP inhibition and minimize the risk of unexpected DILI.

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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
Price on request

Biotranex provides laboratory services for pharmacokinetics/metabolism/chemical toxicology studies including:

  • Animal pharmacokinetics
  • Bioanalysis
  • Drug Metabolism
  • Drug Transporters
  • Metabolite profiling
  • Structural identification of metabolites
  • Metabolic soft-spot identification
  • Reaction phenotyping studies... Show more »

Biotranex provides laboratory services for pharmacokinetics/metabolism/chemical toxicology studies including:

  • Animal pharmacokinetics
  • Bioanalysis
  • Drug Metabolism
  • Drug Transporters
  • Metabolite profiling
  • 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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Metabolite Identification
Price on request
  • LC-MS/MS structural identification, metabolic profiles, and species comparisons.
  • NMR structure elucidation
  • Radioactive or non-radioactive materials
  • LC-MS/MS structural identification, metabolic profiles, and species comparisons.
  • NMR structure elucidation
  • Radioactive or non-radioactive materials
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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:

  • BSEPcyte(R) inhibition Assay
  • MDR3cyte(R) inhibition Assay
  • Bilirubincyte(R) inhibition Assay
  • Absorptive and bidirectional permeability in MDCK or Caco-2 monolayers
  • PAMPA... Show more »

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

  • BSEPcyte(R) inhibition Assay
  • MDR3cyte(R) inhibition Assay
  • Bilirubincyte(R) inhibition Assay
  • 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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Metabolite Generation
Price on request

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

  • Glucuronide metabolites, oxidative metabolites
  • 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:

  • Glucuronide metabolites, oxidative metabolites
  • 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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CYP Inhibition Assay
Price on request
  • Screening for CYP inhibition
  • Regulatory required CYP inhibition
  • Mechanism CYP inhibition
  • Metabolism dependent CYP inhibition
  • Screening for CYP inhibition
  • Regulatory required CYP inhibition
  • Mechanism CYP inhibition
  • Metabolism dependent CYP inhibition
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In vitro Metabolic Stability Assays
Price on request
  • Microsomes
  • Hepatocytes
  • S9
  • Cytosol
  • Expressed enzymes
  • Slow metabolism
  • Microsomes
  • Hepatocytes
  • S9
  • Cytosol
  • Expressed enzymes
  • Slow metabolism
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Bioavailability and Bioequivalence Studies
Price on request
  • Preclinical animals
  • PAMPA assay
  • MDCK and Caco-2 permeability
  • Pgp and BCRP transfected cell lines
  • Preclinical animals
  • PAMPA assay
  • MDCK and Caco-2 permeability
  • Pgp and BCRP transfected cell lines
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Human Hepatocytes
Price on request
  • BSEPcyte(R) inhibition Assay
  • MDR3cyte(R) inhibition Assay
  • Bilirubincyte(R) inhibition Assay
  • Hepatocyte cytotoxicity
  • CYP induction
  • Metabolic stability
  • Metabolic profiling
  • BSEPcyte(R) inhibition Assay
  • MDR3cyte(R) inhibition Assay
  • Bilirubincyte(R) inhibition Assay
  • Hepatocyte cytotoxicity
  • CYP induction
  • Metabolic stability
  • Metabolic profiling
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CYP Induction Assay
Price on request
  • CYP activity
  • mRNA
  • Primary hepatocytes - human and animal
  • CYP activity
  • mRNA
  • Primary hepatocytes - human and animal
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Blood Partitioning
Price on request
  • Human
  • Animal
  • Human
  • Animal
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In vitro Hepatotoxicity Testing
Price on request
  • Primary hepatocytes
  • BSEPcyte(R)
  • MDR3cyte(R)
  • Bilirubincyte(R)
  • Reactive intermediates
  • Cell lines
  • Primary hepatocytes
  • BSEPcyte(R)
  • MDR3cyte(R)
  • Bilirubincyte(R)
  • Reactive intermediates
  • Cell lines
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In vitro Toxicity Testing
Price on request
  • Cell lines (over 20 cell lines available)
  • Primary hepatocytes
  • BSEPcyte(R)
  • MDR3cyte(R)
  • Bilirubincyte(R)
  • Reactive intermediates
  • Cell lines (over 20 cell lines available)
  • Primary hepatocytes
  • BSEPcyte(R)
  • MDR3cyte(R)
  • Bilirubincyte(R)
  • Reactive intermediates
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Cell Uptake/Transporter Assays
Price on request
  • Transporter phenotyping/inhibition (IC50 or Ki): uptake OATP1B1, OATP2B1, OATP1B3, OAT1, OAT3, OCT1, OCT2
  • Hepatic uptake in hepatocytes from human and animals
  • Transporter phenotyping/inhibition (IC50 or Ki): uptake OATP1B1, OATP2B1, OATP1B3, OAT1, OAT3, OCT1, OCT2
  • Hepatic uptake in hepatocytes from human and animals
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Drug Distribution Studies
Price on request
  • Plasma protein binding (cross species)
  • Tissue protein binding
  • Tissue concentration (parent and metabolites)
  • Blood/plasma partition
  • Covalent binding
  • Plasma protein binding (cross species)
  • Tissue protein binding
  • Tissue concentration (parent and metabolites)
  • Blood/plasma partition
  • Covalent binding
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Cell Lines
Price on request
  • Over 20 cell lines
  • Over 20 cell lines
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Caco-2 Cell Lines
Price on request
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Enzyme Assays
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Cell-Based Assays
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Drug Discovery
Price on request

Biotranex offers integrated drug discovery services including:

  • DMPK: comprehensive package
  • Pharmaceutics: solubility and permeability
  • Toxicology: cytotoxicity, hERG, Ames, chemical toxicity, telemetry

Biotranex offers integrated drug discovery services including:

  • DMPK: comprehensive package
  • Pharmaceutics: solubility and permeability
  • Toxicology: cytotoxicity, hERG, Ames, chemical toxicity, telemetry
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Toxicology
Price on request
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Project Management, Consulting, & Support Services
Price on request
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Regulatory Affairs Services
Price on request

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
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Cells and Tissues
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Pharmacology & Toxicology
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Human Primary Cells
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Drug Discovery & Development
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UDP-Glucuronosyltransferases (UGT) Assays
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Organic Ion Transporter Assays
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Sulfotransferase Assays
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Clinical Research
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Clinical Research Services

Clinical Research Services

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2018-04-11 11:27:20 -0700

Net Promoter Score of 9 received for In vitro Hepatotoxicity Testing.

Additional Ratings: satisfaction with deliverable: 9, satisfaction with timeliness: 9.

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