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Biotranex LLC

30 Orders Completed
Monmouth Junction, New Jersey, US

About Biotranex LLC

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.

Our Services (35)


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IND-Enabling Studies

Price on request
Request a quote for more information about this service.

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In vivo Bioavailability/Bioequivalence Studies

Price on request
  • Preclinical animals


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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 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 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 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


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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 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


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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


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In vitro Metabolic Stability Assays

Price on request
  • Microsomes
  • Hepatocytes
  • S9
  • Cytosol
  • Expressed enzymes
  • Slow metabolism


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In vitro Bioavailability/Bioequivalence Studies

Price on request
  • 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


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CYP Induction Assay

Price on request
  • CYP activity
  • mRNA
  • Primary hepatocytes - human and animal


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Blood Partitioning

Price on request
  • 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


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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


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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


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Drug Absorption Studies

Price on request
  • 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


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Caco-2 Cell Lines

Price on request
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Enzyme Assays

Price on request
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Cell-Based Assays

Price on request
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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


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Toxicology

Price on request
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Project Management

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


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Cells and Tissues

Price on request
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Pharmacology & Toxicology

Price on request
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Human Primary Cells

Price on request
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Drug Discovery & Development

Price on request
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UDP-Glucuronosyltransferases (UGT) Assays

Price on request
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Organic Ion Transporter Assays

Price on request
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Sulfotransferase Assays

Price on request
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Clinical Research

Price on request

Clinical Research Services


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Pharmacology

Price on request

Pharmacology Services


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KH

Kan He

President
  • Positive review for BSEP Inhibition Assay:

    June 2018

    "It is a great experience working with Biotranex. They provide great and speedy services!"

Biotranex LLC has not received any endorsements.