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Biotranex LLC Granted Patent for Bile Salt Export Protein BSEPcyte™ Assay

http://www.prnewswire.com/news-releases/biotranex-llc-granted-patent-for-bile-salt-export-protein-bsepcyte-assay-300531098.html

MONMOUTH JUNCTION, N.J., Oct. 4, 2017 /PRNewswire/ -- Biotranex LLC, an innovative contract research laboratory and a leader in developing and offering drug transporter assays, today announced that the United States Patent and Trademark Office (USPTO) has granted the Company United States patent number 9,772,325, covering its novel bile salt export protein (BSEP) inhibition assay that is marketed as BSEPcyte™.

Drugs that inhibit BSEP are implicated in cholestasis and drug-induced liver injuries (DILI), which has led to the costly withdrawal of several marketed drugs. A unique aspect of the BSEPcyte™ assay platform is that it utilizes hepatocytes in suspension to measure BSEP inhibition. This platform is accurate, reproducible, and flexible as well as cost competitive.

"BSEPcyte™ offers significant advantages over other currently available methodologies"

A physiologically relevant hepatocyte-based system, BSEPcyte™ allows for the measurement of drug candidate inhibition of human BSEP, provides for cross-species studies, and offers the ability to investigate the effect of drug metabolism on inhibition. Notably, this assay is also run without radioactive reagents. The BSEPcyte™ assay is a better, safer, faster option to other assays currently on the market.

Another distinguishing advantage is that the BSEPcyte™ assay can be used as part of an early screening strategy in drug discovery, or later in drug development to provide more detailed investigations, including metabolism and cross-species studies.

This novel patent is critical in the development phase of new drugs because when bile salt export protein (BSEP) liver transporter is inhibited, drug-induced liver injury (DILI) can result. Drug-induced liver injury encompasses a spectrum of toxicities ranging from mild biochemical abnormalities to acute liver failure, and in some cases, the need for a liver transplant. DILI is responsible not only for the withdrawal of several marketed drugs but also for the necessity of FDA black box warning labels.

"The role that inhibition of liver transporters, including BSEP, plays in cholestasis and drug-induced liver injury is only recently being appreciated by drug developers in the pharmaceutical and biotech industries," states Dr. Kan He. "Preclinical animal models are poor predictors of DILI in human subjects. A major cause of DILI and cholestasis is the inhibition of human bile salt export protein. Therefore, it is critical to accurately determine the inhibition potential of this human hepatic transport protein for new drug candidates."

The BSEPcyte™ assay employs a platform using suspensions of human or animal hepatocytes in a 96-well plate format with liquid chromatography-mass spectrometry quantification. The assay is reproducible, sensitive, flexible, robust, and possesses a wide dynamic concentration range. The assay shows excellent correlation with drugs found to inhibit BSEP and that may cause human cholestasis and DILI.

Dr. He further states, "We are pleased to introduce this validated BSEPcyte™ assay methodology to provide significant physiological and technical advantages over other assays, while being cost competitive."

About Biotranex LLC
Dr. Kan He, President of Biotranex LLC and inventor of the BSEPcyte™ assay, has specialized in research focused on drug metabolism, transporters, and liver toxicity in support of drug discovery and development during an extensive career. His work has evolved at Warner-Lambert Co., Dupont Pharmaceuticals, and Bristol Myers Squibb (BMS), where he played a key role in the discovery of the oral anticoagulant apixaban. Dr. He co-founded two biotech drug discovery companies prior to establishing Biotranex LLC in the United States. Dr. He's work has been published extensively in the fields of drug metabolism and transporters.

Biotranex LLC is an innovative contract service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex also offers an extensive array of drug metabolism, transport, pharmacokinetic, and analytic services to the biotech and pharmaceutical industries. The extensive collective experience in the successful discovery and development of marketed drugs allows Biotranex to apply innovative solutions to the ADME/PK needs of other companies. The company's offices are located near Princeton, New Jersey, in Monmouth Junction. http://www.biotranex.com.

Contacts:
Kan He, Ph.D. - President
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
(732) 230-3062

Thomas F. Woolf, Ph.D. - Senior Vice President
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United States Patent Granted to Biotranex for BSEPcyte™ Assay

Monmouth Junction, NJ, 11 July 2017 – Biotranex, LLC is pleased and excited to announce the allowance of its patent application entitled “Method for Measuring Bile Salt Export Transport and/or Formation Activity” Application Number 14/781520 filed on September 30, 2015 by the United States Patent and Trademark Organization (USPTO). The patent claims are directed to Biotranex’s hepatocyte suspension assay named BSEPcyte™. Dr. Kan He of Biotranex is the inventor of this novel and unique assay which allows for the measurement of inhibition of the bile salt export protein (BSEP or ABCB11) by test agents using suspensions of primary hepatocytes. Dr. He points out that BSEPcyte™ has significant advantages over other BSEP assays including:

  • Physiologically relevant hepatocyte suspension platform
  • Accurate, robust, reproducible, and customizable
  • Cross species comparison
  • In situ Metabolism capability
  • Specific LC-MS/MS quantitation of exported bile salts
  • and Cost
  • About Biotranex, LLC

    Biotranex is an innovative service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex offers an extensive array of drug metabolism, pharmacokinetics and analytical services. For additional information, please contact Dr. Kan He, President, Biotranex, LLC, 9 Deer Park Drive, Suite A-1, Monmouth Junction, NJ 08852 at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (732) 230-3062.

    SURMOUNTING THE INSURMOUTABLE IS A BIG SUCCESS AT EXPERIMENTAL BIOLOGY 2017

    Monmouth Junction, NJ, April 26, 2017. In 2016 the American Society of Pharmacology and Experimental Therapeutics (ASPET) approved a “Big Idea” initiative created and developed by Drs Kan He and Thomas F. Woolf of Biotranex and group of leading academic and industrial though leaders, for purposes of a special session to be held as part of the annual Experimental Biology (EB) meeting to address an educational need that ASPET deemed would ultimately serve the broader community of ASPET members as well as the discipline of pharmacology. The main purpose of this special session is to provide a forum for pharmacological experts to present "real world" stories recounting when, in their own experience, insurmountable problems arose that became what appeared to be an “insurmountable obstacle” in the development of a drug they and their team were developing. The presenter would then explain how critical thinking and problem-solving skills were used to overcome the problem and allow the drug development process to continue. Each session comprises three to four presentations with a follow up Q&A. The special session under the title “Surmounting the Insurmountable: Obstacles in Drug Discovery and Development – Real World Case Studies” held its inaugural session in April in Chicago as part of the EB2017 meeting and was an immediate success.

    Dr Kan He of Biotranex and Emeritus Professor Paul Hollenberg of the University of Michigan co-chaired the inaugural session. The presenters and their topics included a wide variety of challenging cases as told by experienced and notable scientists. As part of this session, Dr Kan He gave a presentation titled “Apixaban: How Volume of Distribution Became Critical in Optimizing Efficacy and Minimizing Toxicity” where he described the surprising role volume of distribution was in the discovery and development of the anti-coagulant Apixiban.

    https://www.aspet.org/About_ASPET/ASPET_BIG_IDEAS_Initiative/
    https://www.aspet.org/Annual_Meeting_EB_2017/Program/Tuesday_April_25_2017/
    http://issuu.com/aspetpublications/docs/v59_n2_6_2017_web?e=17904823/50391585

    Biotranex and Pfizer Published Positive Results for Use of the MDR3cyte™ assay in Predicting Drug-Induced Liver Injury in a Study Using 125 Pharmaceutical Drugs

    Monmouth Junction, NJ, 24 April 2017 – Biotranex, LLC announces the publication in the journal of Chemical Research in Toxicology of the research paper entitled a joint study conducted with investigators at Pfizer “Evaluating the Role of Multidrug Resistance Protein 3 (MDR3) Inhibition in Predicting Drug-Induced Liver Injury Using 125 Pharmaceuticals” Chem. Res. Toxicol., 2017, 30 (5), pp 1219–1229. http://pubs.acs.org/doi/abs/10.1021/acs.chemrestox.7b00048

    The role of bile salt export protein (BSEP) inhibition in drug-induced liver injury (DILI) has been investigated widely, while inhibition of the canalicular multidrug resistant protein 3 (MDR3) has received less attention. This transporter plays a pivotal role in secretion of phospholipids into bile and functions coordinately with BSEP to mediate the formation of bile acid-containing biliary micelles. Therefore, inhibition of MDR3 in human hepatocytes was examined across 125 drugs (70 of Most-DILI-concern and 55 of No-DILI-concern). In conclusion, avoiding physical property descriptors that highlight dual BSEP and MDR3 inhibition or testing drug candidates for inhibition of multiple efflux transporters (e.g., BSEP, MDR3, and MRPs) may be an effective strategy for prioritizing drug candidates with less likelihood of causing clinical DILI. This research was a collaboration between scientists at Biotranex and Pfizer.

    About Biotranex, LLC

    Biotranex is an innovative service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex offers an extensive array of drug metabolism, pharmacokinetics and analytical services. For additional information, please contact Dr. Kan He, President, Biotranex, LLC, 9 Deer Park Drive, Suite A-1, Monmouth Junction, NJ 08852 at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (732) 230-3062.

    Biotranex Announces the Publication of a Research Paper on Predicting Drug-Induced Liver Toxicity Employing the BSEPcyteTM Assay

    Monmouth Junction, NJ, 27 March 2017 – Biotranex, LLC announces the publication in the Journal of Toxicological Sciences of a research paper “In Vitro Drug-Induced Liver Injury Prediction: Criteria Optimization of Efflux Transporter IC50 and Physicochemical Properties", Toxicol Sci (2017) 157 (2): 487-499. (PDF)

    Drug-induced liver injury (DILI) is a severe adverse drug response which cannot always be reliably predicted in preclinical or clinical studies. Lack of observation of DILI during preclinical and clinical drug development has led to DILI being a leading cause of drug withdrawal from the market. In vitro inhibition of the bile salt export pump (BSEP) has become a major risk factor for in vivo DILI predictions, yet discrepancies exist in which methods to use and the extent to which BSEP inhibition predicts clinical DILI. The presented work in this important study focused on the optimization of DILI predictions by the hepatocyte suspension BSEPcyteTM assay. This research was a collaboration between scientists at Biotranex and Taketa.

    About Biotranex, LLC

    Biotranex is an innovative service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex offers an extensive array of drug metabolism, pharmacokinetics and analytical services. For additional information, please contact Dr. Kan He, President, Biotranex, LLC, 9 Deer Park Drive, Suite A-1, Monmouth Junction, NJ 08852 at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (732) 230-3062.

    Biotranex Announces the Presentation of BSEPcyte™ and MDR3cyte™ Assays for Screening Heptotoxic Drugs and Assessing Specie Differences

    Monmouth Junction, NJ, 24 June 2016 - Biotranex, LLC is pleased to announce the presentation by Dr. Kan He of a webinar entitled “Novel BSEP and MDR3 Assays for Screening Hepatotoxic Drugs and Species Differences” as part of a webinar series hosted by The Critical Path Institute’s Predictive Safety Testing Consortium entitled “Current trends in BSEP inhibition and perturbation to bile acid homeostasis as mechanisms of drug-induced liver injury.” (https://c-path.org/current-trends-in-bsep-inhibition-and-perturbation-to-bile-acid-homeostasis-as-mechanisms-of-drug-induced-liver-injury/)

    About Biotranex, LLC

    Biotranex is an innovative service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex offers an extensive array of drug metabolism, pharmacokinetics and analytical services. For additional information, please contact Dr. Kan He, President, Biotranex, LLC, 9 Deer Park Drive, Suite A-1, Monmouth Junction, NJ 08852 at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (732) 230-3062.

    Biotranex Announces the Presentation of Novel BSEP and MDR3 Assays Using Primary Hepatocytes for Screening DILI Drugs and Species Differences at the Experimental Biology 2016 Annual Meeting in San Diego

    Monmouth Junction, NJ, 16 May 2016 - Biotranex, LLC is pleased to announce the presentation of a talk at the Experimental Biology (EB) annual meeting in San Diego by Dr Kan He entitled “Novel BSEP and MDR3 Assays Using Primary Hepatocytes for Screening DILI Drugs and Species Differences.” Hepatic multidrug resistance protein 3 (MDR3, ABCB4) and bile salt export pump protein (BSEP, ABCB11) are primarily responsible for biliary secretion of phosphatidylcholine and bile salts, respectively. Accumulated evidence indicates that inhibition of MDR3 and BSEP activities is associated with drug-induced liver injury (DILI). BSEP inhibition assay employing membrane vesicles prepared from BSEP transfected insect cells has issues of physiological relevance, while the BSEP inhibition assay using human sandwich cultured hepatocytes (SCH), has limitations due to technical complexly, reproducibility, low throughput, and high cost. Current MDR3 inhibition assays include transfected cell lines and membrane vesicles prepared from MDR3 transfected insect cells. These MDR3 assays also suffer from issues of physiological relevance. Here we presented data supporting the development and validation of BSEPcyte™ and MDR3cyte™ assays and the application of these assays to testing DILI drugs and species differences. These results showed the physiological relevance of BSEPcyte™ and MDR3cyte™, in vitro in vivo extrapolation, accuracy, reproducibility, large dynamic range and ability to measure in situ metabolism of test DILI drugs. Cross species studies show differences in BSEP inhibition for several test DILI drugs that may explain, at least in part, species differences in DILI.

    BSEPcyte™ and MDR3cyte™ are patent-pending assays that offer significant advantages over other currently available methodologies. They are both physiologically relevant hepatocyte-based systems that allow measurement of drug candidate inhibition of human BSEP and MDR3, provide for cross-species studies, and offer the ability to investigate the effect of drug metabolism on inhibition; both assays are also run without radioactive reagents.

    About Biotranex, LLC

    Biotranex is an innovative biotechnology discovery and service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex also offers an extensive array of drug metabolism, pharmacokinetics and analytical services. For additional information, please contact Dr. Kan He, President, Biotranex, LLC, 9 Deer Park Drive, Suite A-1, Monmouth Junction, NJ 08852 at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (732) 230-3062.

    Biotranex Announces the Presentation of BSEPcyte™ and MDR3cyte™: Novel BSEP and MDR3 Inhibition Assays for Screening DILI Drugs at the 2016 Annual Workshop and Conference: Novel In Vitro ADMET Technologies for Drug Development in Malden, MA

    Monmouth Junction, NJ, 16 May 2016 - Biotranex, LLC is pleased to announce the presentation of a talk at the 2016 Annual Workshop and Conference: Novel In Vitro ADMET Technologies for Drug Development in Malden, MA by Dr Kan He entitled “BSEPcyte™ and MDR3cyte™ Novel BSEP and MDR3 Inhibition Assays for Screening DILI Drugs.” Hepatic multidrug resistance protein 3 (MDR3, ABCB4) and bile salt export pump protein (BSEP, ABCB11) are primarily responsible for biliary secretion of phosphatidylcholine and bile salts, respectively. Accumulated evidence indicates that inhibition of MDR3 and BSEP activities is associated with drug-induced liver injury (DILI). The presentation described the development and validation of BSEPcyte™ and MDR3cyte™ assays and the application of these assays to testing DILI drugs and species differences. Specifically, the presentation showed experimental results on the physiological relevance of BSEPcyte™ and MDR3cyte™, in vitro in vivo extrapolation, accuracy, reproducibility, large dynamic range and ability to measure in situ metabolism of test drugs. Cross species studies show differences in BSEP inhibition for several test DILI drugs that may explain, at least in part, species differences in DILI.

    BSEPcyte™ and MDR3cyte™ are patent-pending assays that offer significant advantages over other currently available methodologies. They are both physiologically relevant hepatocyte-based systems that allow measurement of drug candidate inhibition of human BSEP and MDR3, provide for cross-species studies, and offer the ability to investigate the effect of drug metabolism on inhibition; both assays are also run without radioactive reagents.

    About Biotranex, LLC

    Biotranex is an innovative biotechnology discovery and service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex also offers an extensive array of drug metabolism, pharmacokinetics and analytical services. For additional information, please contact Dr. Kan He, President, Biotranex, LLC, 9 Deer Park Drive, Suite A-1, Monmouth Junction, NJ 08852 at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (732) 230-3062.

    Biotranex Announces the Publication of “Inhibition of bile salt transport by drugs associated with liver injury in primary hepatocytes from human, monkey, dog, rat, and mouse” in Chemico-Biological Interactions

    Monmouth Junction, NJ, 16 May 2016 - Biotranex, LLC is pleased to announce the online publication of the paper entitled “Inhibition of bile salt transport by drugs associated with liver injury in primary hepatocytes from human, monkey, dog, rat, and mouse” by Drs Jie Zhang (US FDA), Kan He (Biotranex, LLC) et al. in Chemico-Biological Interactions 2016 Mar 19 pii: S0009-2797(16)30089-8. doi: 10.1016/j.cbi.2016.03.019. [Epub ahead of print]. Interference of bile salt transport is one of the underlying mechanisms for drug-induced liver injury (DILI). We developed a novel bile salt transport activity assay involving in situ biosynthesis of bile salts from their precursors in primary human, monkey, dog, rat, and mouse hepatocytes in suspension as well as LC-MS/MS determination of extracellular bile salts transported out of hepatocytes. The assay was used to test 86 drugs for their potential to inhibit bile salt transport activity in human hepatocytes, which included 35 drugs associated with severe DILI (sDILI) and 51 with non-severe DILI (non-sDILI). Approximately 60% of the sDILI drugs showed potent inhibition (with IC50 values <50 µM), but only about 20% of the non-sDILI drugs showed this strength of inhibition in primary human hepatocytes and these drugs are associated only with cholestatic and mixed hepatocellular cholestatic (mixed) injuries. Twenty-four drugs were also tested in monkey, dog, rat, and mouse hepatocytes. Species differences in potency were observed with mouse being less sensitive than other species to inhibition of bile salt transport. In summary, a novel assay has been developed using hepatocytes in suspension from human and animal species that can be used to assess the potential for drugs and/or drug-derived metabolites to inhibit bile salt transport and/or formation activity. Drugs causing sDILI, except those by immune-mediated mechanism, are highly associated with potent inhibition of bile salt transport.

    BSEPcyte™ and MDR3cyte™ are patent-pending assays that offer significant advantages over other currently available methodologies. They are both physiologically relevant hepatocyte-based systems that allow measurement of drug candidate inhibition of human BSEP and MDR3, provide for cross-species studies, and offer the ability to investigate the effect of drug metabolism on inhibition; both assays are also run without radioactive reagents.

    About Biotranex, LLC

    Biotranex is an innovative biotechnology discovery and service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex also offers an extensive array of drug metabolism, pharmacokinetics and analytical services. For additional information, please contact Dr. Kan He,

    Biotranex Announces the Presentation of Individual Variations of MDR3 and BSEP Activity in Human Hepatocytes at the Society of Toxicology 2016 Annual Meeting in New Orleans

    Monmouth Junction, NJ, 12 May 2016 - Biotranex, LLC is pleased to announce the presentation of a poster at the Society of Toxicology Annual Meeting in New Orleans by Dr Kan He et al. entitled “Individual Variations of MDR3 and BSEP Activity in Human Hepatocytes.” Hepatic multidrug resistance protein 3 (MDR3, ABCB4) and bile salt export pump protein (BSEP, ABCB11) are primarily responsible for biliary secretion of phosphatidylcholine and bile salts, respectively. Loss-of-function mutations of either BSEP or MDR3 cause severe liver injury, leading to hepatic failure and in some cases death. Accumulated evidence indicates that inhibition of MDR3 and BSEP activities is associated with DILI. Individual variability of MDR3 and BSEP activities in hepatocytes was evaluated from 12 individual human donors using MDR3cyte™ and BSEPcyte™ assays. The activity of MDR3 or BSEP was found to vary by approximately 10-fold among these individuals. The hepatocytes from some donors showed substantially lower activity for MDR3 or BSEP, suggesting that they may be predisposed to DILI. No apparent correlation was observed in activities between MDR3 and BSEP. In addition, there was no correlation between MDR3 mRNA or BSEP mRNA and MDR3 and BSEP activities, respectively. This is the first study to investigate individual variations in functional activity and mRNA levels of MDR3 and BSEP and supports the use of pooled primary hepatocytes to measure drug candidate MDR3 and BSEP inhibition. Both BSEPcyte™ and MDR3cyte™ assays offer the advantage of using pooled hepatocyte suspensions.

    BSEPcyte™ and MDR3cyte™ are patent-pending assays that offer significant advantages over other currently available methodologies. They are both physiologically relevant hepatocyte-based systems that allow measurement of drug candidate inhibition of human BSEP and MDR3, provide for cross-species studies, and offer the ability to investigate the effect of drug metabolism on inhibition; both assays are also run without radioactive reagents.

    About Biotranex, LLC

    Biotranex is an innovative biotechnology discovery and service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex also offers an extensive array of drug metabolism, pharmacokinetics and analytical services. For additional information, please contact Dr. Kan He, President, Biotranex, LLC, 9 Deer Park Drive, Suite A-1, Monmouth Junction, NJ 08852 at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (732) 230-3062.

    Biotranex Announces New and Improved Bile Salt Export protein (BSEP) and Multidrug Resistance Protein 3 (MDR3) Inhibition Assays

    Monmouth Junction, NJ, 8 March 2016 - Biotranex, LLC is pleased to announce the availability of two new assay methodologies for measuring the inhibition of the bile salt export protein (BSEP) and the multidrug resistance protein 3 (MDR3) liver transporters. Drug-induced liver injury (DILI) encompasses a spectrum of toxicities ranging from mild biochemical abnormalities to acute liver failure, and in some cases the need for a liver transplant. DILI is responsible for the withdrawal of several marketed drugs as well as the necessity for FDA black box warning labels. Preclinical animal models are poor predictors of DILI in human subjects. A major cause of DILI and cholestasis is the inhibition of either or both human BSEP and MDR3 hepatic transporters. Therefore, it is critical to accurately determine the inhibition potential for drug candidates of these human hepatic transport proteins.

    BSEPcyte™ and MDR3cyte™ are patent-pending assays that offer significant advantages over other currently available methodologies. They are both physiologically relevant hepatocyte-based systems that allow measurement of drug candidate inhibition of human BSEP and MDR3, provide for cross-species studies, and offer the ability to investigate the effect of drug metabolism on inhibition; both assays are also run without radioactive reagents.

    The BSEPcyte™ and MDR3cyte™ assays employ a platform using suspensions of human and animal hepatocytes in a 96-well plate format with liquid chromatography-mass spectrometry quantification. Both assays are reproducible, sensitive, flexible, robust, and possess wide dynamic concentration ranges. The assays show excellent correlation with drugs found to inhibit BSEP and MDR3 that may cause human cholestasis and DILI.

    “The role that inhibition of liver transporters, including BSEP and MDR3, play in cholestasis and drug-induced liver injury is only now being appreciated by drug developers in the pharmaceutical and biotech industries. We are pleased to introduce these validated BSEPcyte™ and MDR3cyte™ assay methodologies that provide significant physiological and technical advantages over other assays, while being cost competitive,” states Dr. Kan He, President of Biotranex.

    About Biotranex, LLC

    Biotranex is an innovative biotechnology discovery and service company that commercializes novel and proprietary assays for research in hepatic transport, cholestasis, drug-induced liver injury, drug interactions, and drug metabolism. Biotranex also offers an extensive array of drug metabolism, pharmacokinetics and analytical services. For additional information, please contact Dr. Kan He, President, Biotranex, LLC, 9 Deer Park Drive, Suite A-1, Monmouth Junction, NJ 08852 at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (732) 230-3062.

    Publications ^

    Aleo MD, Shah F, He K, Bonin PD, Rodrigues AD. Evaluating the Role of Multidrug Resistance Protein 3 (MDR3) Inhibition in Predicting Drug-Induced Liver Injury Using 125 Pharmaceuticals. Chem Res Toxicol. 2017 May 15;30(5):1219-1229. doi: 10.1021/acs.chemrestox.7b00048. Epub 2017 May 4. PubMed PMID: 28437613. http://pubs.acs.org/doi/abs/10.1021/acs.chemrestox.7b00048

    Yucha RW, He K, Shi Q, Cai L, Nakashita Y, Xia CQ, Liao M. In Vitro Drug-Induced Liver Injury Prediction: Criteria Optimization of Efflux Transporter IC50 and Physicochemical Properties. Toxicol Sci. 2017 Jun 1;157(2):487-499. doi:10.1093/toxsci/kfx060. PubMed PMID: 28369588. https://academic.oup.com/toxsci/article-abstract/157/2/487/3092345/In-Vitro-Drug-Induced-Liver-Injury-Prediction?redirectedFrom=fulltext

    Zhang J, He K, Cai L, Chen YC, Yang Y, Shi Q, Woolf TF, Ge W, Guo L, Borlak J, Tong W. Inhibition of bile salt transport by drugs associated with liver injury in primary hepatocytes from human, monkey, dog, rat, and mouse. Chem Biol Interact. 2016 Mar 19. pii: S0009-2797(16)30089-8. doi:10.1016/j.cbi.2016.03.019. [Epub ahead of print] PubMed PMID: 27000539. http://www.sciencedirect.com/science/article/pii/S0009279716300898

    Cheng Y, Woolf TF, Gan J, He K. In vitro model systems to investigate bile salt export pump (BSEP) activity and drug interactions: A review. Chem Biol Interact. 2015 Dec 10. pii: S0009-2797(15)30131-9. doi: 10.1016/j.cbi.2015.11.029. [Epub ahead of print] PubMed PMID: 26683212. http://www.sciencedirect.com/science/article/pii/S0009279715301319

    Collet JP, Funck-Brentano C, Prats J, Salem JE, Hulot JS, Guilloux E, Hu MY, He K, Silvain J, Gallois V, Brugier D, Anzaha G, Galier S, Nicolas N, Montalescot G. Intravenous Clopidogrel (MDCO-157) Compared with Oral Clopidogrel: The Randomized Cross-Over AMPHORE Study. Am J Cardiovasc Drugs. 2016 Feb;16(1):43-53. doi: 10.1007/s40256-015-0145-0. PubMed PMID: 26386578. http://link.springer.com/article/10.1007%2Fs40256-015-0145-0

    He K, Cai L, Shi Q, Liu H, Woolf TF. Inhibition of MDR3 Activity in Human Hepatocytes by Drugs Associated with Liver Injury. Chem Res Toxicol. 2015 Oct 19;28(10):1987-90. doi: 10.1021/acs.chemrestox.5b00201. Epub 2015 Sep 15. PubMed PMID: 26335978. http://pubs.acs.org/doi/10.1021/acs.chemrestox.5b00201

    Xia Q, Ma L, He X, Cai L, Fu PP. 7-glutathione pyrrole adduct: a potential DNA reactive metabolite of pyrrolizidine alkaloids. Chem Res Toxicol. 2015 Apr 20;28(4):615-20. doi: 10.1021/tx500417q. Epub 2015 Mar 31. PubMed PMID: 25768656. http://pubs.acs.org/doi/abs/10.1021/tx500417q

    Liu Y, Wu H, Chong Y, Wamer WG, Xia Q, Cai L, Nie Z, Fu PP, Yin JJ. Platinum Nanoparticles: Efficient and Stable Catechol Oxidase Mimetics. ACS Appl Mater Interfaces. 2015 Sep 9;7(35):19709-17. doi: 10.1021/acsami.5b05180. Epub 2015 Aug 28. PubMed PMID: 26305170. http://pubs.acs.org/doi/10.1021/acsami.5b05180

    Xia Q, Chiang HM, Yin JJ, Chen S, Cai L, Yu H, Fu PP. UVA photoirradiation of benzo[a]pyrene metabolites: induction of cytotoxicity, reactive oxygen species, and lipid peroxidation. Toxicol Ind Health. 2015 Oct;31(10):898-910. doi: 10.1177/0748233713484648. Epub 2013 Apr 3. PubMed PMID: 23552265. http://tih.sagepub.com/content/31/10/898.long

    Zhao Y, Wang S, Xia Q, Gamboa da Costa G, Doerge DR, Cai L, Fu PP. Reaction of dehydropyrrolizidine alkaloids with valine and hemoglobin. Chem Res Toxicol. 2014 Oct 20;27(10):1720-31. doi: 10.1021/tx5002139. Epub 2014 Sep 11. PubMed PMID: 25211425. http://pubs.acs.org/doi/abs/10.1021/tx5002139

    Xia Q, Zhao Y, Von Tungeln LS, Doerge DR, Lin G, Cai L, Fu PP. Pyrrolizidine alkaloid-derived DNA adducts as a common biological biomarker of pyrrolizidine alkaloid-induced tumorigenicity. Chem Res Toxicol. 2013 Sep 16;26(9):1384-96. doi: 10.1021/tx400241c. Epub 2013 Aug 26. PubMed PMID: 23937665. http://pubs.acs.org/doi/abs/10.1021/tx400241c

    Zhao Y, Xia Q, Gamboa da Costa G, Yu H, Cai L, Fu PP. Full structure assignments of pyrrolizidine alkaloid DNA adducts and mechanism of tumor initiation. Chem Res Toxicol. 2012 Sep 17;25(9):1985-96. doi: 10.1021/tx300292h. Epub 2012 Aug 16. PubMed PMID: 22857713. http://pubs.acs.org/doi/abs/10.1021/tx300292h

    Modi BG, Neustadter J, Binda E, Lewis J, Filler RB, Roberts SJ, Kwong BY, Reddy S, Overton JD, Galan A, Tigelaar R, Cai L, Fu P, Shlomchik M, Kaplan DH, Hayday A, Girardi M. Langerhans cells facilitate epithelial DNA damage and squamous cell carcinoma. Science. 2012 Jan 6;335(6064):104-8. doi: 10.1126/science.1211600. PubMed PMID: 22223807; PubMed Central PMCID: PMC3753811. http://science.sciencemag.org/content/335/6064/104.long

    Patents ^

    WO 2014/200816 A1“Method for Measuring Bile Salt Export Transport and/or Formation Activity” Biotranex, LLC, 18 December 2014

    US 2016/0054305 A1 “Method for Measuring Bile Salt Export Transport and/or Formation Activity” Biotranex, LLC, 25 February 2016

     


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