What is B-CLEAR®?
The B-CLEAR® technology refers to a patented methodology that, when applied to properly functioning hepatocytes in culture, opens the bile pockets (analogous to bile canaliculi in vivo), allowing the measurement of material that has been transported from inside the cell. Measurement of biliary efflux allows us to exclusively evaluate biliary clearance and biliary transporter interactions, as well as perform cellular mass balance measurements. The three main B-CLEAR® technology platforms are patented in 45 countries worldwide.
Data from the B-CLEAR® model has been used in a variety of ways including in the prediction of clinically relevant drug interactions and in regulatory submissions to the FDA in support of mechanisms of transporter interactions and hepatotoxicity.
What is an integrated hepatic model and why is it important?
An integrated in vitro model maintains physiologic cellular components and processes at in vivo-relevant amounts. In the sandwich-cultured hepatocyte model, relevant drug transporter proteins (uptake and efflux), as well as drug metabolizing enzymes (Phase I and II), are expressed, maintained, and functioning together in the same system. The figure below graphically represents this concept.
To obtain a true in vivo understanding of hepatic disposition and drug interactions, all three major clearance pathways (uptake, metabolism, and efflux) must be present, ideally, within the same model system. A system that integrates these three pathways together can assess cellular compensation effects, which mirrors the in vivo situation. In addition, the presence of functional clearance pathways together means that studies to assess induction, hepatotoxicity, cholestasis, clearance, or drug interactions automatically generate physiologic concentrations and metabolites, thereby removing the need to artificially estimate or guess appropriate intracellular concentrations or conditions.
News & Events
- Qualyst Transporter Solutions announces agreement to apply B-CLEAR® to Hepregen's unique HepatoPacTM system with key customers.
- Qualyst Transporter Solutions will be at SOT this year in San Antonio! Come check out our booth at #553 and our BSEP and Bile Acid posters at #2572 (Thurs) and #1059 (Tues).
- Qualyst Transporter Solutions is pleased to announce the Transporter CertificationTM of a cryopreserved lot of hepatocytes from Triangle Research Labs! Not only can TRL’s cryopreserved hepatocyte lot GC-4008 be used with confidence for induction, toxicity, and metabolism studies knowing that the transporter function is certified, these hepatocytes can also be used for B-CLEAR® studies.
- Qualyst Transporter Solutions,LLC Announces New Alliance with GenoMembrane.
- Qualyst Transporter Solutions is pleased to announce the Transporter Certification™ of a cryopreserved lot of hepatocytes from IVAL! Not only can IVAL’s cryopreserved hepatocyte lot TC-HH-1025 be used with confidence for induction, toxicity, and metabolism studies knowing that the transporter function is certified, these hepatocytes can also be used for B-CLEAR® studies.
- Qualyst Transporter Solutions is a proud sponsor of the 2012 Annual Meeting of the North American Hepatocyte Research Association being held during ISSX on Tuesday, October 16th at 5pm in the DeSoto Room of the Hilton Anatole.
- Visit us at the ISSX 18th North American Regional Meeting – Booth #219,
Hilton Anatole Dallas Hotel,
Dallas, Texas, USA
October 14 - 18, 2012
- FDA Services Press Release, 6/18/2012
- Formation of Qualyst Transporter Solutions, LLC Announced, 4/11/2012
- Press Release, 4/13/2012