CROs Qualyst, Hepregen Partner To Develop HepatoPac B-CLEAR For Liver Transporter Analysis
By Cyndi Root
Qualyst Transporter Solutions and Hepregen Corporation, contract research organizations (CROs) have partnered to co-develop and co-market Qualyst’s HepatoPac B-CLEAR assay kits. The move, announced in a press release, advances predictive and mechanistic hepatic transporter analysis used in drug transport, hepatotoxicity, and hepatic induction studies.
Dr. Vincent Zurawski, president and chief executive of Hepregen, said, "This important product development and marketing partnership represents the realization of a mutually conceived goal that was set more than a year ago. The products resulting from the partnership will enable our customers the unique ability to enhance their understanding of drug candidate interaction with hepatic transporters.”
Qualyst and Hepregen Agreement
Under the terms of the agreement between Qualyst and Hepregen, the companies will collaborate to develop the capabilities of the B-CLEAR assay kits containing human or animal hepatocytes (liver cells). Development will focus on optimizing Hepragen’s tissue culture plates using hepatobiliary methodology and intracellular concentration measurement. Both companies will have the rights to market the assays.
Christopher Black, CEO of Qualyst, commented, “Studies require the highest quality hepatocytes, since these cells must be fully-functioning in order to achieve physiologic intracellular concentrations.”
B-CLEAR
B-Clear hepatic transporter assays allow investigators to differentiate compounds according to biliary excretion, intracellular concentration, and the degree of hepatic accumulation. Prior to running clinical trials, scientists can predict human biliary clearance potential in vivo, evaluate interspecies differences in liver uptake and hepatic accumulation, identify drug-drug interactions, and improve hepatotoxicity predictions.
In May 2014, SOLVO Biotechnology licensed B-CLEAR to serve its customers in Europe and Asia. SOLVO contracted with Qualyst to use the assays for the past few years before the license arrangement.
About Qualyst
Qualyst Transporter Solutions was built on the research of the University of North Carolina (UNC) School of Pharmacy professors, Kim Brouwer, PharmD, Gary Pollack, PhD, and Dhiren Thakker, PhD. Qualyst clients have included AstraZeneca, Johnson & Johnson, Pfizer, Gilead, Millennium, and Intermune. CRO Covance also utilizes Qualyst technologies in its service to the pharmaceutical industry. Covance announced the license in 2007, stating that the technologies allowed it to begin offering pharmacokinetic studies.