Invitrogen hepatocytes pair with Qualyst’s B-Clear

In a move that should markedly enhance the market opportunities for Qualyst’s B-Clear hepatocyte research kits and contract services, the company has agreed with Invitrogen to offer hepatocyte screening services and research products through the latter’s wholly-owned subsidiary, CellzDirect.

Lloyd Dunlap
CARLSBAD, Calif.—In a move that should markedly enhance the market opportunities for Qualyst's B-Clear hepatocyte research kits and contract services, the company has agreed with Invitrogen to offer hepatocyte screening services and research products through the latter's wholly-owned subsidiary, CellzDirect. Qualyst, a 2004 start-up, is privately held and funded and no financial details of the agreement were disclosed.

CellzDirect was launched in 2000 with a strategic focus on products and services in the hepatic market. The company was acquired by Invitrogen in January of this year.

"We've long been a customer of CellzDirect," notes Marc Sedam, Qualyst COO. "This expansion provides us with their hepatocytes and allows them to use B-Clear technology."

Sedam stresses that B-Clear provides "data on how drugs may accumulate in the liver which you can't get any other way." All new potential drugs require in vitro hepatocyte testing for toxicity risks. Determination of liver disposition and possible drug transporter interactions is a critical component of drug development. B-Clear technology is a patented system for the in vitro assessment and in vivo prediction of hepatobiliary disposition, hepatic uptake, hepatic efflux, biliary clearance and drug transport. It identifies drug-drug interactions at the level of hepatobiliary transport to assess possible clinical implications.

Dr. Chris Black, senior director of hepatic operations at CellzDirect, also commented on the long scientific connection between the two companies, "which goes back to U of C days," he notes.

The Invitrogen unit isolates cells for use by Qualyst in studying biliary excretion, an area of increasing FDA scrutiny. "The FDA is looking at inhibition, drug induction and drug transporter interaction as being more and more important," he says. Black notes that strategically hepatocytes helped fill out the company's primary cell portfolio. Invitrogen expects continued growth in the full cell area, Black states, citing last year's acquisition of an epithelial cell line.

B-Clear is a patented sandwich-cultured hepatocyte system and is the only in vitro method to predict in vivo hepatic uptake and biliary clearance, and assess drug transporter inhibition, according to Sedam.

The new hepatocyte testing system will be available as a service through Invitrogen in mid-December. The system will be available for purchase in early 2009. All B-Clear products and services continue to be available from Qualyst. DDN

Lloyd Dunlap

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