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HepatoSys, Lonza Collaborate on Liver Cell Research

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By Barry Teater, NCBiotech Writer

Two North Carolina bioscience companies with expertise in human liver cells are joining forces to improve the quantity and quality of those cells for use in pharmaceutical research and drug testing.

Charlotte-based HepatoSys has received a $366,000 Phase I grant from the federal Small Business Innovation Research (SBIR) program to fund the research. It will team up with Lonza which acquired Triangle Research Labs of Research Triangle Park in June 2016 to explore HepatoSys’ patented technology for rejuvenating donated human livers that aren’t healthy enough for organ transplants.

Pharmaceutical companies spend about $1.5 billion a year on drug testing using human liver cells, called hepatocytes, according to HepatoSys. Human cell lines, while readily available and reproducible, often lose many of their functions within minutes after livers are harvested, limiting their usefulness as pharmaceutical reagents.

“The problem is that there is a narrow window between ‘too bad to transplant’ and ‘too bad to provide viable cells,’” says Mark Clemens, Ph.D., HepatoSys’ vice president and chief scientific officer. “This is where our technology is important.”

Resuscitating ‘marginal’ livers

HepatoSys has developed a proprietary solution that can help resuscitate “marginal” livers donated by victims of fatal heart attacks.

“The liver is harvested from the donor and kept in cold storage until it gets to us,” Clemens explains. ”At this point, tissue energy stores are depleted and immediate reperfusion with blood at body temperature causes the injury to be worsened. What we do is perfuse at a reduced flow and temperature with the proprietary solution so that the liver has a chance to recover while being protected from the worsening of injury that normally occurs.”

The solution helps replace depleted energy stores, maintain membrane stability and minimize oxidation damage. HepatoSys says studies in both rodent and swine models, as well as with human livers, have indicated the technology could substantially increase the yield and quality of hepatocytes isolated from less-than-ideal livers.

Its partner in the SBIR research project, Lonza, specializes in providing hepatocytes to the pharmaceutical industry.

“Lonza is the fastest growing provider of human liver cells in the country,” Clemens says. “As such, they can provide the ‘gold standard’ for current methods for isolating human liver cells.  In addition, partnering with them can provide an immediate pathway to commercialization of the technology. We anticipate that adoption of our technology, if the project is successful, will allow them to increase the production of cells while reducing costs and increasing quality.”

Better tools for studying liver disease

A successful project could enable Lonza to generate primary hepatocytes from a larger number of donors, producing higher yields and better quality and “ultimately leading to more reliable results for our end-users,” says Maureen Bunger, Ph.D., product manager for ADME-Tox Solutions at Lonza.

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“Furthermore, such technology could mean that diseased tissue, which is generally not amenable to hepatocyte isolation, will now become a more readily available model for researchers studying key diseases such as non-alcoholic fatty liver disease and nonalcoholic steatohepatitis.”

About 30 million people – or one in 10 – suffer from some type of liver disease in the United States, according to the American Liver Foundation.

The two companies’ joint research project has two goals, Clemens says. The first is to refine and expand the technology in rats to be able to keep the liver longer and to further improve the quality of cells after isolation. The second is to apply those optimized conditions in a proof-of-concept study using human livers.

“This is where the collaboration with Lonza comes in,” Clemens says. “We will combine our technology with their standard operating procedure for cell isolation to determine what degree of improvement we can realize using marginal donor livers that would normally have a low rate of success.”

Company born at UNC Charlotte

HepatoSys was co-founded in 2005 by Clemens, a biology professor at UNC Charlotte, and Charles Lee, Ph.D., associate professor and director of the Center for Biomedical Engineering and Science at UNC Charlotte.

The private company has been funded to date by federal research grants. The North Carolina Biotechnology Center also provided a $5,000 grant to UNC Charlotte in 2012 to support an undergraduate biotechnology research fellowship for a student working with Clemens on hepatocyte cell recovery from livers.

HepatoSys won recognition in 2010 by placing first in the biotech device category of the Charlotte Research Institute's Five Ventures Competition. The company and four other winners shared $100,000 in business services.

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