
HepaLife™ Achieves 20-Fold Increase in Cell Production
for Bioartificial Liver While Reducing Labor 4-Fold
Boston, MA – July 31, 2008 – HepaLife
Technologies, Inc. (OTCBB: HPLF)
(FWB: HL1) (WKN: 500625), developing the first-of-its-kind bioartificial
liver device intended for the treatment of liver failure announced
today significant process improvements for cell manufacturing and
storage, important factors in cost-efficiently producing enough cell-based
liver devices for in-vivo trials, and ultimately, clinical application.
Efficient large-scale manufacturing of HepaLife’s patented
PICM-19 liver stem cells is a key consideration in the operation
of the Company’s bioartificial liver, since scientists anticipate
that tens of billions of cells will be needed inside the device’s
bioreactor system.
“Efficient cell manufacturing protocols in combination with
improved storage capabilities provide us with important tools in
moving us towards clinical and commercial success,” explained
Mr. Frank Menzler, President and CEO of HepaLife Technologies, Inc. “We
are very pleased with the enhanced production of our patented PICM-19
cells, an especially important achievement as we move towards in
vivo studies.”
HepaLife researchers have achieved important cell-production improvements
including a 20-fold increase in output, and a concurrent reduction
in labor intensive cell maintenance by four-fold. The improved cell
growth process make use of FDA cGMP (U.S. Food and Drug Administration’s
current Good Manufacturing Practice) compliant technology, an important
factor in allowing the Company to readily transfer the manufacturing
of its PICM-19 cells to third-party contract manufacturers.
Using the new cell production technology, HepaLife researchers initiated
pilot production of PICM-19 cells, which showed desirable liver function
characteristics such as ammonia utilization, urea production rates
and drug detoxification activities. HepaLife researchers hope to
further optimize cryopreservation protocols for these cells in order
to provide for better storage and improved viability when thawed
for use in liver support treatment.
In ongoing tests, HepaLife’s proprietary PICM-19 liver stem
cells inside the bioartificial liver have been perfused with cell
culture media, blood plasma and whole blood, an environment designed
to better mimic natural conditions for animal and human clinical
trials in preparation for anticipated in vivo studies.
Intended for the treatment of liver failure, the HepaLife™ Bioartificial
Liver device consists of three basic components: (1) a plasma filter,
separating the patient’s blood into blood plasma and blood
cells; (2) the bioreactor, a unit filled with the patented PICM-19
liver stem cell line which biologically mimics the liver’s
function; and (3), the HepaDrive™, a perfusion system for pumping
the patient's plasma through the bioreactor while controlling gas
supply and temperature for best possible performance of the cells.
ABOUT HEPALIFE TECHNOLOGIES, INC.
Based in Boston, Massachusetts, HepaLife Technologies, Inc. (OTCBB: HPLF
- News) (FWB: HL1) (WKN: 500625) is a developer of cell-based
medical technologies addressing prevalent human health concerns.
HepaLife is developing the first-of-its-kind bioartificial liver
device intended for the treatment of liver failure using the Company’s
patented PICM-19 liver stem cell line. The HepaLife™ bioartificial
liver, currently under development, is designed to serve as a supportive
device, either allowing the liver to regenerate upon acute liver
failure, or to bridge the patient's liver functions until a transplant
is available.
Utilizing its patented liver stem cell line PICM-19, HepaLife is
designing testing platforms to improve the pharmaceutical industry’s
capability to evaluate drug toxicity and possible side-effects before
pharmaceutical compounds are commercially distributed.
Any statements contained in this press release regarding our ongoing
research and development and the results attained by us to-date have
not been evaluated by the Food and Drug Administration.
For additional information, please visit www.hepalife.com.
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