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Lonza announces license agreement with iPS Academia Japan
September 2012
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WALKERSVILLE, Md.—Lonza Biosciences has entered into a
worldwide, non-exclusive licensing agreement with iPS Academia Japan Inc. for
its induced pluripotent stem cell
(iPSC) patent portfolio.
"This license is a strategic investment to build up a
technology
platform for the cell-therapy contract manufacturing business," says
Lukas Utiger, Lonza's chief operating officer. "Cellular therapies are the
logical progression for Lonza as we move from small molecules, then to
biologics, and now therapeutic cells. Human induced pluripotent stem cells are
widely viewed as having great potential in the field of cell therapy because
these cells have the unique ability to become any of the 220-plus cell
types in
the adult body. iPSC also can be used for autologous therapies, something that
isn't possible with embryonic stem cells. While there are some
opportunities in
the research space, we are building capabilities and expertise to support cGMP
manufacturing of iPSC-derived cellular therapies, which
we believe is a market
that offers significantly more commercial potential. We already are in
discussions with a few clients related to cGMP
manufacturing."
The partnership with iPS Academia Japan came about based on
the organization's
early work. In 2007, Dr. Shinya Yamanaka and colleagues at
Kyoto
University successfully converted adult human cells to an embryonic stem cell-like
state, producing a human induced pluripotent stem cell line. The
following
June, iPS Academic Japan was established to manage the intellectual property
stemming from this achievement.
By gaining rights to these patents, Lonza is adding to its portfolio
of cell therapy products and services that includes process
development and
assay development as well as manufacturing therapeutic cells under current Good
Manufacturing Practices (cGMP). The company is poised
to apply its expertise in
the manufacture of therapeutic cells to iPSC generation and cell banking, which
it sees as an important first milestone
necessary to bring an iPSC-based
therapy to the clinic.
"As the iPSC field advances and clinical
applications become
closer to reality, Lonza is ready to support our clients in navigating the
significant hurdles of process scale-up and
optimization, cGMP manufacturing
and regulatory compliance," says Utiger. "In our pluripotent stem cell
technologies group, we continue to help our
clients by 'building bridges from
research to therapy.' With this license in place, we are well positioned to
support our clients as they move from
the research laboratory to a cGMP cell
therapy suite."
Lonza's Pluripotent Stem Cell Innovation
Center, located in
Walkersville, Md., is focused on developing tools and technologies to help
translational researchers and cell-therapy developers
move iPSC technology to
clinical application, Utiger notes.
"We are currently focusing on cGMP iPSC
generation, a
cGMP-compliant PSC medium and differentiation," he says. "The majority of our
differentiation projects stem from participation in
consortiums or client
specific projects. For both, Lonza adds value as iPSC researchers move from
laboratory studies to clinical trials. Specifically,
the consortiums and
clients rely on our expertise in process development, scale-up and
clinical-grade manufacture that meets the requirements of the
regulatory
authorities."
"iPS Academia Japan is pleased to grant a non-exclusive
license to Lonza,
a worldwide leader in life science contract manufacturing.
Lonza is an ideal partner to drive iPSC technology towards commercial success,"
adds
Shosaku Murayama, president and CEO of iPS Academia Japan.
An affiliate of Kyoto University, iPS
Academia Japan's main
role is to manage and utilize the patents and other intellectual properties
held or controlled by Kyoto University and other
universities in the field of
iPSC technologies. Currently, its portfolio consists of more than 60 patent
families (the total number of patent
applications is about 220) in iPSC
technology, and about 50 license arrangements have been executed with domestic
or international
partners. Code: E091206 Back |
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