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2006-11-09 News Release
Pharmaceutical proteins
biotech development center
New JV development center is a fully integrated technology platform for
the production of pharmaceutical proteins to the biotech industry and
scientific community.
Dutch biotechnology company Crucell N.V. and technology partner DSM Biologics,
a business unit of DSM Pharmaceutical Products announces the opening of
the PERCIVIA PER.C6* Development Center, a product of an earlier announced
joint venture between the two Dutch companies. The new facility, with
approximately 47,000 square feet of laboratory space, located at 1 Hampshire
Street, Cambridge, Mass., USA, is a joint venture between DSM and Crucell,
and is exclusively dedicated to research and development of PER.C6 human
cell line platform.
Crucell
is a biotechnology company focused on research, development and worldwide
marketing of vaccines and antibodies that prevent and treat infectious
diseases.
Find Information and Suppliers of pharmaceutical
proteins.
PERCIVIA was conceived and designed to further develop the PER.C6 cell
line and provide turnkey solutions for the production of pharmaceutical
proteins to licensees utilizing the PER.C6 human cell line in the biotech
industry - currently a $35 billion USD industry. This technology platform
will comprise cell line generation technology, cell culture media development,
upstream and downstream processes, equipment selection, scale-up, technology
transfer, and regulatory support.
"PERCIVIA's state-of-the-art facility will generate the know-how
and support for the use of PER.C6 cells in the manufacturing of human
therapeutic proteins," said Dr. Marco Cacciuttolo, Chief Executive
Officer of PERCIVIA.
"With over 20 companies licensing the technology for protein and
monoclonal antibody production, we anticipate that the PER.C6 cell line
will become the leading choice for many biotechnology and pharmaceutical
companies, and PERCIVIA is well-positioned to support this growing market."
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Crucell’s PER.C6* cell
line is derived from a single, human retina-derived cell,
which was purposely immortalized using recombinant DNA
technology. image: Crucell |
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"The tremendous promise and potential of PER.C6 technology has become
apparent not only from our own work, but particularly from customer and
licensee feedback," commented Leendert Staal, Chief Executive Officer
of DSM Pharmaceutical Products. "This R&D center dedicated to
the further development of the PER.C6 technology platform will play a
key role in establishing the PER.C6 cell line as a new standard in the
production of human therapeutic proteins."
DSM
Biologics,
a business unit of DSM Pharmaceutical Products, is a leading provider
of manufacturing technology and services to the biopharmaceutical industry.
Ronald H.P. Brus, President & CEO of Crucell added: "Our current
and future PER.C6 technology licensees will be able to continuously benefit
from the know-how generated in the PERCIVIA PER.C6 Development Center.
The recombinant protein market is very large and still growing, and we
believe that this center will provide an important service to licensees
in this progressive industry."
The PER.C6 technology platform and protein production
The PER.C6 technology platform, optimized at PERCIVIA, will be comprised
of cell line generation technology, cell culture media development, upstream
and downstream processes, equipment selection, scale-up, technology transfer,
and regulatory support.
The key benefits of the PER.C6 cell line are:
. Rapid development - Crucell, DSM and their vendor network have worked
closely together to offer customers a serum-free, suspension adapted PER.C6
cell line in three months, and move from clone to Phase I material in
less than 12 months.
. Regulatory acceptance & safety in the clinic - Many PER.C6 produced
products have been tested in clinical trials, with several heading towards
Phase III trials. In the clinic, not a single adverse event has been documented
due to the use of PER.C6 produced materials. The complete history of the
cell line is documented in an FDA-filed Biologics Master File (BMF), in
greater detail than any other cell line.
. Human-like glycosylation - PER.C6 cells provide human-like glycosylation
for monoclonal antibodies. Products produced in rodent-derived cell lines,
such as NS/0 and CHO, do not have human glycosylation profiles like the
PER.C6 cell line.
. Scalable and high yields - The PER.C6 cell line has successfully performed
up to a 20,000L scale. For IgG1 monoclonal antibodies, production levels
of 3.5g/L (and up to 40pg/cell/day) have been achieved with PER.C6 cells.
Find information about DSM.
Read a recent press release about - Next generation DSM ballistic
polyethylene fibers, that provide more stopping power, have been selected
by American Body Armor for their top protective vest model.
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