DSM Biologics and Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX)
today announce another breakthrough in the production of IgG antibodies using
PER.C6® technology. By employing the PER.C6® human cell line and proprietary
XD™ technology, a record yield of over 27 grams per liter has been achieved.
In March 2008 a yield of 15 grams per liter was reported.
This milestone is the new manufacturing paradigm for mammalian cell culture to
produce protein products effectively, where the industry has struggled to date
with low yields and unstable platforms. This record surpasses all other
production systems including those previously set by PER.C6® technology
itself.
The use of PER.C6® technology will clearly impact cost of goods for marketed
products and reduce the risk of premature high capital expenditures. Higher
yields mean smaller footprints for facilities, reduced risk in drug
development, higher utilization of facilities and better chance of success.
Drugs that would otherwise not be brought to market because they are too
expensive to produce, may now find a vehicle for commercialization. More so,
the glycosylation of monoclonal antibodies and proteins, produced using
PER.C6® technology, is fully human.
Scientists at the PERCIVIA PER.C6® development center, a joint venture between
DSM and Crucell, have shown that they can reproducibly manufacture a record
amount of product with over 95% viability and unchanged product quality. This
accomplishment was achieved using standard bioreactor equipment and readily
available cell culture medium. The result of this effort provides the entire
biotechnology industry with a reliable production platform to economically
manufacture large amounts of therapeutic proteins with ease.
Marco Cacciuttolo, CEO and President of PERCIVIA, says: “This new
achievement surpasses all other reported titer levels to date with any
mammalian system and clearly demonstrates the robustness and power of the
PER.C6® platform. We are particularly enthused with the user-friendliness of
the platform and pleased to be able to provide this to our licensees. We
strive to revolutionize the pharmaceutical industry in protein production
.”
Marcel Lubben, Vice President, Marketing, Sales and Business Development at
DSM Biologics, adds: “We are extremely pleased with this achievement.
This milestone coincides with our commitment to provide the most inherently
robust manufacturing platform and ensure the utmost product quality for
protein manufacturing. Our mission of only the best quality for manufacturing
is echoed by the PER.C6® technology platform.”
“The PER.C6® Manufacturing Platform once again demonstrates itself as
the most robust commercial system available today combining ease of use, and
plug and play essentials, for any standard equipment, with little optimization
requirements” states Martina Molsbergen, VP Business Development PER.C6®
Licensing, Crucell. “Companies are rapidly embracing the PER.C6®
technology as the true commercially viable tool for protein manufacturing.
More so, the COGS savings to be realized for companies employing the PER.C6®
platform are compelling enough to offset risks in drug development.”
About PER.C6® Technology
Crucell's PER.C6® technology
platform has been developed for the large-scale manufacture of
biopharmaceutical products such as recombinant proteins including monoclonal
antibodies. Compared to conventional production technologies, the strengths of
PER.C6® technology lie in its excellent safety profile, scalability and
productivity under serum-free culture conditions.
About XD™ Technology
DSM’s XD™ technology has been
developed as a proprietary system to drive yield improvements in mammalian
systems. “XD” stands for extreme density, as the process is able to push the
cell density within the bioreactor to maximum productivity.
About PERCIVIA
PERCIVIA PER.C6® Development Center, a joint
venture between DSM and Crucell, develops the PER.C6® human cell line for the
expression of recombinant proteins. PERCIVIA provides solutions for protein
production to licensees of PER.C6® technology. PERCIVIA houses dedicated staff
working in state-of-the-art laboratories with sufficient space to afford
PER.C6® users a hands-on experience of our technology.
About Crucell
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss
Exchange: CRX) is a global biopharma company focused on research, development,
production and marketing of vaccines, proteins and antibodies that prevent and
treat primarily infectious diseases. Its vaccines are sold in public and
private markets worldwide. Crucell's core portfolio includes a vaccine against
hepatitis B, a fully-liquid vaccine against five important childhood diseases
and a virosome-adjuvanted vaccine against influenza. Crucell also markets
travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera
vaccine and the only aluminum-free hepatitis A vaccine on the market. The
Company has a broad development pipeline, with several product candidates
based on its unique PER.C6® production technology. The Company licenses its
PER.C6® technology and other technologies to the biopharmaceutical industry.
Important partners and licensees include DSM Biologics, sanofi-aventis,
Novartis, Wyeth and Merck & Co. Crucell is headquartered in Leiden, the
Netherlands, with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and
the US. The Company employs over a 1000 people. For more information, please
visit www.crucell.com.
About DSM Biologics
DSM Biologics, a business unit of DSM
Pharmaceutical Products, is a global provider of manufacturing technology &
services to the biopharmaceutical industry. In addition to offering
world-class biopharmaceutical manufacturing services, DSM Biologics has
co-exclusive rights, along with Dutch biotech company Crucell N.V., to license
the high-producing PER.C6® human cell line as a production platform for
recombinant proteins and monoclonal antibodies. The combination of the PER.C6®
human cell line and DSM’s manufacturing services provides companies with a
turn-key biologic manufacturing solution reducing cost, risk and time to
market.
