Royal DSM N.V. and Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX),
today announce fermentation yields of more than 10 grams per liter for
monoclonal antibodies, a major breakthrough in the development of their PER.C6
technology platform. Early last year, DSM and Crucell announced their major
objectives for their PER.C6 development joint venture. A key objective was to
achieve yields of more than 10 grams per liter for monoclonal antibodies using
the PER.C6 technology platform. Today they announced that this remarkable
milestone has been achieved within one year of setting the target.
This result was achieved by combining DSM’s considerable expertise in all
aspects of fermentation science and technology with Crucell’s
industry-recognized PER.C6® human cell line. The partners believe that in the
foreseeable future even 20 grams per liter can be realized. Looking into the
future, both partners believe that they are very well positioned to exploit
the full potential of this technology through the newly opened PERCIVIA
PER.C6® Development Center in Cambridge, Mass, USA.
Yields in the range of 10 to 20g/L are an order of magnitude higher than
current industry averages. The higher yields allow the use of much smaller
bioreactors and opens routes to significantly lower cost of goods for
biopharmaceuticals.
Ronald Brus, CEO of Crucell is delighted
with the results: “We have always had confidence in the huge
potential of PER.C6, and these results are only the beginning. This is a major
breakthrough in reducing the cost of goods in biopharmaceutical production
.”
Leendert Staal, CEO of DSM Pharmaceutical Products comments: “This is
an outstanding achievement of our organization in Groningen, which will have a
major impact on the way we will produce in the future. We believe that these
results mark the beginning of a paradigm shift in the industry.”
Pieter de Geus, Vice President Research and Development of DSM Pharmaceutical
Products, and Jaap Goudsmit, Chief Scientific Officer of Crucell are unanimous
in their assessment of the commercial potential of the results. The next steps
will be scale-up to pilot scale and ultimately commercial scale reactors.
Since December 2002, DSM Biologics and Crucell are jointly outlicensing the
PER.C6® human cell line technology to third parties as a production platform
for monoclonal antibodies and recombinant proteins. The partners recently
established the PERCIVIA PER.C6® Development Center in Cambridge, Mass, USA as
a joint venture to further develop the PER.C6® cell line and provide unique
solution for the production of pharmaceutical proteins to licensees utilizing
the PER.C6® human cell line in the biotech industry.
About the PER.C6® technology platform
Crucell's and DSM’s
PER.C6® technology platform has been developed for the large-scale manufacture
of biopharmaceutical products including vaccines. Compared to conventional
production technologies, the strengths of the PER.C6® technology lie in its
excellent safety profile, scalability and productivity under serum-free
culture conditions.
About PERCIVIA
PERCIVIA PER.C6® Development Center LLC is a
joint venture between DSM and Crucell. The Center has approximately 47,000
square feet of laboratory space in Cambridge, Mass, and will have a staff of
50 highly skilled people engaged in the development and optimization of the
human PER.C6® cells as an expression platform for proteins and monoclonal
antibodies for therapeutic use. This center of excellence will provide a fully
integrated technology platform, and true unique solutions for the production
of pharmaceutical proteins, to the biotech industry and the scientific
community. This PER.C6® 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.
About Crucell
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss
Exchange: CRX) is a biotechnology company focused on research, development and
worldwide marketing of vaccines and antibodies that prevent and treat
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 Crucell products based on its
unique PER.C6® production technology. The Company licenses this and other
technologies to the biopharmaceutical industry. Important partners and
licensees include DSM Biologics, sanofi aventis, GSK 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.