DSM Biologics and Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX)
announced today that the high-titer fed-batch process developed at the
PERCIVIA PER.C6® Development Center, their joint venture in Cambridge, USA was
recently scaled up to 250 liters by DSM Biologics scientists at their GMP
facility in Groningen, The Netherlands. They successfully achieved 8 grams per
liter for an IgG expressed by PER.C6® cells using chemically defined cell
culture medium in a SUB (single-use bioreactor).
This result confirms a reliable, versatile and commercially feasible
production platform to manufacture large amounts of therapeutic proteins with
ease and economic affordability. Also, this latest result, using conventional
fed-batch process, adds to the previous achievements of 27 grams per liter –
biomass corrected – using DSM’s XD™ technology, and demonstrating a reliable
performance of the PER.C6® cell line under such production conditions.
Marco Cacciuttolo, CEO and President of PERCIVIA, comments that “This new
development further strengthens our commitment to modernize therapeutic
protein manufacturing. The successful scale up of the high titer fed-batch
process means that the PER.C6® platform can be easily and quickly implemented
into commercial facilities with no retrofit requirements. We continue to be
very pleased and enthused by the ease of use, the reproducibility, and the
overall robustness of the platform.”
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.
DSM – the Life Sciences and Materials Sciences Company
DSM creates innovative products and services in Life Sciences and Materials
Sciences that contribute to the quality of life. DSM's products and services
are used globally in a wide range of markets and applications, supporting a
healthier, more sustainable and more enjoyable way of life. End markets
include human and animal nutrition and health, personal care, pharmaceuticals,
automotive, coatings and paint, electrics and electronics, life protection and
housing. DSM has annual sales of almost EUR 8.8 billion and employs some
23,000 people worldwide. The company is headquartered in the Netherlands, with
locations on five continents. DSM is listed on Euronext Amsterdam.
Forward-looking statements
This press release contains forward-looking statements that involve
inherent risks and uncertainties. These statements are based on current
expectations, estimates and projections of the management of DSM and Crucell
and information currently available to both companies. The statements involve
certain risks and uncertainties that are difficult to predict and therefore
DSM and Crucell do not guarantee that their expectations will be realized.
Furthermore, DSM and Crucell have no obligation to update the statements
contained in this press release.
Crucell N.V. has identified certain important factors that may cause actual
results to differ materially from those contained in such forward-looking
statements. For information relating to these factors please refer to the Form
20-F, as filed by Crucell N.V. with the U.S. Securities and Exchange
Commission on May 7, 2008, and in particular the section entitled “Risk
Factors”. Crucell N.V. prepares its financial statements under International
Financial Reporting Standards (IFRS).