GRONINGEN and LEIDEN, Netherlands and PARSIPPANY, N.J., Sept. 29 /PRNewswire/ -- DSM Biologics and Crucell N.V. announced today that the high-titer fed-batch process developed at the PERCIVIA PER.C6(R) 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(R) 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(TM) technology, and demonstrating a reliable performance of the PER.C6(R) 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(R) 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(R) Technology
Crucell’s PER.C6(R) 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(R) technology lie in its excellent safety profile, scalability and productivity under serum-free culture conditions.
About XD(TM) technology
DSM’s XD(TM) 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(R) Development Center, a joint venture between DSM and Crucell, develops the PER.C6(R) human cell line for the expression of recombinant proteins. PERCIVIA provides solutions for protein production to licensees of PER.C6(R) technology. PERCIVIA houses dedicated staff working in state-of-the-art laboratories with sufficient space to afford PER.C6(R) users a hands-on experience of our technology.
About Crucell
Crucell N.V. 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(R) production technology. The Company licenses its PER.C6(R) 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(R) human cell line as a production platform for recombinant proteins and monoclonal antibodies. The combination of the PER.C6(R) 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).
For further information please contact:
DSM Pharmaceutical Products
Karen King
President
DSM Biologics
Tel: +1-973-257-8427
Karen.King@dsm.com
DSM Biologics
Marcel Lubben
Vice President
Marketing, Sales & NBD
Tel: +31-(0)46-477 3343
marcel-m.lubben@dsm.com
Crucell N.V.
Oya Yavuz
Director Corporate Communications & Investor Relations
Tel: +31-(0)71-519 7064
ir@crucell.com
CONTACT: Karen King, President of DSM Biologics for DSM Pharmaceutical
Products, +1-973-257-8427, Karen.King@dsm.com; or Marcel Lubben, Vice
President, Marketing, Sales & NBD for DSM Biologics, +31-46-477 3343,
marcel-m.lubben@dsm.com; or Oya Yavuz, Director Corporate Communications &
Investor Relations for Crucell N.V., +31-71-519 7064, ir@crucell.com
Web site: http://www.crucell.com/
http://www.dsm.com/
