DSM Biologics Announces Yield Boosts of 5-10 Fold With XD(R) Technology for Mammalian Manufacturing Platforms

PARSIPPANY, N.J., May 18 /PRNewswire/ -- DSM announced today that its proprietary XD(R) Technology boosts bioreactor productivity and titers of mammalian cell culture processes by 5-10 fold for the production of proteins and antibodies.

Recent studies completed at the R&D labs of DSM Biologics in Groningen, The Netherlands demonstrated that the yields from CHO-based cell cultures can be increased 5-10 fold over their previous fed-batch processes using only off the shelf, commercially available media. The XD(R) Technology has been tested for antibody and recombinant protein production across multiple cell lines, and the increase was realized in all cases.

By dramatically increasing the cell density of a culture, the XD(R) Technology offers the opportunity to substantially increase titers in a very short time without changing the cell line or process media. This can economically save a project already advanced in clinical development and prevent loss of time.

Jaap Schilder, Site Director Groningen, comments, “This opens the door to a completely novel way of supplying drug substance for clinical trials and for market needs. The XD(R) process increases the overall output of a facility dramatically and the process duration and handling is similar to any fed-batch process. Development spending, time to market and cost of goods will all be significantly reduced by applying this technology. Now, up to several kilograms of drug substance can be manufactured in a single batch from small disposable bioreactors.”

Karen King, President at DSM Biologics, adds, “Our XD(R) Technology offers a substantial increase in titers and reactor output and has the potential to increase product quality as the producer cells are maintained at extremely high viability throughout the entire process. Clients can use the XD(R) Technology within their existing infrastructure or it can be the basis of an optimized new plant design offering costs-of-goods advantages and reductions in capital expenditure.”

DSM is currently working with multiple customers at the Groningen site for XD(R) process development. They are booking development slots now for the remainder of 2009 and 2010.

DSM Pharmaceutical Products

DSM Pharmaceutical Products is a global provider of high quality custom contract manufacturing and development services to the pharmaceutical and biopharmaceutical industries. DSM contract manufacturing services include: chemical development, registered intermediates, registered starting materials, active pharmaceutical ingredients (API’s), fermentation, mammalian cell production of monoclonal antibodies and proteins, formulation development, clinical trial manufacturing and finished dose form manufacturing of solids, semi-solids, and scheduled drugs, aseptic liquid and lyophilized products. More information: www.dsmpharmaceuticals.com.

About DSM Biologics

DSM Biologics, a business unit of DSM Pharmaceutical Products, is a global provider of manufacturing technology and 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.

About XD(R) Technology

XD(R) Technology has been developed for use with mammalian cell lines. “XD” stands for extreme density, as this process is able to push the cell density within the bioreactor to maximum productivity using readily available equipment.

DSM - the Life Sciences and Materials Sciences Company

Royal DSM N.V. 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, electrical and electronics, life protection and housing. DSM has annual net sales of EUR 9.3 billion and employs some 23,500 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam. More information: www.dsm.com.

DSM 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 information currently available. The statements involve certain risks and uncertainties that are difficult to predict and therefore DSM does not guarantee that their expectations will be realized. Furthermore, DSM has no obligation to update the statements contained in this press release.

For further information please contact:

CONTACT: Karen King, President, +1-973-257-8427, or Karen.King@dsm.com,
Jeremy Caudill, Vice President, Marketing, Sales & NBD, +1-973-257-0000, or
jeremy.caudill@dsm.com, both of DSM Biologics

Web site: http://www.dsm.com/

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