DSM Biologics Announces Milestone Advancement of Yield-Boosting XD(R) Technology for Biomanufacturing

PARSIPPANY, N.J., May 5 /PRNewswire/ -- DSM Biologics, a business unit of DSM Pharmaceutical Products, announced today advancement in its technology portfolio: a successful scale up of its proprietary, yield-boosting XD® technology from 2L to 50L using a CHO cell line. Rolf Douwenga, Vice President, Global Technology was quoted as saying: "We are excited about the robustness of the scale-up to 50L scale.  The data proves again that the XD® technology is very consistent in scalability independent of the cell lines or types of recombinant proteins we have tested."

By dramatically increasing the cell density and optimizing the conditions for protein production of a culture, DSM's proprietary XD® Technology offers a simple, elegant solution to substantially increase titers without changing the cell line or process media.  The scale up runs at DSM demonstrated record viable cell densities up to 170 million cells/ml.  Record titer improvements of 5-10 fold over standard fed-batch and perfusion processes have been consistently achieved in multiple mammalian cell systems including CHO and PER.C6. The technology has broad applicability and benefits to mammalian cell systems and across various target production molecules including monoclonal antibodies and recombinant proteins.  

This improved performance has been achieved using off-the-shelf, chemically-defined media within a two week culture.  Progress is underway for scale-up to the next level with results anticipated later in 2010.  Jeremy Caudill, Vice President, Sales and Business Development stated: "The results from DSM's proprietary XD® technology demonstrate a paradigm shift in biologics drug manufacturing.  Companies can now substantially shrink their bioreactor size requirements by 5-10 fold, reducing the CAPEX required for building a new plant and ultimately reducing overall cost of goods."  

About DSM Biologics and XD® Technology

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 the offering of world-class biopharmaceutical manufacturing services, DSM Biologics provides and develops technologies relevant for optimized mammalian cell culture processes. Examples are the proprietary XD® Technology for use with mammalian cell lines. The "XD process" leads to very high cell densities within the bioreactor, which result in maximum productivity using readily available equipment.  DSM's manufacturing services provides companies with a turn-key biologic manufacturing solution reducing cost, risk and time to market.  More information: www.dsmbiologics.com

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.

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), 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.dsmpharmaceuticalproducts.com

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 7.7 billion and employs some 22,738 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

XD® is a registered trademark of DSM N.V.

PER.C6® is a registered trademark of Crucell Holland N.V.

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.

SOURCE DSM Biologics