DSM Biologics Reports a New Record Achievement with DSM's Proprietary XD® Process Technology with a CHO Cell Line Producing an Fc-fusion Protein:
DSM Biologics, a business unit of DSM Pharmaceutical Products, today announced the most recent results of its XD® process technology used in producing an Fc-fusion protein in a CHO cell line as follows:
- Record viable cell density of 242 million cells/ml at day 15
- Record titer achievement for a Fc-fusion protein of 11.5g/L (corrected for biomass), compared to a 1.2g/L titer in standard fed-batch processing, a 10X titer boost
PARSIPPANY, N.J., Feb. 9, 2011 /PRNewswire/ -- The achievement was reached using fully chemically-defined media and the CHO cells maintained very high viability throughout the process with 96% viability at day 16.
Rolf Douwenga, Vice President of Global R&D for DSM Biologics said, "Our customers continue to be impressed with the consistent achievements of our XD® process technology in boosting cell titers independent of the cell line or molecule targeted. The XD® process technology is a platform approach to dramatically improve bioreactor output for mammalian cell culture. When used in combination with DSM's proprietary Rhobust™ capture and clarification technology, biopharmaceuticals can be processed at greatly reduced costs when compared to standard upstream and downstream technologies."
Viable cell densities in fed-batch are typically in the range of 10 – 20 mln cells/ml. The XD® process creates an optimal environment for the cells, by which the viable cell density can be increased to 150 mln cells/ml and higher. These very high concentrations of viable/producing cells result in a strong increase in titer. Titers for Fc-fusion proteins in fed-batch culture are typically below 1.5 g/l. The XD® process achieved a titer of 11.5 g/l, increasing titer by a factor of 10. The processes with high cell-densities can then be clarified and captured with DSM's proprietary Rhobust™ technology.
DSM Biologics has previously reported scalability of the XD® process, demonstrating consistent results in scaling the process from 2L to 50L in its cGMP manufacturing facility in Groningen in The Netherlands. Scale-up runs demonstrating viable cell densities up to 170 million cells/ml, and 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, hybridoma and human cell lines. The technology has broad applicability and benefits to mammalian cell systems across various target production molecules including monoclonal antibodies and recombinant proteins.
XD® is a registered trademark of DSM
Rhobust™ is a trademark of DSM
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 offering 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 vey high cell densities within the bioreactor, which result in maximum productivity using readily available equipment. DSM's manufacturing services provide companies with turn-key biologic manufacturing solutions reducing cost, risk and time to market. More information: www.dsmbiologics.com
The Rhobust™ technology is the next generation expanded bed chromatography (EBA), using cross linked agarose beads with Tungsten Carbide to increase the particle density. Rhobust™ is applied as direct capture step for mammalian and microbial harvest to increase yields, reduce the number of unit operations and reduce process cost. Different patent families around the world have been established.
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 solutions that nourish, protect and improve performance. Its end markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrical and electronics, life protection and housing. DSM manages its business with a focus on the triple bottom line of economic performance, environmental quality and social responsibility, which it pursues simultaneously and in parallel. DSM has annual net sales of about euro 8 billion and employs some 22,700 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
This press release may contain forward-looking statements with respect to DSM's future (financial) performance and position. Such statements are based on current expectations, estimates and projections of DSM and information currently available to the company. DSM cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. DSM has no obligation to update the statements contained in this press release, unless required by law.
SOURCE DSM Pharmaceutical Products