DSM announced today that its proprietary XD® 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® 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® 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® 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® 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®
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®
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® 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.
About XD® Technology
XD® 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.