PARSIPPANY, N.J., May 3 DSM Biologics is pleased to announce the signing of preliminary agreements to enter a partnership with the Australian Governments (Queensland State Government and the Commonwealth of Australia) to design, build and operate the first major Australia-based mammalian biopharmaceutical manufacturing facility, which will be located in Brisbane.
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The over 70,000 square foot facility will offer mammalian process development and cGMP clinical and commercial manufacturing services. DSM Biologics will employ its global expertise and portfolio of proprietary technologies to offer Australia and clients from all over the world, state-of-the-art, world-class contract manufacturing services.
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Karen King, President of DSM Biologics comments, "We are extremely honored to be selected by and partnering with the Australian Governments, in particular with the Queensland State and the Commonwealth Governments to bring Australia its first major cGMP mammalian contract manufacturing organization (CMO). This offering will be an important continuation and expansion of the services we currently provide out of our facility in Groningen, The Netherlands. Clients will have the added advantage of being able to choose between standard technology processes or Royal DSM's proprietary XD® and DSP optimization technologies." The services offered at the site will support all mammalian cell lines and process technologies including standard CHO-based systems and the PER.C6® cell-line technology, to which DSM has co-exclusive licensing rights for proteins and mAbs, together with the Dutch biotech company Crucell."
The Australian Governments (Queensland State Government and the Commonwealth of Australia) will provide the full financial funding for the facility which is part of the Queensland 10 year Biotechnology Strategic Plan. DSM will provide no capital but will provide technological expertise to design and set up the facilities and will employ its proprietary technologies in its operation.
The biotechnology industry in Australia is rapidly growing with over 400 companies currently engaged in development activities and an estimated A$ 60 million in annual CMO activity fees being exported out of the country due to the lack of a local CMO.
The new biologics manufacturing facility is anticipated to be commissioned and operational in 2013. The facility is being built in Brisbane within the Queensland new Translational Research Institute, a one-stop-shop for discovery, production, clinical testing and manufacturing of new biopharmaceuticals. BioPharmaceuticals Australia (BPA) is responsible for the overall initiative on behalf of the Queensland Government and has selected DSM Biologics to operate the facility. David Hughes, CEO of Biopharmaceutical Australia said, "Royal DSM is the ideal partner for this important initiative. We were impressed with the experience, expertise and technologies of DSM Biologics. Their vision of the 'Biologics Plant of the Future' matches ours and Australia's first facility will have state-of-the-art capabilities. Australian biopharmaceutical developers will be able to locally manufacture new drug candidates to international standards in preclinical, clinical and commercial phases. This is an important step for our industry."
DSM Biologics is a business unit of DSM Pharmaceutical Products (DPP), a global business providing cGMP custom manufacturing services across all facets of the pharmaceutical industry including small molecule API and intermediates manufacturing, fill/finish of parenteral and solid dosage forms, and large molecule drug substance production and associated technologies. Bob Hartmayer, CEO of DPP said, "We see the addition of the Brisbane facility as an important element in our DPP strategy. DPP is committed to providing our clients world-class custom services around the globe. Biologics is an important growth segment of the pharma industry and DSMB will now be positioned to serve its clients at all phases of development and commercialization. We are particularly pleased to be developing and operating the facility in partnership with the Australian Governments (in particular the Queensland State and the Commonwealth Governments)."
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.
For more information: DSM Biologics DSM Pharmaceutical Products Karen King Guy Tiene +1 973 257 8220 +1 973 257 8160 [email protected] [email protected]
SOURCE DSM Biologics
