DSM Celebrates Opening of New cGMP Facility for Biopharmaceutical Manufacturing in Brisbane, Australia
The facility was designed by an expert international team of biological scientists and bioengineers, utilizing DSM's twenty seven years of experience in mammalian cell culture processing to construct a purpose-built, state-of-the-art biomanufacturing facility. The Brisbane facility offers cGMP mammalian cell culture contract manufacturing services from process development through to commercial manufacturing. Lukas Utiger, President and CEO, DSM Pharmaceutical Products, stated, "With its flexible design and use of single-use technology, the facility represents the model for the future of biomanufacturing. It represents an important milestone in the development of Australia-based mammalian cell-based manufacturing of biopharmaceuticals, and extends DSM's contribution to the global biotechnology market."
DSM Biologics, the business unit of DSM Pharmaceutical Products that operates the Brisbane facility, also offers process development and cGMP manufacturing in Groningen, The Netherlands; together with the Brisbane site now servicing customers in all clinical stages from preclinical through Phase 3 and commercial manufacturing. DSM previously announced contracts for the Brisbane site with DecImmune Therapeutics of Cambridge, Massachusetts, USA; RECEPTA Biopharma in São Paulo, Brazil; Paranta Biosciences of Melbourne, Australia and, today, with Opthea Pty Ltd of Melbourne, Australia.
The Brisbane facility has an output capability of 500kg and has expansion space available for further capacity utilization. In June of this year the Brisbane site was thoroughly assessed by inspectors from TGA (Therapeutic Goods Act). "On September 4th, the site was granted a rating of 'A2, satisfactory compliance with the manufacturing standard established under the Therapeutic Goods Act 1989'. With the October opening DSM will conduct process development work, and make technical production runs. With a TGA manufacturing license cGMP commercial production will begin in January 2014." commented Manja Bouman, President of DSM Biologics.
The Brisbane facility is DSM's blueprint for its 'biologics plant of the future' for the production of biopharmaceuticals. As well as all industry-standard technologies, DSM also has its own innovative proprietary technologies: XD® process technology and Rhobust® direct capture technology, for the optimization of therapeutic biopharmaceutical manufacturing that drive down cost, processing times and capital requirements to meet market demand for developing affordable lifesaving medications. XD® is DSM's proprietary cell culture technology with product output 5-25 times higher compared to the current standard biomanufacturing processes. It produces very high cell densities while retaining high cell viability and consistent product quality. Rhobust® is DSM's proprietary direct capture downstream technology which combines clarification and product capture into one single step.
XD® and Rhobust® are registered trademarks of Royal DSM
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. The English language version of the press release is leading.
DSM Food Specialties Germany GmbH
Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM's 23,500 employees deliver annual net sales of around €9 billion. The company is listed on NYSE Euronext. More information can be found at www.dsmbiologics.com and www.dsm.com.
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