DSM Celebrates Opening of New cGMP Facility
The facility was built in partnership with Biopharmaceuticals Australia with cooperation from the government of Queensland and the Commonwealth of Australia. This world-class operation in the Asia-Pacific region is an important growth area in DSM’s strategic development in the biopharmaceutical field.
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.