29 October 2013

DSM Opens New cGMP Facility for Biopharmaceutical Manufacturing in Brisbane, Australia

Parsippany, N.J. - 29 October 2013 - DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, has officially opens its new cGMP facility for biopharmaceutical contract manufacturing in Brisbane, Australia. The facility was built in partnership with Biopharmaceuticals Australia with cooperation from the government of Queensland and the Commonwealth of 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.

Royal DSM is a global science-based company active in health, nutrition and materials. DSM's 23,500 employees deliver annual net sales of around €9 billion. The company is listed on NYSE Euronext.

Source: DSM Pharmaceutical Products / PRNewswire