Commercial production will start at the facility in January 2014
DSM Pharmaceutical Products, the contract manufacturing and technology business of Royal DSM, is expanding its biopharmaceuticals business with the official opening of its new cGMP manufacturing facility in Brisbane, Australia.
The plant was built in partnership with Biopharmaceuticals Australia with cooperation from the government of Queensland and the Commonwealth of Australia. It offers cGMP mammalian cell culture contract manufacturing services from process development through to commercial manufacturing.
'With its flexible design and use of single-use technology, the facility represents the model for the future of biomanufacturing,' said Lukas Utiger, President and CEO of DSM Pharmaceutical Products. '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 will operate the Brisbane facility in addition to offering process development and cGMP manufacturing in Groningen, The Netherlands.
DSM has already announced contracts for the Brisbane site with DecImmune Therapeutics of Cambridge, Massachusetts, US; Recepta Biopharma in São Paulo, Brazil; Paranta Biosciences of Melbourne, Australia and Opthea, which is also based in Melbourne.
The new facility has an output capability of 500kg with expansion space for further capacity utilisation. In June, the plant was assessed by inspectors from TGA (Therapeutic Goods Act) and in September it was granted a rating of A2 – satisfactory compliance with the manufacturing standard established under the Therapeutic Goods Act 1989.
DSM will now conduct process development work and make technical production runs at the plant. Commercial production will begin next January.