DSM plans July opening for Australian biopharma facility
pharmafile | April 23, 2013 | News story | Manufacturing and Production |Â Â CMO, DSMÂ
Contract manufacturing organisation DSM Pharmaceutical Products is planning to officially open a new biopharma plant in Australia in July as part of a push into the Asia-Pacific region.
The Brisbane facility is DSM’s flagship commercial-scale biologics plant and will operate alongside the CMO’s existing R&D and manufacturing site in Groningen, the Netherlands. It has been set up with financial assistance from Queensland State Government and the Commonwealth of Australia, and collaboration with trade body BioPharmaceuticals Australia (BPA).
The diminutive 8,000 sq. m. plant will start operation with an output capability of 500kg worthy of a much larger facility, and with scope for additional capacity expansion in future. Process development services are already online, having started up towards the end of 2012.
It also makes extensive use of disposable, single-use manufacturing technologies which reduce the risk of cross-contamination and bioburden issues whilst reducing capital and operating costs, and has been designed in compliance with strict Australian legislation on environmentally-friendly construction practices.
“This operation combines DSM’s 25 years of experience and high quality track record in mammalian cell culture manufacturing, with a state-of-the-art commercial and development facility,” commented Karen King, president of DSM Biologics, a division of DSM Pharmaceutical Products.
DSM said that Australia has a vibrant biotechnology industry, but until now has had no custom mammalian-based biopharmaceutical manufacturing operation in country. The new unit will service not only the local biotech community but also the wider Asia-Pacific region and other regions of the world, according to David Hughes, BPA’s chief executive.
The Brisbane facility already has customers on board, including local biotech company Paranta Biosciences whose lead product recombinant human follistatin – a candidate drug for inflammatory and fibrotic respiratory diseases – will be made at the plant.
Most recently, DSM announced a contract with US company DecImmune Therapeutics that will include initial development of a monoclonal antibody product for treating heart attacks at Groningen, with a transfer to Brisbane anticipated once the project reaches the clinical trial materials stage.
Phil Taylor
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