Updated on 14 June 2012
Australian commercial environment offers good IP protection, with advanced legal and financial systems
Australia has a long history in biomedical research, with a reputation for excellence and invention since the early 1900s. This history includes a notable sprinkling of Nobel Prize winners, including Howard Florey (penicillin, 1945), Macfarlane Burnett (immunology, 1960), Peter Doherty (immunology, 1996) and Barry Marshall (gastric ulcer, 2005). This tradition continues today, with record numbers of biomedical researchers active in scores of institutes.
This critical mass of researchers and institutions — all aiming to generate intellectual property relating to new medicines — has led, over decades, to the development of downstream capabilities required to take biomedical inventions to the clinic. Such capabilities include services relating to pre-clinical development, process development, regulatory compliance, and performing of clinical trials. This depth of experience around biomedical R&D and associated infrastructure creates a differentiator for Australia in a regional context, not only because of the drug pipeline generated locally, but also because of the range of the capabilities needed to service it.
An important addition to the range of biotherapeutic drug development capabilities is currently being installed in Brisbane in the form of a world-class contract manufacturing organization (CMO) targeting scale-up and commercial manufacture of biologic drugs. Biopharmaceuticals Australia (BPA), a Queensland Government-owned biopharma industry-development vehicle, has teamed up with DSM Biologics (DSMB) to design and build a new mammalian-cell culture facility dubbed the Biologics Plant Of the Future. The capital funding has been provided principally by the federal and Queensland state governments. The new plant, due to come on-line in early 2013, will add to DSMB's existing CMO capacity at their plant in Groningen, the Netherlands.
The DSMB plant will feature not only the latest in single-use disposable systems for processing activities, but also a number of proprietary high- performance technology platforms. These include the PER.C6 human cell line, use of DSMB's XD high-productivity cell culture process, the Rhobust expanded-bed adsorption technology (which cuts the number of unit operations and reduces cycle times), and new downstream processing optimization technology, the Kremer Method. These differentiating technologies all aim to add value for the client through better process control, reduced waste and higher throughput.
The BPA-facilitated development represents the latest in a string of government-supported projects over the last decade targeting gaps in the capability chain required to take biomedical inventions from bench-to-bedside. Governments in Australia have sought to leverage the strength of the fundamental research in biomedical science into the ability to translate invention into practical medicines. This has been attained by encouraging applied research, synergistic grouping of researchers and clinicians, commercially-oriented pre-commercial development, preclinical and clinical services, and by actively promoting Australia as a destination for conducting clinical trials.