Bringing Effective Drug Manufacturing Solutions to Brisbane
BioPharmaceuticals Australia and DSM
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Netherlands-based global company Royal DSM, active in health, nutrition and materials, recently opened a new facility in Brisbane to manufacture biopharmaceuticals for early-stage clinical trials and commercial production. Such medicines will be used to treat severe illnesses such as inflammatory diseases, cancer and other significant diseases. It is a good example of a public and private partnership, creating value and jobs.
In an interesting series of moves, a special body was set up to first woo then work with the Dutch corporation. BioPharmaceuticals Australia (BPA) is an unlikely state entity but an effective one. It was established with the support of the Queensland government to achieve two broad objectives: first, to design, fund and construct a new GMP facility to be operated by DSM Biologics, a business unit within DSM Pharmaceutical Products; and secondly, to facilitate synergies between complementary providers of clinical development services. The state authorities have a ten-year plan to turn the region into a kind of ‘Biopharm Valley’, a hub for world-class biomedical research activity.
The facility is intended to provide Australia with a world-class manufacturing facility for biological drug developers. The BPA network will also give developers access to a range of complementary service providers to help take drugs from the developmental stages to the marketplace.
The pitch to lure DSM to Australia was made in the third quarter of 2009. Naturally the global giant was the subject of similar overtures from other countries and David Hughes, Chief Executive of BPA, acknowledges that quite a lot of investment has gone into ensuring DSM landed in Brisbane, instead of choosing one of several alternative locations for its Asia-Pacific push. Of the $65 million budget, some $10 million came from a one-off federal grant (in recognition that Australia needs to beef up its ability to commercialise what is already world-leading research in the field) and $7 million-plus came from the Queensland government.
Much of the remainder came via the Translational Research Institute, a joint venture between the University of Queensland Diamantina Institute, Queensland University of Technology’s Institute of Health and Biomedical Innovation, Mater Medical Research Institute and the Princess Alexandra Hospital’s Centres for Health Research. The TRI was made possible through $354 million in funding provided by the Australian and Queensland Governments, The Atlantic Philanthropies, UQ and QUT. It is led by Professor Ian Frazer, Australian of the Year 2006 and co-inventor of the cervical cancer vaccine.
Officially, DSM is BPA’s partner in the enterprise, as the two entities have worked together to realise the facility, of which BPA is DSM’s ‘landlord’ on an initial ten-year lease with a variety of options for the future. However, as a not-for-profit organisation, BPA’s primary mission is to assist transforming the local industry. David explains that they took the lead as a kind of project manager, with responsibility for all aspects – consultants, architects, engineers and more – as well as the funding.
BPA’s secondary mission is to implement ideas, over the next three years or so, to promote the centre that DSM operates, and to help develop a network of related service providers who will complement DSM’s offering – such as companies designing and performing clinical trials, or consultants to provide regulatory advice and liaising with the US FDA on behalf of customers. “Many such companies operate in and around Brisbane,” says David, “and we saw an opportunity to add up the individual companies and come up with something greater than the sum of the parts.” The idea is to encourage interstate and international drug companies to use these service providers, developing the regional cluster effect the likes of which are already working in places like North Carolina in the US.
“We think we have some advantages in the early clinical development space by virtue of Australia’s long history of clinical development and its 150 years of medical research,” David shares. “That has distinguished us from Southeast Asia and created an industry around early-stage drug development.”
The state – and the country as a whole – is not going to benefit much from the conventional business of churning out millions of pills; that is not what DSM or BPA are about. “But around the earlier stages – developing new drug products – is where we do have some competitive advantage,” says David. Early signs from Canberra are that the new administration views the opportunities essentially the same way as the previous government, so David is optimistic no changes will be demanded, especially with 50 skilled positions already created by the project.
And that is not all. Australia has, crucially, an extremely well respected regulatory framework and decent controls and security for intellectual property. Both of these are vital not only to DSM but also to its prospective clients – and all major pharmaceutical companies worldwide. Companies in places like the UK and the US are already expressing close interest in using the new Brisbane GMP facility; there is an aspect of credibility here that is lacking by comparison in other areas. There is a tax incentive here for companies on their R&D costs, of course, which includes clinical research and softens the bill as far as our expensive labour is concerned.
Yet another plus-factor for Australia is the way it streamlines clinical trials, with an efficient and effective way of getting products into clinical trials compared to the rest of the world in the form of the CTN (clinical trial notification) scheme. In essence, this enables researchers to use their new formulations on real human patients (with all the appropriate safeguards, of course) in a unique accelerated approval process.
Tertia Dex is Business Development Director of DSM’s Australian operation, and she confirms the value of the credibility in this country, admitting it would be much more difficult to attract customers to other Asia-Pacific locations such as India and China, pretty important given that the development is part of DSM’s overall strategy to grow substantially in the region. Despite the relatively high cost of biopharmaceutical development, DSM is working to try to drive down the cost of these medicines and allay the fears of the public regarding so-called ‘Big Pharma’.
In its first phase, the new facility (which was officially unveiled during the AusBiotech convention in October but has been operating since June) has a capacity of producing 500kilograms of drugs per year; a second phase is planned and will entail use of an as-yet-unfitted floor of the purpose-built building to double that to one tonne of biopharmaceutical drugs, a commercial-scale quantity for a top-selling drug.
So it is heartening to hear that DSM, like many other Netherlands companies, has a dedication to trying to make these new medicines more widely available and to drive down the cost of their production. “We are very socially responsible and want to be part of the solution to healthcare, not just adding to the commercial and financial potential,” says Tertia. “It’s an ethos that comes down right from the top of Royal DSM.” DSM Biologics has a number of special niche technologies that set it apart from the competition; these make the plant more efficient and drive down the cost of production compared with conventional processes. “They enable us to operate on a smaller scale while maintaining our commercial-scale output.”
One of these technologies is the XD (eXtreme Density) process which can greatly increase the cell density within the bioreactor to achieve elevated productivity. XD’s ultra-high yields allow for downsizing of bioreactors and open new avenues for biopharmaceutical manufacturing. The process offers a 5 to 25-fold increase in process yield compared to standard fed-batch processes, which translates expression to up to 12 g/L for recombinant proteins or 27 g/L for IgG products independent of the cell line. “This technology is widely applicable to almost all biopharmaceutical products,” adds Tertia. “This is a world-leading process and it significantly lowers the cost of making the goods.”
With savings being passed on to DSM’s customers – and assuming they in turn pass the savings on to the end users – healthcare providers in Australia, as well as in many other regional markets, will have much to thank in the vision of the federal and state authorities to green-light this unusual partnership.
