Feature

BPA

australasia

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Australasia Outlook learns how BioPharmaceuticals

Australia (BPA) is playing a key role in

helping Queensland to develop the medicines of

the future.

By Ian Armitage

Making the

of the future

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BioPharmaceuticals australia

Focus ManufacturingThe Australian government has identified the

biopharmaceutical industry as key to the country’s future but at present an estimated A$15-30 million goes offshore every year to contract manufacturers of biologic drugs and

bio therapeutic compounds in clinical development. Brisbane’s A$354 million Translational Research

Institute (TRI) will play “a significant role” in turning that around.

Once built, it will be home to Australia’s first major contract manufacturing facility for biologic drugs and therapeutics.

“The GMP facility is being built by BioPharmaceuticals Australia (BPA) and will be co-located with the Translational Research Institute on the Princess Alexandria Hospital campus in Brisbane,” says David Hughes, CEO of BPA. “The project’s origins go back to 2005 when the Queensland Government provided A$7 million seed funding for the facility under its 10-year Biotechnology Strategic Plan. The Commonwealth is also directly investing A$10 million, as part of its ongoing push to win high-tech, high-value jobs and industries for Australia and it will fill a huge gap in our biotechnology infrastructure.“

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BioPharmaceuticals australia

The TRI will be one of the few places in the world that can turn research discoveries into real-world treatments for patients. This, Hughes says, is a turning point in the development of Queensland’s biotechnology industry.”

“The Queensland Government’s Queensland biotechnology strategic plan 2005-2015: biotechnology-setting new horizons outlines measures to assist the industry reach its projected growth of achieving A$4 billion in revenues and employing over 16,000 Queenslanders in an industry worth A$20 billion by 2025. What our facility will do is allow local companies to make the relatively small quantities of biopharmaceuticals needed for early-stage clinical trials, as well as scale-up their processes and take them right through to market. That is significant. This is a game-changer here locally. We will give home-grown companies the tools they need to compete, enabling Australia to reap the downstream value of its biomedical discoveries and deliver more revolutionary drugs to the world. The Australian biotech industry is rapidly growing. This is an exciting time.”

BPA’s state-of-the art facility will house cutting-edge technologies for manufacture of biological drugs

DSM Biologics has entered into a partnership with BioPharmaceutical Australia with funding provided by the Federal Government and the Government of Queensland. A primary purpose of the collaboration is to provide local services to Australian biopharmaceutical companies. Australian biopharmaceutical developers will be able to locally manufacture new drug candidates to international standards in preclinical, clinical and commercial phases. This is an important step for the Australian industry.

The DSM offering will be an important continuation and expansion of the services we currently provide from our facility in Groningen, The Netherlands. Clients will have the added advantage of being able to choose between standard technology processes or DSM’s proprietary XD® and DSP optimization technologies.

The facility is being built in Brisbane within the new Queensland Translational Research Institute, a one-stop-shop for discovery, production, clinical testing and manufacturing of new biopharmaceuticals.

DSM will bring its know-how to Australia to the benefit of the local industry. DSM has 25 years of experiences in transferring modern technologies and know-how to other locations inside and outside of the Netherlands.

DSM Biologics

DSM brings 25 years of experience in Mammalian cGMP Manufacturing to Australia

DSM Biologics Suite 2, 154 Ipswich Road

Woolloongabba, QLD 4102AustraliaT: +61 (0)7 3171 3180 E: info.dsmbiologics@dsm.com W: www.dsmbiologics.com

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Biopharmaceuticals are produced in live cells - from bacteria, plants and animals - especially mammalian cells, which most resemble human metabolism - Hughes says, and drugs of this kind are being developed for hard-to-treat conditions such as dementia, Parkinson’s and cancer.

“They are typically proteins produced by living organisms that have uses as therapeutics or in vivo diagnostics,” he explains. “We have high hopes for the biotechnology revolution which has already been a major factor in creating a large number of new biotechnology drugs and rapid advances in screening technologies. The result is that there are many more drug prospects being produced and evaluated than ever before, and there has been a move toward rationally designed biological drugs -compared to the traditional synthetic chemistry-based small molecules that are more hit-and-miss in terms of efficacy. Many major pharmaceutical companies are moving towards biotechnology and biopharmaceutical development.”

The BPA’s facility will open in mid-2013 and will be will be operated by international drugs contract manufacturer DSM Biologics.

“I have to stress how significant this is – it will enable local companies to manufacture the biopharmaceuticals needed for clinical trials, assisting the TRI to turn research discoveries into treatments for patients,” Hughes says. “There will be far more manufacturing happening here and many hundreds of jobs will be created.

“Construction of the building began in 2010 and we are halfway through the internal fit-out currently. Commercial start is scheduled for mid 2013 – our target is July – and when finished it will offer mammalian cell-based process development and contract GMP clinical and commercial manufacturing services. We are very pleased to have DSM Biologics onboard.”

DSM will provide limited up-front capital but will “come with technological expertise to design and set up the facility” and will employ its “proprietary tech when operating” it, Hughes says. “Why

BioPharmaceuticals australia

Mammalian cell culture in DSMB’s existing plant in the Netherlands; the BPA plant will be larger again.

Construction of the facility is well underway, co-located with the Translational Research Institute (left).

Focus Manufacturing

them? Good question! Well, DSM is the ideal partner for this important initiative. We were impressed with the experience, expertise and technologies of DSM. Their vision matches ours and Australia’s first facility of this kind will have state-of-the-art capabilities. Australian biopharmaceutical developers will be able to locally manufacture new drug candidates to international standards in preclinical, clinical and commercial phases. This is an important step for our industry and it is very, very exciting.”

The biotechnology industry in Australia is rapidly growing with over 400 companies currently engaged in development activities. The future is certainly bright.

“It is the first major Australia-based mammalian biopharmaceutical manufacturing facility,” Hughes, who has considerable technical and commercial experience in the scale-up and commercialisation of biotech products, concludes. “All the new block-buster drugs - A$1 billion sales per annum from launch - tend to be biopharmaceuticals and it is easy to see why this facility will play an important part in Australia’s manufacturing future.

“During the past two decades, biopharmaceuticals have emerged as a major and fast-growing product class in the pharmaceutical industry. This will make Australia an even more attractive destination for investment in biopharmaceutical research, development, and production. Queensland is home to first-class providers of the full range of complementary services needed by young biotech firms, such as regulatory affairs, pre-clinical testing, and setting-up and conducting clinical trials in patients.”

For the domestic industry to thrive, Australia needs to attract and retain multinational companies’ operations on its shores. This facility will go a long way in achieving that goal while helping local players develop niche high quality and knowledge-intensive products that are difficult to replicate.

To learn more visit www.biopharmaus.com.au.

“During the past two decades, biopharmaceuticals have emerged as a major and fast-growing product class in the pharmaceutical industry. This will make Australia an even more attractive destination for investment in biopharmaceutical research, development, and production”

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BioPharmaceuticals australia

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