Why our clients are choosing to manufacture biopharmaceuticals in Australia
World-class researchers and state-of-the-art facilities, a streamlined regulatory framework, and generous tax incentives have made Australia a prime location for the biotech industry.
Over the past decade, Australia has become a global leader in life science research and biologics manufacturing. Generous tax incentives and government funding are further strengthening its position as a prime location for biotech companies.
Placed 17th in 2010, Australia has jumped to fifth (out of 54 countries) in global biotechnology, outperforming countries like the United Kingdom, Germany, and Canada.
Australia is home to more than 400 locally-owned biotechnology and 500 MedTech companies, and with around 50 multinationals operating subsidiaries in Australia, including GSK, Merck, Pfizer, Bristol-Myers Squibb, and Novartis, the Australian life sciences sector is valued at over AU$100 billion.
Global investment in the sector is currently fuelling annual growth of 4.4% with aggregate revenue is expected to reach $8.7 billion by 2021, making Australia a thriving hub for biotechs in the Asia-Pacific region.
And agreements between the Australian Therapeutic Goods Administration (TGA) and the U.S. Food and Drug Administration and European Medicines Agency are aligning Good Manufacturing Practice across the jurisdictions, paving the way for Australian-based biotech companies looking to enter U.S. and European markets.
From strength to strength
Located in Brisbane, Australia, Luina Bio is an award-winning and leading Contract Manufacturing Organisation (CMO) servicing global companies in the pharmaceutical, biotechnology, and veterinary industries.
Luina Bio’s highly skilled and experienced team provides manufacturing solutions for both biological and small molecule drugs, including master and working cell bank preparation, validation and storage, upstream fermentation, and downstream biopharmaceuticals purification.
In business for over 20 years, the company was rebranded in 2016, expanding rapidly from a dozen employees to over 60 staff, reflecting not only increased sales but also its recognition as an innovative and high-quality CMO. For instance, in 2017, it received the Queensland Export Award in the Health and Biotechnology category, was a winner in the Westpac Top 200 Companies of Tomorrow award, in 2018, and is a finalist in International Health Award category for the 2019 Queensland Export Awards.
“Advances in the development of microbiome-based therapies have been largely responsible for our growth,” explains Les Tillack, Managing Director of Luina Bio. “Over the past three years, we’ve positioned ourselves as a lead manufacturer of Live Biotherapeutic Products for biotechs and pharmaceutical companies, and the momentum doesn’t show any signs of slowing.”
Although a truly global company—over 90% of its customers are based overseas—much of Luina Bio’s success can be attributed to its location in Australia, and in particular the state of Queensland.
With world-class universities, hospitals, and research facilities, and internationally recognized capabilities in imaging techniques, biofabrication, preclinical and early phase clinical trials, and pilot to commercial-scale biopharmaceutical manufacturing, the state is becoming a prime location for world-leading CMOs.
Also, global biotechs are now recognizing the value of locating their operations close CMOs. A position supported by findings from the Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2019.
Sponsored by Luina Bio, the study surveyed opinions from pharmaceutical and biotechnology companies as well as CMOs in the United States, Europe, and Asia on pricing models and contract agreements used in the biopharmaceutical contracting market.
Around 40% of the respondents who use CMOs reported that location was important when selecting one for process development work and that locating development teams close to CMOs fostered better communication between themselves and the CMO, which aids in timely problem-solving.
Biotechs looking to invest in Queensland can also benefit from Australia’s robust intellectual property regime, ranked 7th out of 135 countries on the International Property Rights Index in 2018. With generous tax breaks and government funding helping to reduce the cost of R&D and providing support for product commercialization.
For example, the Australian Government’s R&D Tax Incentive offers companies a 43.5 % cash rebate on qualifying R&D expenditure, lowering the cost of innovation and deferring the need to raise further capital. The AU$500 million Biomedical Translation Fund provides access to venture capital funding for the development and commercialization of biomedical discoveries. And the AU$45 million BioMedTech Horizons program supports proof-of-concept to the commercial development of biomedical technologies.
A global centre-of-excellence for clinical research
The establishment of world-leading clinical trial capabilities has been vital to Australia’s biotech success story, with nearly 1,000 new clinical trials every year attracting over AU$1 billion in investments by pharmaceutical, biotechnology, and medical device companies.
A streamlined regulatory pathway also allows rapid entry for clinical trials through the Clinical Trials Notification scheme, administered by the TGA. Approvals now take as little as six weeks compared to over a year in the United States, lowering the cost for companies by up to 28% before taxes incentives, and 60% after.
“As one of the few companies of its type in Australia, we have a proven track record in the manufacture of drugs from bacterial and yeast fermentation for use in clinical trials,” explains Tillack. “Being located in Queensland provides us with the perfect platform to expand our business.”
Queensland Health, a department of the Government of Queensland, is also assisting biotechs in conducting clinical trials through a network of providers, including Novotech, Q-Pharm, and Icon Group, that support the full life cycle of industry-sponsored clinical trials.
And Life Sciences Queensland Ltd, a peak industry group representing over 170 members in Queensland, is helping developers of human therapeutics and devices to distribute preclinical and clinical research to its network of service providers. Queensland’s outstanding clinical trial capabilities, including First-in-Human and early phase clinical trials, and its ethnically diverse population assisting patient recruitment, is making the state a one-stop-shop for clinical research. Another drawcard for attracting overseas investment into the state.
For example, over two-thirds (68%) of respondents in the biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2019 cited improved project management, increased product flow, shorter time to market, decreased time for lot release, transportation, and technology transfers, and reductions in value-added taxes, as significant benefits flowing from the use one-stop-shop CMOs.
Moreover, with its proximity to some of the fastest-growing economies in the world—China, Hong Kong, Korea, Japan, and Singapore are just two time zones away—Queensland is the perfect location for companies looking to invest in the life sciences sector.
“In response to a growing customer base we are expanding our capacity with the construction of a much larger manufacturing facility, and will be operational towards the latter part of 2020,” says Tillack.
This article was first published on the Luina Bio website. Read the original article here.