Making modern medicines in Australia

Australia’s medical manufacturing industry is setting global standards for innovation and quality. Astra Zeneca, CSL, GlaxoSmithKline, Merck, Novartis and Pfizer are among the many global pharmaceutical giants that have engaged Australian contract development and manufacturing organisations (CDMOs) to make life-saving therapies.

Australia is an ideal manufacturing base in the Asia-Pacific. Its competitive advantages include a highly developed medical innovation ecosystem; globally recognised regulation and strong IP protection; government grants and incentives; and proximity to Asian markets to facilitate export.

‘Australia has a highly regarded clinical trials network that is known for rapid approval and completion of Phase I clinical studies,’ says Ian Wisenberg, CEO of BioCina, a full-service contract development and manufacturing company. ‘It makes sense to manufacture products close to the clinical trial site, and vice versa. It is much more cost-effective and efficient for the drug sponsor.’

Multinationals manufacturing in Australia

In 2021, Novartis announced it would start manufacturing its CAR-T therapy, Kymriah®, in Australia. Australia is one of only seven Novartis CAR-T manufacturing sites worldwide. The treatment will be made at Cell Therapies’ facility within the Peter MacCallum Cancer Centre.

Cell Therapies is an Australian CDMO that specialises in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products. Cell Therapies partners with Peter Mac’s Centre of Excellence in Cellular Immunotherapy Translation Laboratory to take novel cellular immunotherapy approaches to clinical trials.

International companies building their own facilities in Australia benefit from the country’s highly skilled life sciences workforce and expansive health and research infrastructure.

US biotech Moderna has finalised an agreement with the Australian Government to build an mRNA vaccine manufacturing facility in Victoria, the first in the Southern Hemisphere. Moderna will manufacture a range of mRNA vaccines against respiratory viruses, including COVID-19 and seasonal influenza. The facility is expected to start operating in 2024, pending regulatory and planning approval. Moderna expects to produce up to 100 million vaccine doses each year.

Moderna’s facility will bolster Australia’s already strong biotechnology and medical manufacturing sectors. It will provide high-skilled jobs and bolster domestic supply chains, clinical trials and R&D.

CSL subsidiary Seqirus is building an A$800 million cell-based influenza vaccine manufacturing facility in Victoria. It will be the only such facility in the Southern Hemisphere. Seqirus will make its proprietary adjuvant MF59® and unique products for Australia’s public health needs, including antivenom and the world’s only human vaccine for Q-Fever.

Biopharmaceuticals manufacturing expertise

Biopharmaceuticals manufacturing is one of Australia’s major strengths. Australian contract development and manufacturing organisations have expertise in:

  • antibody therapies
  • recombinant proteins and vaccines
  • autologous cell therapy
  • aerobic and fully anaerobic fermentation of bacteria and yeasts
  • plasmid DNA
  • plasma therapeutics.

Manufacturing facilities in Australia are a mix of private companies like Luina Bio and Patheon and publicly funded organisations including the National Biologics Facility and Q-Gen.

The National Biologics Facility is a collaboration between the University of Queensland, University of Technology Sydney and CSIRO. It offers custom manufacturing solutions for biological therapeutics. It has expertise in molecular biology, phage display, antibody discovery and engineering, mammalian cell culture, recombinant protein production, and biopharmaceutical development.

Australia has strong expertise in cellular immunotherapies, where it has been a pioneer for decades. QIMR Berghofer Medical Research Institute established a cellular immunotherapy manufacturing facility called Q-Gen Cell Therapeutics in 2000. Q-Gen is accredited by Australia’s Therapeutic Goods Administration as a Good Manufacturing Practice (GMP) facility. The facility can produce cellular immunotherapies for patients in Australia, Asia, the US and Europe.

Partnerships and collaborations

Australia’s universities, research institutes and cooperative research centres are leaders in biologics R&D. They offer plenty of partnering opportunities to make and commercialise leading-edge therapies.

US biotech Cytiva is partnering with Australia’s BioCina and the University of Adelaide to develop the next generation of mRNA vaccines and therapeutics. The partnership will aim to speed mRNA-based product development and make them more stable. This will accelerate progress to clinical trials for future vaccines and other diseases, including cancer. Read the case study BioCina: Developing technologies to support the next generation of mRNA-based therapies.

Trade and partnership opportunities with Asia

Demand for health therapeutics in Asia is growing in line with its ageing population. The share of the population aged 65 years and over is expected to increase by nearly 2.5 times in the next decades (source: OECD, Health at a glance: Asia/Pacific 2020, November 2020). Treatments for the two leading causes of death – cardiovascular disease and cancer – will be welcomed.

Australia’s proximity to and close business ties with Asia offer trade opportunities. Medicines manufactured in Australia can be exported across the region. Australia has free trade agreements with Asia’s largest economies, including China, Japan and Korea, as well as fast-growing Southeast Asian countries. Australia also has strong relationships with Asia’s leading universities and research institutions, opening up possibilities for R&D collaborations.

Grants and incentives to support medical manufacturing

Australia offers grants and incentives to support medical manufacturing. They include:

  • The R&D Tax Incentive offers tax offsets for eligible R&D expenditure, reducing the cost to businesses of undertaking R&D activities
  • The Patent Box is a A$206 million scheme to reduce taxes on income from Australian medical and biotech patents. It aims to encourage businesses to undertake their R&D in Australia and keep patents here.
  • The A$2.5 billion Modern Manufacturing Strategy helps manufacturers scale up, compete internationally and create jobs. Medical products are one of six designated priority areas, making Australia’s medical manufacturers eligible for co-funded grants.

Innovate. Evaluate. Expand. Do it all in Australia. Visit our Austrade international site to read more about Health and life sciences.