Australia could become an Asia-Pacific hub for the manufacture of cell and gene therapy products due to the country’s research, clinical trial, and advanced hospital system strengths, according to a new industry-led report.
The National Cell and Gene Manufacturing Blueprint aims to provide a unified and collaborative approach to boosting Australia’s sovereign cell and gene (C&G) product manufacturing capabilities, leveraging on existing strengths.
The report was produced by peak industry body AusBiotech in partnership with strategic planning and commercialisation firm Biointelect. It was funded by the Australian Medtech Manufacturing Centre, which is an initiative of the Victorian state government.
Cell therapies involve the “transfer of intact, live cells into a patient” while gene therapies involve the “introduction, removal, or change in the content of a patient’s genetic code” to treat or cure a disease.
It has been used to treat rare diseases and cancer, with work underway to demonstrate its use in more common issues.
Despite ongoing ethical concerns about the use of the technology, nine C&G therapies have been approved by Therapeutic Goods Administration leading to the treatment of more than 100 Australian patients since 2018.
That was the same year biophysicist He Jiankui was widely condemned for performing gene editing on human embryos, leading to his suspension and imprisonment.
In 2021, there were 153 active clinical trials in Australia. The global C&G manufacturing was worth US$15.1 billion in 2022, the report says.
It also says Australia already has a strong C&G manufacturing infrastructure base, meaning support should focus on expanding existing facilities to produce at a commercial scale rather than to build new facilities.
According to a 2021 report on Australia’s Regenerative Medicine Manufacturing Capacity and Capability, there were 11 companies engaged in C&G manufacturing across 49 clean rooms. Since then, the C&G report notes that five firms have reported “facility expansions or increased capabilities and a further three new companies reporting manufacturing space”.
Project partner Biointelect’s co-founder Jenny Herz described C&G therapies as being “at the forefront of healthcare innovation”. She said the opportunity to leverage Australia’s existing strengths in research and clinical trials will deliver improved access to C&G therapies and “drive export growth”.
“The report lays out strategic pathways to attract international C&G developers to manufacture in Australia, with a specific focus on delivering to emerging Asian markets,” Ms Herz said.
The report outlines 11 key recommendations to overcome four challenges for establishing a cell and gene product manufacturing ecosystem.
These include a growing skills gap, the need to build a critical mass of C&G manufacturing, and the need to optimise Australia’s contributions to the C&G product pipeline.
C&G research translation in Australia currently faces “high material costs, high standards of quality required, and limited translational laboratory space and access to industry technology platforms and expertise”.
A survey undertaken in 2018 noted that while Australia and New Zealand had a similar number of “cellular therapy product manufacturing facilities and parallel manufacturing processes”, it had a workforce that was smaller by 57 per cent.
AusBiotech chief executive Lorraine Chiroiu said the report was important for guiding both industry development and government support.
“This report is an opportunity to harness Australia’s role in the global cell and gene ecosystem, and to ensure that we are best-placed as a nation to be involved in and benefit from these life-changing therapeutic approaches now and into the future,” Ms Chiroiu.
“In order to secure Australia’s position as a critical hub for cell and gene manufacturing, timely Government support and funding is essential to fully realising opportunity lying in front of us.”
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