Industry interest in regenerative medicines is increasing. In 2019, the US FDA predicted there would be 10 to 20 new cell and gene therapies a year by 2025, based on an assessment of pipelines and clinical success rates.

And, despite COVID-19, this trend has continued according to Melbourne-based Ausbiotech, which reported in September that the global regenerative medicines sector attracted $19.9 billion of investment in 2020.

This sustained industry interest is a significant opportunity for Australian biotech, according to Ausbiotech, which says the country could generate at least $6 billion in annual revenue and create 6,000 new jobs by 2035.

The challenge will be building the manufacturing infrastructure needed to compete on a global scale says Ausbiotech communications director, Karen Parr.

“Regenerative medical therapies require highly-specialized GMP capabilities and infrastructure, a highly-skilled workforce, and complex supply chains,” she says. “The increasing demand for RM therapy manufacturers is growing and a major bottleneck exists at the GMP manufacturing phase of product development, both in Australia and globally.”

Capacity boost

Capacity for cell and gene therapy production in Australia is limited. According to analysis by Ausbiotech the country has only 34 cleanrooms—the combined cleanroom and QC footprint is 2,982m2—and employs just 231 full-time and 45 part-time employees.

To capture a bigger share of the global regenerative medicine (RM) manufacturing market this will need to change, stresses Parr.

“There are significant benefits to having manufacturing facilities located onshore in Australia, for patients as well as RM therapy developers: local manufacturing will build resilience for the sector and ensure faster access to cutting-edge therapies for all Australians,” she tells GEN.

“Sovereign capability facilitates access not only to early phase trials for Australian patients for locally developed products, but also supports access to innovative and cutting-edge international trials.”

Vectors moving in the right direction

Sourcing viral vectors is also a challenge for Australian biotechnology companies because, at present, the country has no facilities with the capability to manufacture GMP-grade vectors. However, this will soon change. In 2019, the New South Wales state Government invested A$25 million to expand capacity at the Westmead Viral Vector Manufacturing Facility in Sydney.

The expansion plan will add commercial-scale capacity to the facility’s current small scale production capabilities for gamma retroviruses, adeno-associated virus (AAV), and lentiviral vectors.

Parr sees this investment as a positive sign for the wider regenerative medicine manufacturing sector in Australia and beyond.

“This progressive direction demonstrates that Australia’s capabilities are growing, and greater opportunities are available for the sector if further investment is pledged,” she notes. “By leveraging Australia’s reputation for delivering high-quality, complex, and safe medical products, as well as our highly-skilled workforce, we can become the clinical trials and manufacturing hub for the region and deliver potentially life-changing treatments to patients, both in Australia, and the broader Asia Pacific region.”