Biologics facility to supercharge Australia’s vaccines and therapeutics manufacturing

Biotech News: With funding support from MTPConnect, CSIRO’s new $23.1 million biomanufacturing facility in Melbourne has been opened by Industry and Science Minister, Hon. Ed Husic MP.

“Australia’s competitive advantage in manufacturing lies in high-value, high-quality products where competitiveness, productivity and quality can be enhanced through advanced manufacturing processes and systems,” Minister Husic said.

He added “The new National Vaccine and Therapeutics Lab exemplifies the translational role our national science agency plays in Australia’s biomedical ecosystem. It will help vaccine and drug candidates get ready for commercial production by Australian industry for local and global markets.   

“As the newest member of Australia’s National Labs network, the facility will bring our research and university sector together with local start-ups and small to medium enterprises to ensure great Australian ideas make it out of the lab and reach those that need it quickly and safely.”

The new lab follows a successful pilot facility in the early stages of the COVID-19 pandemic, when CSIRO scaled up vaccine candidates that had been developed onshore as part of a national strategy to combat this emerging threat. The ability to do this in Australia, rather than needing to go overseas, has been the ‘missing link’ in Australia’s biomedical science sector being able to produce vaccines and drugs here. 

CSIRO’s Chief Executive Dr Larry Marshall said the new National Lab would lift Australia’s ability to protect its people and grow new industries.  

“We created the pilot facility in anticipation of disease “X” – an expected but unknown disease that might impact us.  It  turned out to be COVID-19. The past two years have highlighted the importance for Australia to have a robust sovereign capability in the development of vaccines and therapeutics, so we scaled it up into one of our shared National Labs,” Dr Marshall said. 

“The problem facing our biomedical industry has been that most vaccine and drug candidates needed to be sent overseas to be produced in large quantities for clinical trials, adding burdensome costs that have crushed many Australian businesses and researchers as the invention languishes on the lab bench. 

“This new shared National Lab will help Aussie companies bridge that ‘valley of death’ – the gap between the lab bench and making a product that’s having an impact on people’s lives.” 

Attending the official opening, MTPConnect Chair Sue MacLeman said this new facility fills a gap in biomedical capabilities for sovereign advanced manufacturing.

“This new CSIRO facility further strengthens Australia’s biologics advanced manufacturing capability and will support increased productivity and competitiveness of our MTP sector,” Ms MacLeman said.

“Manufacturing onshore can be faster and more cost effective than manufacture overseas, meaning more Australian discoveries could move from the bench, through clinical trials and eventually into the clinic – leading to better health outcomes for patients and more economic value from Australian research being captured in Australia,” she said.

MTPConnect CEO Stuart Dignam praised the project’s collaborative approach as one of the keys to its success.

“What started with a business plan, lab design and purchase of equipment has led to the opening of a facility of national importance for Australia’s biomedical efforts and our clinical trials industry,” he said.

“Importantly, the project also supported the skilling-up of our future workforce with training support in quality systems, GMP, analytics and bioprocess development,” he said.

Research Director for Biomedical Manufacturing, Prof Susie Nilsson said the facility was available to companies and researchers around the country as another of CSIRO’s National Labs. 

“This new lab has been designed and constructed in accordance with the current licensing requirements of the Australian Therapeutic Goods Administration to produce a variety of biologics, including recombinant proteins and peptides, and viral products,” Prof Nilsson said.  

“Our team at the lab will produce drugs in partnership with local industry and enable our partners to progress to both phase one and phase two clinical trials in Australia, and also has the necessary accreditation for Australian companies to participate in clinical trials globally.” 

The development of the facility was supported with funding of $1.1 million from MTPConnect’s Growth Centre Project Fund and leveraged a further $3.4 million in industry co-contributions and state government funding, bringing the total value of MTPConnect’s contribution to the project to $4.5 million.

The biomedical industry is a priority growth area for the Australian Government and is estimated to add more than $8 billion gross value to the economy over the next 10 years.