A US initiative is intending to kick start an industry in purpose built organs and tissues for human transplantation. Could we do the same thing in Australia – maybe even lead the field?
The World Health Organization says around 422 million people are living with diabetes worldwide, with 1.5 million deaths attributed to the disease every year. The US National Kidney Foundation says over two million people are receiving kidney treatment with either transplants or dialysis.
The human suffering is staggering, to say nothing of the public health bill – $3.4bn in Australia on diabetes alone.
We’re 3D printing concrete, glass and wood – why not organs, built from cells donated by the patient, vastly reducing the risk of the body rejecting transplanted organs?
3D printing organic structures isn’t new. We’ve done it with bones and cartilage, and scientists in Korea recently produced 3D blood vessels with viable pores.
As both healthcare costs and the human population balloon, biofabrication might be the most important new manufacturing technology of the near future. But proof of concept in a lab is a long way away from bespoke hearts, lungs or livers rolling off a production line. How will we get there?
“We’re some way from it, but it’s achievable,” says Professor Gordon Wallace of the University of Wollongong’s Australian Institute for Innovative Materials. “Advances in a number of industries need to align and converge.”
When that happens, biofabrication is going to be not just an urgent social need but a potentially gigantic market. It’s one a US initiative called the Advanced Regenerative Manufacturing Institute (ARMI) hopes to kick start. ARMI is a pre-competitive cluster of life sciences companies and research organisations collaborating to perfect the at-scale commercial production of purpose built human organs and tissues.
Established with a US$80m grant from the US Department of Defence, the lynchpin of ARMI is BioFabUSA, a nonprofit that wants to integrate cell and tissue culture science with advances in bio fabrication, automation, robotics and analytics to create scalable manufacturing processes.
Since its inception a few years back, BioFabUSA has grown to over 100 members. “To get an industry up from nothing we’re going to need standards and systems,” says Inventor and tech entrepreneur Dean Kaman (famous for the Segway), who’s leading ARMI’s development. “We need a massive infrastructure to turn this into a high-volume business.”
Advance Australia
But while ARMI might be the only biofabrication industry purpose built to make a the technology widespread and affordable, it’s not the only body advancing the science in the field.
As famous as we are for world-renowned research and higher learning institutions in Australia, local scientists, companies and programs are well-represented in biofabrication.
Does that mean Australia might be a critical market in the industry’s development? A CSIRO report from February 2024 said the field of synthetic biology could be worth $30bn and create 50,000 new jobs by 2023.
And some are already following ARMI’s example. In August 2023 the Victoria state government announced $5.75m to establish the Victoria Medtech Skills and Device Hub at Melbourne’s St Vincent’s Hospital, which will bring business and universities together and offer over 1,000 training places to get tomorrow’s biofabrication industry ready.
Another is the University of South Australia’s Future Industries Institute, an initiative that will use 3D printing to combat everything from blindness to epilepsy.
According to the Institute, the diseases that have baffled scientists for centuries are all based in misfiring neurons, so the answer is carbon-based biocompatible inks printed into soft flexible devices that can be surgically implanted, electronically communicating with the neural network on demand.
The idea of 3D printed organs and tissues might also make you think of an enormous, pristine factory packed with multibillion dollar equipment, the sort of place they make semiconductors and which we don’t really have the capacity for in Australia.
But when AMT Magazine toured ARMI late in 2023, the action was taking place in some labs and a clean room not much bigger than a university lecture hall. Our first thought was ‘couldn’t someone at home do this quite easily?’
“While we haven’t had funds from the Australian government anywhere near ARMI’s $80m, there are smaller players making great strides in this space,” says Professor Laurence Meagher, director of ARC CTET – the ARC Training Centre for Cell and Tissue Engineering Technologies, a partnership between Monash University, the Queensland University of Technology and 22 partner organisations.
“Most academics aren’t trained to develop a product and understand markets, and universities aren’t equipped or funded to do more than the basic research. So we need to improve understanding of how this all works. One of the things we’ve focused on is workforce development, just for these types of applications.”
One of the technical obstacles to scaling any personalised medicine is that it increases cost – non personalised (also called allogeneic) cells and samples are easier to scale. To help establish a research/commercialisation pipeline, ARC CTET has been working with a company called Gelomics Pty Ltd to 3D print human skeletal muscle cells, and they’re at almost at the pre-clinical model stage. “Working directly with a company gives us a path to market,” Meagher says.
But while Australian expertise and local industrial infrastructure that can take part in giving people new kidneys, eyes or bones shows promise, do we have the potential to actually lead the way?
Associate Professor Laura Bray, ARC CTET’s deputy director, thinks we have the skills, but there’s a gap in product development and regulatory expertise, which she says is mostly locked up in commercial enterprise rather than science and research.
But she adds that the graph is showing an upswing. “AusBiotech recently said there are around 100 Australian companies in tissue engineering and regenerative medicine, and SME numbers in the field are expected to increase exponentially over the next 10 years,” she says. “Overall the field is poised to go from proof-of-principle to clinical validation and ultimately standardisation, paving the way for commercialisation.”
“The challenges ahead are around fragmentation in the industry, a lack of personnel who are well versed in the skillsets, scaling production to a commercially viable level, optimising advanced manufacturing technologies and processes like automation and the cost of goods associated with scaffolds and cell carriers, media and growth factors,” she says.
Bray considers Australia a leader in taking new technologies through regulatory pathways, but says we just need to reduce fragmentation and streamline the development of cell-based tech into viable products. “Recent reports about Canada, and we have a comparable sector in Australia, said a dedicated centre with strategic infrastructure investment, targeted funding and expertise would do that.”
At the University of Wollongong, Wallace is more emphatic. “Yes, we have the potential to lead,” he says, “But we’ll need to lead on all fronts – technical, clinical, commercial and regulatory. The industry/commercial models are still emerging but we’re fortunate to have an integrated researcher-clinician ecosystem.”
The public interest
But as well as investing in the industry and expertise at the start-up level, the government also has a role to play because it needs to regulate the therapies on offer when we 3D print organs.
Will (or can) it put its money where its mouth is and facilitate a smooth ride when the time comes instead of throwing up barriers to innovation when makers and marketers are as keen to unleash biofabrication as patients are to use it?
Cell-free materials (ie not containing any biological source material) are easier to get regulatory approval for, but bioprinted constructs are combination products, which makes them higher risk – more constituent elements basically means more things can go wrong.
Costs are also an issue. Reimbursement from insurance companies or government health schemes is uncertain until a production pipeline and patient efficacy measures emerge, so they might be out of the reach of most consumers.
That means regulating it properly is extremely hard until costs come down thanks to scale and automation, which will in turn shorten the development cycle and improve quality and safety.
“Yes, regulation will slow things down,” Wallace says, “and so it should.” He adds that the key thing is to balance risk versus reward – if other countries beat us to it the ship will have sailed, but so far he’s encouraged by the willingness of the Therapeutic Goods Administration (the Australian regulator) to engage with researchers and clinicians in the early stages.
So if we want to see livers, kneecaps or cochleas sent overseas with ‘Made in Australia’ tags dangling from them, there are certainly hurdles to be cleared, but we have a chance…