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A global genomic revolution is currently in full swing, with significant advances in gene editing, DNA sequencing, CRISPR, therapeutics, and molecular diagnostics. However, manufacturing for viral vectors – the engineered viruses that carry genetic materials to host cells – is lagging behind global demand, delaying clinical trials and the progression of new genetic therapies to market, often by years.
Geneticist and biomedical reseacher, Professor Ian Alexander, (a keynote presenter at this year’s Bio Connections Australia Conference) believes it is time to increase Australia’s domestic capability for vector manufacturing and relinquish our dependence on international third party suppliers. Currently Australia contributes 3 per cent of the world’s biomedical research output, but under-produces vectors, failing to meet even its own domestic demand, let alone that from potential export markets.
The fallout of this, Ian says, is huge with a significant number of anti-cancer and rare disease therapies held up by the shortfall. Financially, too, the impact is significant with the global cell and gene therapy market expected to grow at a compound annual growth rate of 33.82 percent, reaching $8.95 billion by 2025.
“We are at a point in the genomic revolution where we are very likely to be able to tell a family they have a child with a particular genetic diagnosis, but the next, more pressing, question becomes, what can we do about it? In other words, we have a flood of knowledge and diagnostic power, but comparatively little therapeutic power. It is a frustrating situation, when we have so much therapeutic research out there, held back only by a logistical stumbling block,” said Ian.
The COVID-19 pandemic has put added stress on the situation globally, with AstraZeneca’s vaccine heightening demand for adenovirus vector technology – one of the top three most common vectors for genomic research and therapeutics development. “We absolutely had to meet the need for adenovirus vectors to halt the pandemic, but in the short term it has put more pressure on global capacity,” said Ian.
Ian’s own research into genetic liver disease in collaboration with the University of College London has incurred a two year delay as a result of the global shortage. “We have done a lot of pre-clinical work and are ready to move into novel therapeutics to treat children with genetic liver disease. But the log-jam held us back by two years as we awaited vector supplies,” he said.
Ian’s scenario is particularly common in the academic space, he says, where third party reliance is stronger and budgets are typically smaller. “The big fish are often able to look after themselves. Late phase trials are commonly much larger and looked after by the big end of town with deep pockets. Things are more intense at the proximal end of the developmental pathway, where a vast number of bespoke therapies are being created and you need smaller quantities of a high quality vector.”
But even Big Pharma is under pressure for vector supplies, with so many new therapies coming through. “We are seeing a lot of anti-cancer therapies being held as a result,” Ian added.
The challenges are also felt more profoundly by researchers of certain diseases. “In eye disease for example, you only need a small volume of virus to treat a human retina. For genetic liver disease, you have to treat a whole liver. The volume required is potentially 1000-fold higher,” said Ian.
In light of these challenges, The NSW Department of Health has committed support to this area with the establishment of a pilot scale facility. Efforts to expand this to an intermediate or large scale facility are underway and will help meet both domestic and global demand for vector technology.
Ian and colleagues are also working on an important initiative for bolstering vector supply on Australian shores, details of which he will be sharing at the Bio Connections Conference.
“It is still early days and we have a long and complicated journey ahead, but the reward for getting there is huge. If we can get that pathway working in Australia we can start developing more therapies quicker, with significant health, social and economic benefits. We can enliven our biotech industry and market our therapeutic products to the world. It’s an exciting prospect,” he concluded.
Professor Ian Alexander is Clinical Geneticist, FAHMS, Director Laboratory Research and Senior Staff Specialist, The Children’s Hospital at Westmead, Professor in Paediatrics and Molecular Medicine, University of Sydney & Head of the Gene Therapy Research Unit, a joint initiative of Children’s Medical Research Institute and The Children’s Hospital at Westmead (CHW).
Hear about the exciting work he is doing to advance vector manufacturing capability at the Bio Connections Australia Conference. This year’s event will be held 18 November at the Rydges Melbourne.
Register now to secure your seat.
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