Australia has long been a pioneer of biomedical research, but must leverage the capabilities of advanced manufacturing to maintain its competitive advantage.
Dr Peter French, Executive Director, BCAL Diagnostics and Bioxyne Limited, said: “There is a rich pipeline of gene therapy products currently in the clinic and the gene therapy market is estimated to reach $11 billion by 2025.”
Despite the many companies transitioning into late-stage clinical trials and commercial launch, many lack the capabilities to manufacture gene therapy products on a commercial scale. As a result, it will be a challenge to manufacture sufficient doses to meet potential global demand.
Presenting at the Advanced Manufacturing Summit 2016 next week, Dr French will outline how innovative manufacturing can offer solutions to meet this challenge and will discuss requirements for developing a scalable gene therapy manufacturing facility in Australia.
David James, CEO Scinogy, will also present at the Summit, highlighting the importance of patient safety, product quality and cost of goods in delivering commercial success in biotech.
Mr James said: “Choosing a suitable scale-up strategy for a therapy is a complex process, influenced by the decisions already made and the commercial and regulatory constraints within which each business must operate.”
While manual processes are convenient during clinical trials, they are not suitable for commercial scale manufacture and can be difficult to transfer from one location to another.
“By providing companies undertaking clinical trials with scalable, reproducible and commercially viable processes, we help make revolutionary therapies a reality for patients around the world.”
The Advanced Manufacturing Summit 2016 will be hosted by AusBiotech from 15-16 November in Sydney. The Summit will feature a program of industry experts to explore the future of innovation-driven advanced manufacturing, discuss how Australia can leverage its existing competitive advantage in manufacturing and examine its role in biotechnology, medical technology and pharmaceutical development. Register or find out more.