Innovative manufacturing in Australia's emerging regenerative medicine industry: centralised factories to decentralised facilities

Regenerative medicine therapies are showing great clinical promise in providing cures to life-threatening diseases such as cancer and diabetes. However, little emphasis has been placed on the industrialisation of these therapies for commercial purposes. The inability to scale production up and out to meet pending demand is of increasing concern to both regulators and funding agencies. Using an open innovation theoretic lens, this paper explores the importance of involving commercial partners within the lengthy research and development phases. We adopt a case study method to show that laboratory processes that incorporate innovative manufacturing techniques produce significant reduction in cost of quality (errors) and improved scalability, while satisfying regulatory requirements. We demonstrate that this approach enables faster industrialisation, and improves the funding efficiency of clinical trial outcomes in terms of quality, cost and commercial success of therapies.