AusBiotech has today launched the Australian biotechnology sector-led National Cell and Gene Manufacturing Blueprint, providing a unified and collaborative approach to expanding sovereign cell and gene (C&G) manufacturing capabilities and capacity in Australia.
Without such a plan, we risk missing out on the benefits of C&G manufacturing to both the Australian economy and healthcare system, including for patients in desperate need of novel therapies.
The AusBiotech-commissioned Blueprint, which has been developed with both industry and government in mind, outlines recommendations on how Australia's ecosystem can work together to develop the necessary workforce, expertise and infrastructure, to position Australia as a regional leader and deliver a new generation of medical treatments.
As the global C&G industry continues to develop apace, this industry-developed strategy provides a roadmap for Australia to become a regional C&G manufacturing hub for the Asia-Pacific, and provides a vision for manufacturing C&G products in Australia; outlines where we are now as a country; and recommends a 'blueprint' of implementation strategies for manufacturing C&G therapies locally.
AusBiotech CEO Lorraine Chiroiu says, "This report is an opportunity to harness Australia's role in the global cell and gene ecosystem, and to ensure that we are best-placed as a nation to be involved in and benefit from these life-changing therapeutic approaches now and into the future. In order to secure Australia's position as a critical hub for cell and gene manufacturing, timely Government support and funding is essential to fully realising opportunity lying in front of us."
C&G products are a new frontier in medicine, and having already demonstrated life-saving and life-changing results for patients with rare diseases and cancer, and showing promise in addressing additional, more common conditions, the demand for the growing and diversifying suite of therapies is high. While the initial scientific challenges of C&G products have been overcome, the manufacturing and delivery requirements remain complex and diverse, with the increasing number of therapies pushing global manufacturing capabilities and capacity to the limit.
For industry, the report presents an opportunity to shape the field for the future, and to build a sustainable and growing ecosystem that attracts and supports local and international operators, while for government it presents an opportunity to strategically invest and therefore maximise the socioeconomic potential of C&G manufacturing, including job creation and healthcare outcomes.
Project partner Biointelect was pleased to have partnered with AusBiotech on developing the strategy. Co-founder Jenny Herz says, "Cell and gene therapies are at the forefront of healthcare innovation and with a robust pipeline of therapies addressing increasingly common conditions, we have a unique opportunity to leverage our local strengths in research and clinical trials, improve access for Australian patients and drive the growth of an export industry. The report lays out strategic pathways to attract international C&G developers to manufacture in Australia, with a specific focus on delivering to emerging Asian markets."
Eleven key recommendations to support local C&G manufacturing have been identified in order to overcome four key challenges:
- Challenge 1: Addressing critical and growing skills gaps in cell and gene manufacturing
- Challenge 2: Building critical mass in Australia's cell and gene manufacturing ecosystem
- Challenge 3: Optimising Australia's contributions to the C&G product pipeline
- Challenge 4: Tracking and guiding industry growth.
Supported by the Victorian Government's Australian Medtech Manufacturing Centre (AMMC), the Blueprint was developed by AusBiotech, the Cell and Gene Manufacturing Taskforce, and Biointelect with both industry and government in mind. Thank you to the individual contributors and the Cell and Gene Manufacturing Taskforce, comprised of Guillaume Herry (Acura Bio), Ian Wisenberg (BioCina, Bridgewest Group), Silvio Tiziani (CCRM Australia), Jennifer Hollands (Cell Therapies Pty Ltd) and Susie Nilsson (CSIRO), Margret Schuller (NSW Stem Cell Network), and Heather Donaghy (Therapeutic Innovation Australia).
The Blueprint addresses five key areas outlined in the Strategic Roadmap for the Regenerative Medicine Sector: workforce skills development, long-term investment opportunities, strengthened collaboration across the value chain, capability across the value chain, and clear market access pathways aligned with leading global markets.
To read the full report, click here.
