AusBiotech launches National Cell and Gene Manufacturing Blueprint

Posted: 24 July 2023

A new National Cell and Gene Manufacturing Blueprint launched today, outlining how, with a united and coordinated plan, Australia can realise its potential to become a cell and gene (C&G) manufacturing hub for within the Asia-Pacific (APAC) region.

As the global C&G industry continues to develop apace, this industry-developed strategy presents a unified and collaborative approach to expanding sovereign C&G manufacturing capabilities and capacity in Australia. It outlines recommendations on how Australia’s ecosystem can work together to develop the necessary infrastructure, workforce and expertise, to position Australia as a regional leader and deliver a new generation of medical treatments.

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.”

Cell and gene therapies (C&G products) are a new frontier in medicine, having already demonstrated life-saving and life-changing results for patients with rare diseases and cancer, and show promise in addressing additional, more common conditions. 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.

The Blueprint addresses five key areas outlined in the strategic roadmap from the 2021 AusBiotech-led Regenerative Medicine Consortium Project: 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.

National objectives within each category were developed, refined, and assessed for support, before a second consultation phase was undertaken to develop tactics for achieving those objectives. 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.

The Blueprint also provides approaches to each challenge, tactics to meet key objectives, and key metrics for tracking industry growth.

The Blueprint has been developed with both industry and government in mind. For industry, the report presents and 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.

The Blueprint will support AusBiotech’s policy and advocacy work and discussions with Federal Government.

The National Cell and Gene Manufacturing Blueprint was funded by the Victorian Government’s Australian Medtech Manufacturing Centre (AMMC).

To read the full report, click here.

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