The completion of Australia’s only biomedical manufacturing facility in 2023 marks a significant advancement in the production of cutting-edge cell-based therapies, including CAR T-cells, designed to treat blood cancers. Co-funded by the Australian Federal Government, the Peter MacCallum Cancer Centre (Peter Mac), and individual donors, this Good Manufacturing Process (GMP) facility represents a pivotal step in the country’s healthcare and biomedical sectors. Managed by Cell Therapies Pty Ltd., a contract development and manufacturing organisation (CDMO), the facility aims to scale up the production of living cell-based treatments, serving patients throughout Australia and the Asia Pacific region.
As the partner manufacturer for Peter Mac’s Centre of Excellence in Cellular Immunotherapies, Cell Therapies is now equipped to support their Intellectual Property (IP) accelerator platform, which facilitates the translation of Australian-led research into commercialized products. This enhanced capability is vital for bringing advanced, locally developed treatments into the clinical setting. With its state-of-the-art manufacturing technologies, the facility is a key player in advancing research and development in immunotherapy and gene therapy.
One of the defining features of this facility is the integration of sophisticated building management systems, specifically designed to address the unique needs of a biomedical production environment. The facility’s centralized control systems, managed through Honeywell’s Enterprise Buildings Integrator (EBI) platform, ensure optimal operational efficiency and compliance with the stringent regulations of the healthcare and pharmaceutical industries. The Building Management System (BMS) monitors energy usage and collects data to maintain adherence to regulatory standards. Additionally, the deployment of an operational technology (OT) security system safeguards sensitive research activities from cyber threats, while environmental management systems maintain critical parameters such as air temperature and humidity to create optimal conditions within the cleanrooms. Importantly, the facility features fully redundant mechanical services, ensuring that operations can continue seamlessly even in the event of equipment failure.
The deployment of these advanced technologies posed a significant challenge, as they were installed within a live hospital setting, where maintaining infection control and patient safety is paramount. The facility has been thoroughly evaluated against the regulatory standards set forth by the Federal Government’s Office of the Gene Technology Regulator (OGTR) and the Therapeutic Goods Administration (TGA). This rigorous testing ensures that the manufacturing processes meet the highest safety and quality standards for producing cell-based therapies.
Professor Simon Harrison, the director of the Centre of Excellence in Cellular Immunotherapy at Peter Mac, emphasized the significance of the facility’s contribution to the treatment of cancer patients, stating, “These bespoke building technologies are allowing us to deliver groundbreaking therapies that are transforming lives.” His sentiments were echoed by Dr. Bev Menner, CEO of Cell Therapies, who highlighted the facility’s role in advancing Australia’s capabilities in biomanufacturing. “We are proud to operate this world-class facility, producing innovative ‘living drugs’ for Australian patients. The large-scale, high-throughput manufacturing capacity, coupled with our skilled workforce, represents a critical advancement in the development and commercialisation of cell and gene therapy products,” Dr. Menner remarked.
Honeywell, responsible for the facility’s building management technologies, also expressed pride in their role in developing the infrastructure. Laura Laltrello, vice president and general manager of Honeywell Building Automation, commented, “We are honored to partner with the Peter MacCallum Cancer Centre in creating what is truly a one-of-a-kind facility in the southern hemisphere. The bespoke automation solutions we’ve deployed demonstrate Honeywell’s capability to address the unique challenges of the life sciences industry, which is working to tackle some of the world’s most complex healthcare issues.”
Peter MacCallum Cancer Centre is a globally recognised institution dedicated to cancer research, treatment, and education. It is the only public health service in Australia focused exclusively on cancer care. With over 4,000 employees, including more than 700 researchers, Peter Mac is committed to developing better treatment options and potential cures for cancer.
Cell Therapies, as an Australian-based CDMO, plays a crucial role in the production of advanced therapeutic products, including cell and gene therapies, which are now being produced at commercial scale in Australia for the first time. This GMP facility is a cornerstone in Cell Therapies’ mission to support both clinical trial manufacturing and the commercial development of these transformative treatments.
Located within the Victorian Comprehensive Cancer Centre, a $1 billion facility developed through a public-private partnership, Peter Mac’s cutting-edge facility is part of a broader effort to enhance healthcare infrastructure and innovation in the region. Honeywell serves as the services contractor for this facility, working alongside Plenary Health, which manages the project’s financing, design, and maintenance under a 25-year agreement with the Victorian Government. Together, these partnerships are paving the way for continued innovation in cancer treatment and biomedical manufacturing.
