2025 ISPE FOYA Category Winner for Pharma 4.0™

CSL Project Aurora is a significant base fractionation expansion initiative at the Broadmeadows Campus in Victoria, Australia. The project enabled end-to-end manufacturing at the site by supplying the intermediate products from plasma to CSL’s existing immunoglobulin and albumin facilities. The company aligned all products manufactured at Broadmeadows with the global product platform. The facility is the largest of its kind in the CSL network, increasing the site’s capacity to nine times its previous level and reaching the equivalent of over 10 million liters of plasma per year. The facility produces intermediates for immunoglobulin and albumin products, as well as products to treat hemophilia, which are all vital for the global patient community. These products meet the growing global demand for plasma-based therapies, essential for treating conditions such as immunodeficiencies, neurological disorders, and burns. They are used by patients and healthcare professionals worldwide, including cancer patients and patients in need of transplants and surgical procedures. CSL’s investment in this facility underscores its commitment to biopharmaceutical innovation, focusing on developing new therapies and enhancing existing ones.

CSL’s application of technology and innovation is seen across multiple aspects of the facility design and operations. Process innovation is seen in areas like the advanced filtration technology that emphasizes sustainability through reusable filter membranes while using robotic cleaning systems to ensure repeatable, compliant processes. The use of robotics and automation does not stop there. Across the facility, CSL has consistently applied the use of robotics and automation to remove manual steps and ensure consistency and accuracy. The central warehouse was also automated with a fully equipped automated storage and retrieval system (ASRS) and automated guided vehicles (AGV) for distribution throughout the facility.

The powder handling process was fully automated to remove the exposure to the operators from the process. This system decants and dispenses powder materials from flexible intermediate bulk containers within the central powder handling clean room. It uses pneumatic batch transfer to move powders into individual process vessels via vacuum receivers. Each powder handling system is a closed, dedicated system for a single powder, thereby eliminating the risk of exposure, contamination, and cross-contamination. Robotic, automated machines were developed to continuously remove frozen plasma from individual donor bottles and bags. They then feed the empty bottles directly to an automated shredder, eliminating the manual handling of waste, enhancing the operator safety, and minimizing the overall volume of waste. The system is also used to simulate process changes a significantly reduce the risk and mistakes when they are deployed.

CSL has further committed to the automation and digitalization with the incorporation of full manufacturing execution system (MES) for manufacturing and the application of a digital twin and data analytics. The company has seen 98 percent right first-time production through the use of this technology. The full integration of the MES and quality systems has reduced batch review times by 87 percent and decreased deviations by 20 percent. The enhanced data management across the MES, enterprise research planning software (ERP), and laboratory information management systems (LIMS) and has supported CSL’s focus on real-time data, monitoring, and analytics. The digital twin is used to develop a highly detailed dynamic process simulation. This was used to analyze all process and cleaning steps. This allowed for detailed scenario-based dynamic simulations used to identify and prioritize process bottlenecks and continuous improvement initiatives and optimize operational staffing models.

Based on the full-scale application and integration of the various robotics and automation technologies, CSL is recognized as the 2025 ISPE FOYA Category Winner for Pharma 4.0™ for their Project Aurora in Australia.

Supply Partners and Key Participants:

Engineer/Architect (A&E): Wood PLC, ACOR Consulting and Billard Leece Partnership

Commissioning Qualifications & Validation Services: CSL Behring

Main/General Contractor and Construction manager: ICON

HVAC Subcontractor: AG Coombs

Automation and Control supplier: MESCADA

Automation Supplier: Siemens GmbH

Major equipment supplier or contractor: Dematic, HoF GmbH, Magurit, Brinox, NDA, Furphy, GEA Centrifuges, Muller Processing, Veolia Australia, Stilmas, Endress and Hauser, Gemu Valves Australia, Strassburger GmbH

Piping Subcontractor: CSL Direct Managed

Piping supplier or contractor:

• TFG Group
• Pure Piping
• TPM
• Egan & Stewart
• DMAC Fabrications
• IPT