CSL is an Australian-owned global biotechnology company with a portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Founded in Melbourne in 1916, CSL today comprises three businesses—CSL Behring, CSL Seqirus, and CSL Vifor—that provide lifesaving products to patients in more than 100 countries and employ over 32,000 people.
Located in Broadmeadows, Victoria, Australia, CSL Behring’s Project Aurora Plasma Base Fractionation Facility (Facility F) is the largest of its kind within the CSL network and globally. It aligned all products manufactured at Broadmeadows with the global product platform and increased the site’s capacity nine-fold, processing over ten million liters of plasma per year. The facility produces intermediates for immunoglobulin, albumin, and hemophilia products, which are 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 transplants, surgical, and cancer patients. 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 can be found across multiple aspects of Facility F’s 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 they have 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 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 and significantly reduce risk and mistakes when they are deployed.
CSL further committed to automation and digitalization with the incorporation of a full manufacturing execution system (MES) for manufacturing and the application of a digital twin and data analytics. Werum PAS-X MES improves the quality of products and processes by as much as 98%. The full integration of the MES and quality systems has reduced batch review times by 87% and decreased deviations by 20%. The enhanced data management across the MES, ERP, and LIMS systems has supported their 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 Behring is recognized as the 2025 ISPE FOYA Category Winner for Pharma 4.0™ for their Project Aurora - Plasma Base Fractionation Facility.
Supply Partners and Key Participants:
Manufacturer/Owner Name: CSL Behring
Engineer/Architect (A/E): Wood PLC, Australia
Construction Manager: ICON
Piping Subcontractor: Multiple firms
HVAC Subcontractor: AG Coombs
Automation and Control Supplier: MESCADA, Siemens
Major Equipment Supplier:
Dematic
HoF
Magurit
Brinox
NDA
Furphy
GEA Centrifuges
Muller Processing
About the FOYA Pharma 4.0™ Category
Winners in the category embody the Pharma 4.0 concept. This includes not only implementing one or more technological innovations, but also demonstrating the ability to change their culture, processes and people orienting them towards a 4.0 future. Significant contributions include application of one or more applied science-based solutions or digital innovations like automation, robotics, digital twin, or advanced processing understanding; substantial improvement to operational practices; or technologies widely & strategically implemented across the organization. Subcategories include Digital Maturity, Data Integrity by Design, Advancing: Quality, Organization & Processes, Culture, Information Systems, or Resources, Impact and Maturity Model, and Process Intelligence.
Established in 2005, the FOYA program recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches.
ISPE delivers technical and operational solutions to support across the global pharmaceutical and biopharmaceutical industry in the manufacture of quality medicines for patients.
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