Safety & Manufacturing
Safety & Manufacturing
Commitment to Quality and Safety
Every day at CSL Behring, we work as if someone’s life depends on it, because it does. It starts with the molecules our scientists study, test, and develop into therapies, progresses through the manufacturing process into the shipping and storing of our medicines, and ends in the bodies of our patients, helping them to live fuller and longer lives.
We are committed to producing high-quality, safe and effective medicines and to us, that means that each step of the manufacturing process must meet or exceed the most stringent international standards for product safety in accordance with regulatory agencies worldwide. Our dedication producing the highest quality products is well known in our industry and throughout the patient communities we serve. Whether these medicines are plasma-derived or recombinant, CSL Behring selects the highest quality starting materials, and ensures the quality and safety of its medicines by testing at various stages combined with multiple pathogen reduction steps in its manufacturing processes, implementation of good manufacturing practice (GMP) according to the most current regulatory guidance, as well as surveillance by pharmacovigilance.
CSL Behring’s Australian manufacturing site in Broadmeadows, Victoria
Since 2010, CSL Behring has invested in three substantial new manufacturing facilities at our Broadmeadows site.
Biotechnology Manufacturing Facility
• One of Australia’s largest and most advanced biotechnology facilities, for the manufacture of new recombinant protein therapies for use in late stage clinical development for a range of conditions.
Turner PRIVIGEN® Facility and AlbuRx® Facility
• PRIVIGEN (intravenous normal immunoglobulin, 10%) and AlbuRx (Human Albumin 5% & 25%) are global CSL Behring therapies manufactured from plasma collected by CSL Plasma in the US and Europe.
• Commissioning of these two facilities at Broadmeadows will substantially expand CSL Behring’s global production capacities and see product manufactured in Broadmeadows Victoria exported for supply to patients globally across the CSL Behring network, to meet growing global need for these important therapies.
Integrated Safety System
An integrated safety system for the production of plasma-derived products starts with the selection of donors and testing of donations. The system includes purification of the desired protein, virus inactivation and prion removal in addition to multiple levels of quality assurance, including both quality control and monitoring. The integrated safety system is comprised of the below processes: