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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 to 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 assures the quality and safety of its medicines by selecting the highest quality starting materials, testing at various stages, inclusion of multiple pathogen reduction steps within its manufacturing processes, adherence to good manufacturing practice according to the most current regulatory guidance (cGMP), and surveillance through pharmacovigilance.

Integrated Safety System

An integrated safety system for the production of biological products starts with the selection of low risk starting and raw materials. The system further includes testing for pathogens at the key stages of manufacturing process and robust capacity of manufacturing process to effectively reduce pathogens in addition to multiple levels of quality assurance, including both quality control and monitoring. The integrated safety system is comprised of the following processes:

Integrated Safety System diagram