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UK/CORP/15-0012l. Date of preparation: July 2015
United Kingdom
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Integrated Safety System

Prions are infectious agents comprised of proteins.  Prions replicate through a mis-folding process whereby an abnormally folded structure converts normal protein molecules into an abnormal form. CSL Behring’s Integrated Safety System ensures the quality and safety of our products. CSL Behring is committed to maintaining the highest standards of quality and safety throughout the production process. Our integrated safety system ensures that only the highest quality plasma is selected for use in manufacturing to ensure the safety and efficacy of our products. Quality control measures, including extensive inspections, tests and cross-checks are performed by highly trained personnel at each stage in the manufacturing process.

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 six processes:

UK/CORP/15-0012b Date of preparation: July 2015