Biocompatibility Redefined

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Thursday, September 27, 2018Description :
Biocompatibility Redefined. presented by Jean-Marc Cappia, Head of Segment Marketing, Vaccines https://goo.gl/X259XH Extractables, leachables and particles can interact with biologics by generating nucleation, aggregates, unfolding and inactivation. Thus may affect the quality and safety of your biologics. Once validated for your specific process, our single-use solutions guarantee consistently low and reproducible levels of extractables and particles. This level of quality is the result of our entire control of the fluid path through unique partnership, supply control and quality agreements with our film extruder and resin supplier Südpack. In addition we correlate our extensive extractables, leachables and particles data and the information of the BPOG risk assessment guide and study design protocol with your specific process conditions. This approch creates a ready-to-file process-related extractables report which makes your processes faster and cheaper than ever. This demonstrates how we are building the foundations for end-to-end single-use manufacturing.

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