The Proper Use of Extractables Data: Aspects Beyond Extractables Measurement

This webcast features: Dr. Armin Hauk, Lead Scientist, and Jean-Marc Cappia, Head of Segment Marketing Vaccines, at Sartorius Stedim Biotech

The implementation and use of single-use system (SUS) in biopharmaceutical production is rapidly increasing and directly correlated with higher demands on Extractables and Leachables (E&L) information. Sartorius as a leader in SUS technology can look back on +20 years of experiences in the E&L area. This knowledge together with our current research initiatives enables us to progress and go beyond “simple” extractables measurement. In this presentation, we will show how we employed our experiences to come to a deep understanding of extractables, and finally to methods to predict extractables and leachables. We will show that only an adequate physical and chemical understanding allows a correct scaling and combination of extractables data for the numerous devices and assemblies provided to the market. And we will show how a mechanistic modelling, which combines sources and sinks of leachables appropriately can be used in risk assessments to quantitatively predict leachables along a process chain.

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