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Full-Text Articles in Materials Science and Engineering
On The “Fate Of Leachables” In Biopharmaceutical Up-Stream And Down- Stream Processes, Armin Hauk, Ina Pahl, Roberto Menzel, Samuel Dorey, Isabelle Uettwiller
On The “Fate Of Leachables” In Biopharmaceutical Up-Stream And Down- Stream Processes, Armin Hauk, Ina Pahl, Roberto Menzel, Samuel Dorey, Isabelle Uettwiller
Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications
Single use systems (SUS), based on polymeric materials, are widely used in the biopharmaceutical manufacturing. Compounds potentially migrating from the polymeric materials into the production process at various stages as leachables can either negatively influence the production process performance (e.g. inhibit cell growth) or can contribute to process related drug impurities, which may potentially have an effect on product quality and/or patient safety. Today, the concept of investigating leachables is mainly focused on the measurement of extractables under worst case- or simulation-conditions plus their assessment including an interpolation towards potential leachables. In particular, in the frame of this assessment of …
The Journey Of A Polymer Producer To Support Customers E&L Needs, Jerome Vachon
The Journey Of A Polymer Producer To Support Customers E&L Needs, Jerome Vachon
Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications
In the view of SABIC’s ambitions to grow in the Healthcare applications market, a clear understanding of customers’ challenges and problems with respect to Extractables and Leachables is crucial. In addition to ensuring high quality products and compliance with standard regulations, material suppliers must also have a deep knowledge of their product chemistries for specific healthcare applications. Responding to our customers’ needs when performing their own material toxicological assessment, SABIC has continued to develop and share deeper insights into E&L. A growing involvement of SABIC to develop a true E&L knowledge base, from Research to Marketing, has thus been taking …