Risk-Based Extractable Data Assessment and its Application to the Evaluation of Materials Used in Biomanufacturing
Posted on December 11, 2014
By: Ping Wang, Principal Scientist
Janssen R&D
Introduction In the manufacturing process of biologics, the polymeric materials have been widely used. These materials include, but are not limited to, filters, tubings, bags, O-rings, probes, gaskets, etc. Most recently, the integral single use systems (SUS) with the combination of these disposable...
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Related Topics and Keywords
analysis of leachable and extractable, biomanufacturing, e&l assessment, Extractable, extractables & leachables, gc-ms, hplc-uv-ms, icp-ms, icp-oes, Leachables, risk-based data, single-use, Single-use technologies
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