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The Power of Proper System Suitability Tests - A Case Study of cGMP Method Improvement

‐ Apr 21, 2021 10:55am

System suitability assessment is an essential part of bioassay methods. The choice of system suitability parameters and their ranges is critical for ensuring the quality of bioassay results. In this talk, we share a case study of successful bioassay method remediation, which significantly improved a legacy commercial method by replacing inappropriate system suitability criteria with state of the art new criteria. The talk provides an overview of the legacy method investigation, as well as determination, justification and implementation of the new system suitability criteria.

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