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Poster Presentations
Day 3, June 12（Wed.） Room P1 (Multipurpose Hall)・Room P2 (Conference Room 101+102)
- 3P-44
From Product Characterization to Quality Monitoring: A Single Software Platform for Automating Entire Multi-Attribute Method (MAM) Workflows
(1Genedata KK, 2Genedata)
oTsubasa Ohashi1, Arnd Brandenburg2
The Multi-attribute Method (MAM) enables the simultaneous identification, quantitation, and monitoring of critical quality attributes (CQAs) at the molecular level. A thorough product characterization through peptide mapping allows identification of product quality attributes (PQAs). After risk analysis, PQAs that have been identified as critical for product quality are monitored. Additionally, MAM approaches require new peak detection (NPD) analysis to identify unexpected quality issues. We present an innovative and highly automated data workflow approach that incorporates advanced data pre-treatment; sophisticated visualizations; flexible, highly configurable data processing workflows; and a novel automatic, logic-based review to deliver a robust and unbiased MAM solution.