- 第3日 6月24日（金） P会場（501，502，503）
Peptide mapping is one of the gold standard techniques for post-translational modification (PTM) assessment not only for characterization, but for development and comparability, of biologics and biosimilar drugs. This rigorous characterization is crucial to ensure safety and efficacy of biopharmaceuticals. In recent years, multi-attribute method (MAM) has gained traction as a promising workflow in which digested samples (stressed or biosimilars, for example) are compared against a reference sample to assess differences or impurities among them. A successful workflow must be robust, easily implemented, and GMP-compliant. This study demonstrates the implementation of a peptide characterization and monitoring method for infliximab biosimilars on a prototype benchtop QTOF instrument with compliance-ready app-based data acquisition and processing.