BRIEFING

 〈1060〉 Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins. This new general chapter is intended to provide users with principles and practical guidance regarding the LC-MS-based peptide mapping approach of the multi-attribute method (MAM) for therapeutic proteins. The chapter details sample preparation, system readiness, general considerations, and case studies for MAM. Guidance for assay validation and method transfer is provided. In addition to the peptide mapping MAM approach, intact and subunit-level LC-MS analysis and use of MAM in process analytical technology (PAT) is addressed briefly at the end of the chapter.

 (BIO2: J. Sun)

 Correspondence Number—C322305