The Mass Spectrometry society of Japan - The 68th Annual Conference on Mass Spectrometry, Japan
Japanese

Abstract

Table of contents

Timetable

Plenary Lectures

Award Lecture

Oral Sessions (Day1, Day2, Day3)

Poster Presentations (Day1, Day2, Day3)

Panel Discussion

Luncheon Seminars (Day1, Day2, Day3)

Corporate Program

Poster Presentations

Day 3, June 24（Fri.）　　Room P (501, 502 and 503)

3P-19　　PDF

Biosimilar Peptide Mapping Characterization and MAM Workflow Using Prototype Benchtop Q-TOF with An App-Based Acquisition and Data Processing Platform

(1Nihon Waters, 2Waters - Milford, 3Waters - Wilmslow)
oMasayuki Kubota1, Maki Terasaki1, Kenji Hirose1, Samantha Ippoliti2, Kellen Delaney2, Lisa Reid3, Owen Cornwell2, Ying Yu2, Emma Harry3, Scott Berger2

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.