HTC-15 - Abstract

Abstract Title: Improvement in resolution and throughput on SEC analysis of monoclonal antibodies by using the new YMC-Pack Diol UHPLC column
Abstract Type: Poster
Session Choice: Comprehensive Chromatography - The State of the Art
Presenter Name: Dr Daniel Eßer
Co-authors:Mrs Mai Sato
Mrs Saoko Nozawa
Dr Masatoshi Taniguchi
Mr Takashi Sato
Dr Noritaka Kuroda
Company/Organisation: YMC Europe GmbH
Country: Germany

Abstract Information :

Antibody drugs are expected to enhance the effect of therapies without adverse side effects. During the manufacturing processes of immunoglobulin G (IgG), which is a main ingredient of antibody drugs, aggregates and fragments can be formed which may react as impurities. Size exclusion chromatography (SEC) analysis is a common method for determination of IgG characteristics as well as quality control in the production processes of IgG. YMC has developed a new SEC column with 2 µm particle size and with a Diol bonded phase, YMC-Pack Diol UHPLC.

High resolution analysis of aggregates and derived fragments can be performed with this new SEC column. Furthermore, smooth method transfer from conventional 5 μm SEC column to this new SEC column can also be achieved while reducing analysis time by using a shorter column. In this poster, we introduce the advantages of this 2 µm YMC-Pack Diol SEC column through several examples of IgG aggregates and fragments analysis.