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Using a Microchip-based DNA analyzer “MultiNATM”
Shimadzu Review 78[3・4] (2021)
Abstract
Glycans attached to antibody therapeutics are an important quality attribute for controlling the production of antibody therapeutics. To monitor N-glycosylation in recombinant proteins, a high-throughput (HTP) methodology is required to analyze bulk samples in the manufacturing process. The MultiNA™ microchip electrophoresis system for DNA/RNA analysis is probably the only separation analysis system capable of analyzing multiple samples in a semiparallel manner and providing HTP glycan screening. In this article, we describes a microchip electrophoresis-based HTP N-glycan screening of antibody therapeutics using the MultiNA™. The developed method was also applied to analyze various antibody therapeutics. Major biantennary glycans unique to antibodies (G0F, G1F, G1F`, and G2F) as well as sialoglycans and αGal-containing glycans were successfully separated and detected, making this a promising analytical technique for implementing a Quality by Design (QbD) approach while controlling the production process using glycans as Critical Quality Attributes (CQA).
1Department of Pharmaceutical Sciences, Kindai University, 3-4-1, Kowakae, Higashi-osaka, Japan
2Global Application Development Center, Analytical & Measuring Instruments Division, Shimadzu Corporation, Kyoto, Japan
3AcroScale Inc., 468-1, Aramakiaza Aoba, Aoba-ku, Sendai, Japan
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