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Shimadzu Review 82[1・2] (2025)
Abstract
The use of biopharmaceuticals has been expanding rapidly due to their high therapeutic efficacy and low side effects. Consequently, the global production of biopharmaceuticals has been increasing year by year to meet the high demand. Antibody drugs are a particularly popular type of biopharmaceutical, with antibody drug consumption accounting for about 50% of the total biopharmaceuticals market1). Antibodies, which are the key ingredient in antibody drugs, are produced by culturing cells based on genetic engineering. Therefore, unlike small-molecule drugs, the manufacturing process is complicated and requires many steps. To ensure the quality of antibody drugs, culturing processes are carefully controlled by sampling and variously testing the solutions to confirm their quality. As one such test, glycan modifications attached to antibodies in the culture solution are analyzed to confirm their profile. However, the tedious and time-consuming pretreatment process required to analyze the glycans has been an issue.
This article provides an overview of the MUP-3100 fully automated sample preparation module for glycan analysis developed for contribution to the quality control and development of antibody drug culturing processes. The article also describes an example of using the MUP-3100 for analysis of N-linked glycans, which is an important quality control parameter for antibody drugs.
Lab Mechanics Business Unit, Analytical & Measuring Instruments Division, Shimadzu Corporation, Kyoto, Japan
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