November 30, 2023 | News & Notices Providing a New Tool for Developing Manufacturing Processes for Antibody Pharmaceuticals
Commercialization of an Efficient Method for Analyzing Sugar Chain Structures

Product Photo: LCMS-8060NX Triple Quadrupole Liquid Chromatograph Mass Spectrometer

Product Photo: LCMS-8060NX Triple Quadrupole Liquid Chromatograph Mass Spectrometer


Shimadzu Corporation has begun providing new products for pharmaceutical companies and contract development and manufacturing organizations (CDMO) for use in developing manufacturing processes for antibody pharmaceuticals. As the first stage, we have released LC/MS/MS Method Package for Sugars and Sugar Nucleotides for triple quadrupole liquid chromatograph mass spectrometers (LCMS). This software analyzes sugars and their intermediates, sugar nucleotides, which form the substrate for sugar chains (linked sugar compounds). These are important determiners of the quality of antibody pharmaceuticals, and are found within cells and the culture solutions of antibody producing cells. The software includes analytical conditions for 25 sugars, 9 sugar nucleotides (sugar chain precursors), and related compounds, and requires no particular preparation before use. It is assumed that the software will be used in process development applications, to optimize and heighten the efficiency of the antibody pharmaceutical manufacturing process. Shimadzu provides a variety of products and software programs including this one, as total solutions contributing to heightening the efficiency of cellular culture conditions in antibody pharmaceutical manufacturing.

Antibody pharmaceuticals are manufactured utilizing Chinese hamster ovary. Targeting antigens that mark cancer cells is expected to heighten therapeutic outcomes and reduce side effects. The structures of sugar chains, which play an important role in this, are very complicated and diverse. In recent years, initiatives to control sugar chain structure by adjusting the culture media components during manufacturing have been reported. However, techniques that can be implemented efficiently have never been marketed.

This software uses LCMS to analyze the sugars in the supernatant (supernatant fluid) produced after cultivation of the antibody producing cells in the culture medium. It analyzes the types and the increased/decreased amounts of sugar chains added to the culture medium, and the sugar nucleotides produced within the cells, enabling visualization of the correlation between antibodies and sugar chain structure. Some sugar chains are difficult to analyze because there are many substances with similar structures. In a world’s first, we have established the optimal sugar chain analytical conditions, enabling detailed analyses. In addition to this software, Shimadzu also provides ICP mass spectrometers for analyzing metallic elements involved in sugar chain synthesis, and liquid chromatographs (LC) for analyzing the components of sugar chains attached to antibodies, thereby clarifying the relationship between culture media components and antibody sugar chain structures.Heightening the efficiency of searches for cultivation conditions to control sugar chain structure is a revolutionary contribution to the antibody pharmaceutical development process.

Shimadzu is focused on cell-related business activities, and has the LC/MS/MS Method Package for Cell Culture Profiling and other software packages to assist in the optimization of cell culture conditions. Based on the analytical results obtained from this software and Cell Culture Profiling, Shimadzu Diagnostics Corporation, a development, manufacturing, and sales subsidiary in the clinical sector is expanding its development and sale of customized culture media.


1. The World’s First Software Optimized for Sugar Analysis

Many so-called isomers of sugars and sugar nucleotides exist with the same weight and similar structures, making analysis and identification difficult. This software is equipped with the optimal analytical conditions for sugar and sugar nucleotide isomers. This is the first software in the world that enables analysis to start simply, without investigating troublesome conditions.

2. Visualization of Correlations in the Metabolic Pathways

This software package includes a blank map for the multi-omics analysis package, which can help in visualizing the type and increase/decrease of sugars added to culture media as well as sugar nucleotides metabolized and produced within cells. Changes in the time series in accordance with cultivation can be easily confirmed, enabling efficient searches for cultivation conditions for controlling sugar chain structure.

Window of the Blank Map for the Multi-Omics Analysis Package
Window of the Blank Map for the Multi-Omics Analysis Package

3. Providing Total Solutions for Manufacturing Antibody Pharmaceuticals

Using LC to analyze the sugar chain components ultimately manufactured, and comparing the results with the analysis results from this software makes it possible to search for cultivation conditions that control sugar chain structures. Shimadzu provides total solutions for antibody pharmaceutical manufacturers by combining software contributing to optimizing cell culture conditions with customization of culture media utilizing Cell Culture Profiling.

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LCMS-8060NX Triple Quadrupole Liquid Chromatograph Mass Spectrometer