Biological and Pharmaceutical Bulletin

Featured article

Volume 41 (2018) Issue 11 Pages 1716-1721

Analysis of Glycoforms and Amino Acids in Infliximab and a Biosimilar Product Using New Method with LC/TOF-MS

Masahiro Tsuda, Yuki Otani, Atsushi Yonezawa, Sho Masui, Yasuaki Ikemi, Masaya Denda, Yuki Sato, Shunsaku Nakagawa, Tomohiro Omura, Satoshi Imai, Takayuki Nakagawa, Makoto Hayakari, Kazuo Matsubara

Biosimilar products of therapeutic antibodies have been launched all over the world. They can relieve some of the economic burden of medicines. Although clinical trials have demonstrated the equivalency of biosimilar products with their reference product, biosimilar products are not commonly used in clinical practice. One reason is that the structural difference between the reference product and a biosimilar one remains unclear. We analyzed glycoforms and amino acids of an infliximab biosimilar product approved in Japan compared to that of the reference product (Remicade^®). By combination of papain digestion and LC/ time-of-flight (TOF)-MS, we established a valuable method to analyze these therapeutic antibodies. Nine glycoforms were detected in infliximab, and a difference in amino acids was observed. In the glycoforms of MMF, MGnF/GnMF, GnGn, GnGnF, AGnF/GnAF, and AAF, the relative intensities were significantly different between the reference and biosimilar product. Furthermore, we elucidated that the content rate of the C-terminal lysine was different among glycoforms. In conclusion, our analytical method can analyze not only amino acids but also carbohydrate chains of therapeutic antibodies, and will provide a useful strategy to evaluate bio-medicines including biosimilar antibodies.

Editor’s picks

How can you know the structural difference between biosimilar and reference product? The structure of biosimilar products is not the same as their original product because of post-translational modifications. In the article by Tsuda et al., a valuable method with a papain digestion and LC/TOF-MS analysis was established. Their new method can analyze not only carbohydrate chains but also amino acids of bio-medicines including biosimilar antibodies. This technology will provide a useful strategy to evaluate bio-medicines including biosimilar antibodies.

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2018 Volume 41 Issue 11

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Deterioration of Glycemic Control Contributes to the Prevalence of Proteinuria among Bevacizumab-Treated Cancer Patients with Type 2 Diabetes Mellitus Takeshi Chiba, Satoru Nihei, Hideaki Komatsu, Mami Obara, Yasushi Ishigaki, Akira Sasaki, Kenzo Kudo
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UPLC/MS-Based Metabolomics Investigation of the Protective Effect of Hydrogen Gas Inhalation on Mice with Calcium Oxalate-Induced Renal Injury Hongtao Lu, Jiarong Ding, Wenrui Liu, Zhongjiang Peng, Wei Chen, Xuejun Sun, Zhiyong Guo

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