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.

View the past featured articles

2018 Volume 41 Issue 11

Echinacoside, an Active Constituent of Cistanche Herba, Exerts a Neuroprotective Effect in a Kainic Acid Rat Model by Inhibiting Inflammatory Processes and Activating the Akt/GSK3β Pathway Cheng Wei Lu, Hsi Lung Hsieh, Tzu Yu Lin, Ting Yang Hsieh, Shu Kuei Huang, Su Jane Wang
Quality Testing of Tacrolimus Ointment Mixed with Various Type of Ointments or Creams Takahisa Nakane, Hirohisa Doi, Masayoshi Hirohara, Hajime Hamashima, Yoshihiro Inoue
Ginsenoside Rg1 Protects against Non-alcoholic Fatty Liver Disease by Ameliorating Lipid Peroxidation, Endoplasmic Reticulum Stress, and Inflammasome Activation Yashu Xu, Cheng Yang, Shujun Zhang, Jiajun Li, Qing Xiao, Wenxiang Huang
Risk Factors for Eye Disorders Caused by Paclitaxel: A Retrospective Study Yusuke Noguchi, Yugo Kawashima, Megumi Maruyama, Hiroko Kawara, Yoko Tokuyama, Kiyoshi Uchiyama, Yoshihiro Shimizu

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