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

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1716-1721
Number of pages6
JournalBiological and Pharmaceutical Bulletin
Volume41
Issue number11
DOIs
Publication statusPublished - 2018
Externally publishedYes

Keywords

  • Biosimilar
  • Glycosylation
  • Infliximab
  • Time-of-flight MS

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science

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