Measurement of sialic acid content is insufficient to assess bioactivity of recombinant human erythropoietin

Shigehiro Yanagihara, Yuya Taniguchi, Mareto Hosono, Eiji Yoshioka, Rika Ishikawa, Yoshihiro Shimada, Toshihiko Kadoya, Kazuhiro Kutsukake

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Assessment of biological potency and its comparison with clinical effects are important in the quality control of therapeutic glycoproteins. Animal models are usually used for evaluating bioactivity of these compounds. However, alternative methods are required to simplify the bioassay and avoid ethical issues associated with animal studies. Negatively charged sialic acid residues are known to be critical for in vivo bioactivity of recombinant human erythropoietin (rhEPO). In this study, we used capillary zone electrophoresis, a chargebased separation method, to estimate the sialic acid content for predicting in vivo bioactivity of rhEPO. In vivo bioactivities of rhEPO subfractions were measured and compared with sialylation levels. The results obtained indicated that in vivo bioactivity of rhEPO is not simply correlated with the sialylation level, which suggests that it is difficult to predict biological potency from the sialic acid content alone. N-Glycan moieties as well as sialic acid residues may have a significant impact on in vivo bioactivity of rhEPO.

Original languageEnglish
Pages (from-to)1596-1599
Number of pages4
JournalBiological and Pharmaceutical Bulletin
Volume33
Issue number9
DOIs
Publication statusPublished - Oct 11 2010

Keywords

  • Bioactivity
  • Glycoprotein
  • Quality control
  • Recombinant human erythropoietin
  • Sialic acid

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science

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  • Cite this

    Yanagihara, S., Taniguchi, Y., Hosono, M., Yoshioka, E., Ishikawa, R., Shimada, Y., Kadoya, T., & Kutsukake, K. (2010). Measurement of sialic acid content is insufficient to assess bioactivity of recombinant human erythropoietin. Biological and Pharmaceutical Bulletin, 33(9), 1596-1599. https://doi.org/10.1248/bpb.33.1596