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

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 charge-based 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.

journal_name

Biol Pharm Bull

authors

Yanagihara S,Taniguchi Y,Hosono M,Yoshioka E,Ishikawa R,Shimada Y,Kadoya T,Kutsukake K

doi

10.1248/bpb.33.1596

subject

Has Abstract

pub_date

2010-01-01 00:00:00

pages

1596-9

issue

9

eissn

0918-6158

issn

1347-5215

pii

JST.JSTAGE/bpb/33.1596

journal_volume

33

pub_type

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