Validation of Monosaccharide Composition Assay Using HPLC-UV Platform for Monoclonal Antibody Products in Compliance with ICH Guideline

Ohseok Kwon, Il Ung Oh, Myung Jin Oh, Seung Hwa Hong, Chan Wha Kim, Hyun Joo An

Research output: Contribution to journalArticle

Abstract

Monoclonal antibodies (mAbs) are the largest class of glycosylated biopharmaceuticals. Glycans are a key functional component of mAbs, and thus their characterization is highly required during mAb developmental and regulatory phases. In particular, monosaccharides are crucial for antibody efficacy, safety, cytotoxicity, and potency, so reliable monosaccharide composition assay (MCA) is required for quality control (QC) testing. Traditional methods for MCA such as HPAE-PAD and HPLC-FLD have been suffering from low sensitivity and poor reproducibility. In this study, we developed an alternative QC method for MCA of mAb with 1-Phenyl-3-methyl-5-pyrazolone (PMP) tag products using HPLC-UV platform equipped in most QC laboratories. Four characteristics including specificity, linearity, precision, and accuracy were systemically evaluated according to ICH Q2(R1) guideline. Inter-laboratory studies were also performed to validate method reproducibility and reliability. It will be a powerful platform for QC test of not only mAb products but also Fc fusion glycoprotein products.

Original languageEnglish
Pages (from-to)1394-1399
Number of pages6
JournalBulletin of the Korean Chemical Society
Volume39
Issue number12
DOIs
Publication statusPublished - 2018 Dec 1

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Keywords

  • HPLC
  • ICH guideline
  • mAb
  • Monosaccharide composition assay
  • Validation

ASJC Scopus subject areas

  • Chemistry(all)

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