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<p>Recombinant monoclonal antibody (mAb) therapeutics exhibit lot-to-lot glycosylation variation influenced by manufacturing processes, which remains underexplored publicly. This study analyzed five years of trastuzumab and adalimumab lots, revealing up to 4% range of variation in glycan relative abundance and significant change or drift of ~1% by ANOVA, levels unlikely to affect mAb efficacy or safety. The results suggest that modern manufacturing can maintain consistent glycan profiles within realistically achievable ranges.</p>

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On the achievable consistency of glycan distribution in biomanufacturing of therapeutic mAbs

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月6日

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  • Hongbin Zhu,
  • Joshua Shipman,
  • Weiming Ouyang,
  • Kang Chen

摘要

Recombinant monoclonal antibody (mAb) therapeutics exhibit lot-to-lot glycosylation variation influenced by manufacturing processes, which remains underexplored publicly. This study analyzed five years of trastuzumab and adalimumab lots, revealing up to 4% range of variation in glycan relative abundance and significant change or drift of ~1% by ANOVA, levels unlikely to affect mAb efficacy or safety. The results suggest that modern manufacturing can maintain consistent glycan profiles within realistically achievable ranges.