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March 5, 2026Electrophoresis Letters0 citationsOpen Access

Impact of monoclonal antibody diversity on in vitro diagnostics

NKNaoyuki KozukaKYKohei YoshikawaJSJyunji Sato

Key Points

  • This research investigates the influence of post-translational modifications on monoclonal antibodies used in diagnostics.
  • Focus on N-linked glycosylation in monoclonal antibodies
  • Analysis of reactivity in latex reagents used for diagnostics
  • Comparison of different manufacturing and storage conditions
  • Identified variations in antibody reactivity due to post-translational modifications
  • Demonstrated significant effects on diagnostic performance
  • Highlighted the need for stringent quality control measures in diagnostics

Abstract

モノクローナル抗体は，研究用途から治療薬や体外診断薬などの臨床応用まで幅広く活用されている．モノクローナル抗体は単一の抗体産生細胞に由来するが，細胞培養や抗体精製といった製造工程上の要因や，保管条件などの環境要因によって，さまざまな翻訳後修飾を受けることが知られている．治療薬の分野においては，これらの修飾が生物活性や薬物動態に影響を与えることが報告されており，品質を保証するために重要品質特性の特定とその分析が重視されている．一方で，体外診断薬の分野においては，翻訳後修飾の影響に関する知見は限られている．本稿では，翻訳後修飾の一種であるn-結合型糖鎖に着目し，体外診断薬として広く使用されているラテックス試薬の反応性に及ぼす影響について紹介する．

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Cite This Study

Kozuka et al. (2026) studied this question.

synapsesocial.com/papers/69a91d21d6127c7a504bfe75https://doi.org/10.2198/electroph.70.21
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