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Updated: Feb 20, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

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再結合モノクローナル抗体バイオシミラーの分析および機能的生物類似性評価を行うためのベストプラクティス

Anurag S Rathore1,2, Raj Suryanarayanan3,4, Reza Nejadnik3,5

  • 1Department of Chemical Engineering, Indian Institute of Technology, Hauz Khas, Delhi, New Delhi, 110016, India. asrathore@biotechcmz.com.

The AAPS journal
|February 18, 2026
PubMed
まとめ

バイオシミラー薬は,副作用が少ない効果的な治療法を提供しますが,高価です. モノクローナル抗体 (mAbs) の生物類似性を実証するには,特に補助物質に関する分析上の課題があり,安定性と評価結果に影響を与えます.

キーワード:
生物類似性評価についてバイオシミラーとはキャラクタライゼーションエキシピエント 補助成分モノクローナル抗体について安定性の安定性とは

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