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治療用抗体の開発では、抗体候補を最適化し、臨床実験を成功にするために、半減期評価とin vitroでの機能検証という2つの要素が不可欠です。
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前臨床段階の焦点は、治療用抗体が生体内での安定性を最適化することです。半減期を延ばすと、有効性が高まり、治療頻度が減り、コストも削減されます。これらの効果を最大化するために、開発者は標的特異性を確認した後、抗体の要望な候補を改良しながら安定性を向上させます。
新生児 Fc 受容体 (FcRn) に対する Fc フラグメントの親和性は、抗体の半減期を決定する重要な要素です。FcRn 結合を分析することによって、抗体の生体内での薬物動態が予測でき、半減期の最適化が可能になります。
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Application Case: FcRn Binding Affinity Verification for Herceptin®
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Immobilized Biotinylated Human FCGRT&B2M Heterodimer Protein, His,Avitag (Cat. No. FCM-H82W7) on SA Chip can bind Herceptin® with an affinity constant of 0.267 μM
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In Vitroでの機能検証
治療用抗体の有効性は、Fab フラグメントが腫瘍関連抗原に結合する能力のほか、Fc フラグメントと Fc 受容体との相互作用によって決まります。抗体依存性細胞傷害 (ADCC)、補体依存性細胞傷害 (CDC)、抗体依存性細胞貪食 (ADCP) などの Fc 媒介エフェクター機能は、腫瘍細胞の除去または抑制に重要な役割を果たします。
したがって、治療用抗体の ADCC/ADCP 効果を評価することは、抗体医薬品の安全性と有効性を確保するために非常に重要です。
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Application Cases: ADCC Activity Evaluation
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Human CD16a (158V) (Luc) Jurkat Reporter Cell (Cat.No. SCJUR-STF067)
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ADCC response to anti-human CD20 antibody (RLU).
Anti-human CD20 antibody-induced ADCC activity was evaluated using Human CD16a (158V) (Luc) Jurkat Reporter Cell in the presence of Raji cells that express CD20 endogenously. The EC50 of anti-human CD20 antibody was approximately 0.0028 μg/mL.
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Application Cases: ADCP Activity Evaluation
Human CD32a (131H) (Luc) Jurkat Reporter Cell Development Service (Cat.No. SCJUR-STF069)
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ADCP response to anti-human CD20 antibody (RLU).
Anti-human CD20 antibody-induced ADCP activity was evaluated using Human CD32a (131H) (Luc) Jurkat Reporter Cell in the presence of Raji cells that express CD20 endogenously. The EC50 was approximately 0.1054 μg/mL.
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