Center for Biologics Evaluation and Research, US Food and Drug Administration, 10309 New Hampshire Avenue Building 52, Room 3332, Silver Spring, MD, USA.
Curr Allergy Asthma Rep. 2024 Sep;24(9):471-475. doi: 10.1007/s11882-024-01168-4. Epub 2024 Jul 24.
Allergenic extracts are often standardized to control for potency, either by measuring concentrations of major allergens or "overall allergenicity" by competition for IgE in pooled sera from highly allergic subjects with a reference extract. Recent developments present an opportunity to use human mAb cloned from highly allergic subjects to define potency of allergenic extracts.
Two recent developments present an opportunity for revising potency measurements of allergen extracts: cloning allergen specific IgE from allergic subjects and extensive epitope mapping of major allergenic proteins. Because human IgE mAb recognize biologically relevant epitopes, they present a novel opportunity to determine the potencies of allergenic extracts and may contribute to the science base for allergen standardization.
过敏原提取物通常通过测量主要过敏原的浓度或通过在高度过敏患者的混合血清中与参考提取物竞争 IgE 来“整体变应原性”来进行效价控制。最近的发展为使用从高度过敏患者中克隆的人单克隆抗体来定义过敏原提取物的效价提供了机会。
最近的两项发展为修订过敏原提取物的效价测量提供了机会：从过敏患者中克隆过敏原特异性 IgE 以及对主要变应原蛋白进行广泛的表位作图。由于人 IgE 单抗识别具有生物学意义的表位，因此为确定过敏原提取物的效价提供了新的机会，并可能为过敏原标准化的科学基础做出贡献。
