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单克隆抗体聚合物的对效应器功能表征的影响

Wendy J Walton¹, Shousong Jason Zhang¹, Joseph J Wilson¹

¹Bioproduct Research & Development, Lilly Research Laboratories, Lilly Technology Center North, Indianapolis, IN 46221, USA.

Antibodies (Basel, Switzerland)

|April 23, 2025

概括

单克隆抗体聚合显著影响Fc玛受体 (FcγR) 结合,特别是FcγRIIa,在基于贪的测试中. 即使是较低的聚合水平也会大大增加FcγRII的结合,这凸显了控制抗体聚合的重要性.

科学领域:

生物制药的发展.
免疫学免疫学免疫学
蛋白质聚合蛋白质的聚合.

背景情况:

治疗性单克隆抗体,通常是IgG1,利用Fc玛受体 (FcγR) 相互作用来实现效应器功能.
控制抗体聚合物对于治疗疗效和安全至关重要.
关于抗体聚合对FcγR结合的影响的先前研究主要使用了基于激情的格式的表面等离子体共振 (SPR).

研究的目的:

为了研究哪个Fc玛受体 (FcγR) 是最受单克隆抗体 (mAb) 聚合影响的.
为了确定mAb聚合物如何影响FcγR结合在基于溶液和基于细胞的测试中.
为了比较FcγR与mAb结合的聚合物在不同的测试格式中.

主要方法:

强制降解和IgG1单克隆抗体 (mAb1) 的尺寸排除色谱,以丰富聚合物.
在各种格式和基于溶液的测定中使用表面等离子体共振 (SPR) 对mAb1聚合物的FcγR结合的评估.
使用基于FcγR记者细胞的测定来评估FcγR结合.

主要成果:

所有测试的Fcγ受体在基于的SPR和溶液测定中都显示出对mAb1聚合物的结合增加,其中FcγRIIa受到影响最大.
结合mAb1聚合物的FcγRIIa在抗体降低SPR格式中没有增加,SPR格式对欲效应的敏感性较小.
mAb1的总活性在FcγRIIa基于细胞的试验中略有增加,但在FcγRIIIa试验中下降,可能是由于fucosylation的差异.

结论:

单克隆抗体聚合显著影响FcγR结合,特别是在基于贪的格式中.
即使在抗体聚合水平较低的情况下,也观察到FcγRII结合的增加.
了解这些相互作用对于治疗抗体的开发和质量控制至关重要.

关键词:

这是一个Fc受体.聚合方式聚合方式聚合方式这是一个有约束力的约束.强制降解降解的强制性降解这是一种单克隆抗体.表面的等离子体共振.

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