高通量蛋白A染色体平台,用于精确量化IV添加剂中的抗体
Tse-Hong Chen1, Xiaoyang Liu1, Shao-Chun Wang1
1Formulation Development Group, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.
Analytical biochemistry
|September 20, 2025
概括
蛋白A (ProA) 亲和色谱准确量化了静脉注射混合物中的双特异抗体 (BsAbs). 这种高效的方法通过将抗体从杂质中分离出来,确保了抗体的安全性和有效性,从而支持低剂量疗法.
科学领域:
- 分析化学 分析化学
- 生物制药学分析
- 染色体学 染色体学 是一种染色学.
背景情况:
- 静脉注射 (IV) 添加剂中治疗抗体的准确量化对于患者的安全性和疗效至关重要.
- 传统的方法,如逆相液态色谱 (RPLC),难以从复杂的IV矩阵和杂质中分解抗体.
研究的目的:
- 评价蛋白A (ProA) 亲和色谱的特异性和性能,以量化IV添加剂中的双特异抗体 (BsAbs).
- 建立一个适合目的的方法,在具有挑战性的矩阵中准确量化抗体.
主要方法:
- 使用蛋白A (ProA) 亲和色谱,利用ProA与抗体Fc区域的选择性结合.
- 方法资格评估了抗体量化的线性,准确性和精度.
- 该方法应用于五种不同的BsAbs在IV添加剂矩阵中.
主要成果:
- ProA亲和色谱显示出高特异性,有效地将BsAbs与人血清白蛋白 (HSA) 和可浸出物等潜在干扰物分开.
- 精确的量化达到0.1μg/mL.
- 该方法提供了快速 (5分钟) 和完全的分离,没有样品准备,显著提高吞吐量.
结论:
- ProA亲和染色法是一种可靠,高效和特定的方法,用于量化复杂的IV添加剂中的抗体.
- 这种方法支持低剂量抗体疗法的开发和管理,通过在具有挑战性的矩阵中确保准确的测量.
关键词:
生物治疗学 生物治疗学双特异性抗体 双特异性抗体在使用中的稳定性.静脉注射的添加剂是一种混合物.矩阵干扰是对矩阵的干扰.单克隆抗体是一种单克隆抗体.蛋白质A染色体的染色学量化 量化 量化 量化更多相关视频
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