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分析14种治疗抗体的结构,使用循环二极化光谱学
Maria G Bruque1,2, Alison Rodger3, Søren Vrønning Hoffmann4
1School of Chemical Engineering, University of Birmingham, Edgbaston B15 2TT, U.K.
Analytical chemistry
|September 10, 2024
概括
开发用于治疗单克隆抗体 (mAbs) 的新过程分析技术至关重要. 这项研究创建了一个循环二元化 (CD) 光谱的参考集,识别了pH敏感特征,用于在mAb制造过程中进行线内监测.
科学领域:
- 生物化学 生物化学
- 分析化学 分析化学
- 生物技术是生物技术.
背景情况:
- 治疗单克隆抗体 (mAb) 制造需要强大的过程分析技术 (PAT) 来确保结构完整性.
- 了解制造环境如何影响mAb结构对于药物的疗效和安全至关重要.
研究的目的:
- 为治疗 mAbs. 的循环二元化 (CD) 频谱建立一个高质量的参考集.
- 为了识别对制造引发的压力和pH值变化敏感的光谱特征.
- 探索在线基于CD监控mAb结构的潜力.
主要方法:
- 采用同步子辐射循环二元化 (SRCD) 光谱法收集高质量的远紫外和近紫外CD光谱.
- 分析了14种不同的治疗性mAbs在原生和酸压力状态.
- 进行了光谱解卷和分析,以评估二次结构赋值和识别敏感的光谱特征.
主要成果:
- 两个现有的参考集 (SP175和SMP180) 被验证为准确的mAb二次结构解卷.
- 在14mAbs的远紫外和近紫外CD光谱中观察到显著的变化.
- 在201-202nm处的远紫外线峰值和在230-240nm附近的近紫外线激电偶被确定为对pH值变化敏感.
结论:
- 开发的参考集提高了使用CD光谱的mAb结构分析的准确性.
- 确定了pH敏感的光谱特征,特别是近紫外线激电偶,显示了在生物制造过程中对mAb结构的实时,直线监测的希望.
- 这一进步支持开发更有效的PAT用于治疗性蛋白质生产.
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