连续加工用于制造抗体-药物结合物 (ADCs)
Subhankar Metya1, Pragya Prakash2, Anurag S Rathore1,2
1School of Interdisciplinary Research, Indian Institute of Technology Delhi, New Delhi 110016, India.
Bioconjugate chemistry
|February 2, 2026
概括
使用卷轴式流量逆变反应器 (CFIR) 的连续制造显著改善了抗体-药物合物 (ADC) 的生产. 与传统的批量方法相比,这种新的生物处理方法提高了效率,降低了成本.
科学领域:
- 生物制药制造业 生物制药制造业
- 化学工程是化学工程的重要组成部分.
- 药物输送系统 药物输送系统
背景情况:
- 抗体-药物结合物 (ADCs) 将单克隆抗体 (mAbs) 与细胞毒药物合并为向治疗.
- 目前的ADC制造面临诸多挑战,包括效率低下,浪费和药物对抗体比率 (DAR) 的控制.
研究的目的:
- 为ADCs开发和评估一种新的连续合过程.
- 为了提高制造效率,降低成本,提高ADC生产中的安全性.
主要方法:
- 使用卷轴式流量逆变反应器 (CFIR) 在 mAb 链间的半氨酸中进行连续的 thiol-maleimide 结合.
- 选的过程参数用于二醇的减少和结合.
- 使用实验设计 (DoE) 优化了关键参数 (mAb/药物度,持续时间,温度).
主要成果:
- 在CFIR中,生产率比传统的批量结合高了64.40%.
- 实现了70%的生产成本降低.
- 生产了具有临床相关性DAR的ADC,并提供了更安全的制造替代品.
结论:
- 使用CFIR的连续处理为ADC制造提供了一个更有效,更可扩展和更可持续的平台.
- 这种方法解决了当前ADC生产中的关键挑战,为改善生物治疗开发铺平了道路.
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