开创JIT战略,加速生物连续制造的拉曼方法开发和实施
Hanzhou Feng1, Zachary D Dunn1, Roli Kargupta2
1Data Rich Measurements, Analytical Research and Development, Merck & Co., Inc., Rahway, New Jersey 07065, United States.
Analytical chemistry
|February 7, 2024
概括
一个新的即时策略 (JIT) 加快了用于单克隆抗体 (mAb) 生产的拉曼光谱模型开发. 这种方法可以实时监测和控制加速的生物制造工艺.
科学领域:
- 过程分析技术 (PAT) 是一种分析技术.
- 生物制药制造业 生物制药制造业
- 化学测量 化学测量 化学测量
背景情况:
- 拉曼光谱是监测单克隆抗体 (mAb) 生产的关键过程分析技术 (PAT).
- 传统的化学测量模型开发需要大量的数据,这在加速药物开发时间表方面具有挑战性.
- 缩短的时间表限制了生物处理中的拉曼应用数据收集窗口.
研究的目的:
- 为快速开发拉曼模型引入和验证一个即时 (JIT) 策略.
- 为了减少在mAb制造中实施拉曼光谱的时间和数据要求.
- 确保拉曼光谱在加速生物制剂开发中的有效应用.
主要方法:
- 拉曼光谱与在线二维液态染色学 (2D-LC) 作为PAT系统的整合.
- 使用拉曼数据对抗体标位和总百分比进行实时化学测量建模.
- 拉曼模型的动态更新与新获取的过程数据.
- 将JIT战略应用于连续生物制造工艺.
主要成果:
- 使用实验室规模批次的有限数据建立了充分的初始拉曼模型.
- 在规模化批次中,模型在实时更新成功,证明了适应性.
- 联合实验室的战略有效地加速了用于过程监测的拉曼方法的发展.
- 概念验证研究证实了 JIT 对加速生物处理的可行性.
结论:
- 正在时间 (JIT) 策略显著减少了mAb制造的拉曼模型开发时间.
- 这种方法支持实时监测和控制加速的生物过程.
- 联合实验室的战略使得PAT工具在制药开发中的实施速度更快,与行业需求保持一致.
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