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Updated: Jul 4, 2025

Operation of the Collaborative Composite Manufacturing CCM System
Published on: October 1, 2019
通过开发和部署自主流程分析技术平台系统系统,加速以属性为中心的流程和产品开发
Chao-Hsiang Richard Wu1, Becky Chan1, Zac Sarich1
1Attribute Sciences, Process Development, Amgen Inc., Thousand Oaks, California, USA.
本研究引入了实时生物制药分析的自动化系统,加速了工艺开发并确保了产品质量. 这些创新使得制造环境中的测试和发布速度更快.
科学领域:
- 生物制药制造业 生物制药制造业
- 分析化学 分析化学
- 工艺工程是过程工程.
背景情况:
- 实时监测和控制对于生物制药制造至关重要,以确保所需的产品质量属性.
- 设计质量 (QbD) 方法需要始终提供高质量的产品的流程,但离线分析测试会导致延误.
- 加快过程开发需要部署先进的分析技术.
研究的目的:
- 开发一个自动化的,在线的,实时的生物制药样本采集和制备平台系统.
- 为了解决快速在工艺过程中监测,控制和产品释放的未满足需求.
- 为了在实验室和制造环境中实现更快的分析测试.
主要方法:
- 开发一个微序列注射过程分析仪.
- 创建一个自动测试准备平台系统.
- 这些系统的集成用于自动化样品处理和分析.
主要成果:
- 成功开发集成自动化系统,用于采集和准备样品.
- 展示系统在线实时分析的能力.
- 验证系统在实验室和良好制造实践 (GMP) 环境中部署.
结论:
- 开发的自动化系统显著加速生物制药工艺开发和产品发布.
- 这些创新通过提供实时质量见解来支持以属性为重点的设计质量方法.
- 这些系统为快速分析测试提供了多功能解决方案,提高了生物制造的效率和质量保证.
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