端到端的数字双胞胎软件用于连续的mRNA制造
Mohammed Aatif Shahab1, Nathan Merica Stover1, Hasan Al-Mahayni1
1Department of Chemical Engineering, Massachusetts Institute of Technology, 77 Massachusetts Ave, Cambridge, MA, 02139, USA.
International journal of pharmaceutics
|October 24, 2025
概括
一个新的数字双胞胎软件通过模拟关键的生产步骤,使信使RNA (mRNA) 疗法的连续制造成为可能. 这加快了流程优化,并支持可扩展,可靠,数据驱动的生产,以满足全球卫生需求.
科学领域:
- 生物技术是生物技术.
- 制药制造业 制药制造业 制药制造业
- 计算机建模 计算建模
背景情况:
- 使者RNA (mRNA) 疗法提供了快速开发和广泛的应用,但面临着与传统批量工艺的制造可扩展性和一致性问题.
- 连续制造为提高mRNA生产效率和可靠性提供了一个有希望的替代方案.
研究的目的:
- 开发和展示一种新的数字双胞胎软件,用于端到端连续制造mRNA疗法.
- 将关键单元操作集成到一个模块化,用户友好的平台,用于过程模拟和优化.
主要方法:
- 该软件集成了体外转录 (IVT),触流过 (TFF),连续染色学 (CCTC),脂质纳米粒子 (LNP) 配方和冷干燥模块.
- 图形界面允许工程师在没有编码的情况下操纵模块,由机械模型和数据存储数据库支持.
- 基于莫里斯的全球灵敏度分析用于流程优化和模型验证.
主要成果:
- 该软件成功地模拟了所有五个单元的操作,在一个代表性的mRNA生产场景中进行了模拟.
- 生成的时间序列和3D图为流程动态和产品特性提供了洞察力.
- 灵敏度分析确定了流程优化关键输入因素.
结论:
- 数字双胞胎软件加速了过程优化,并促进了mRNA制造的质量设计 (QbD) 原则.
- 它为闭环控制和操作员培训提供了一个平台,支持数据驱动的连续制造.
- 这项技术提高了mRNA疗法生产的可扩展性,可靠性和响应性.
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