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推进mRNA疫苗和治疗药物的连续封装和净化

Ehsan Nourafkan¹, Zidi Yang², Mabrouka Maamra²

¹Department of Biochemical Engineering, University College London, Marshgate Building, London E20 2AE, UK; School of Chemical, Materials and Biological Engineering, University of Sheffield, Mappin Street, Sheffield S1 3JD, UK.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

|June 27, 2025

概括

这项研究引入了传递 RNA (mRNA) 脂质纳米粒子 (LNP) 的新型连续制造工艺,提高了疫苗和治疗生产效率和可扩展性.

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
纳米技术纳米技术

背景情况:

COVID-19大流行突显了可扩展的信使RNA (mRNA) 疫苗生产的需要,揭示了供应链的局限性.
对于mRNA疗法的传统批量制造方法在效率,成本和可扩展性方面面临挑战.
连续制造在速度,成本效益和减少mRNA生产足迹方面提供了潜在的优势.

研究的目的:

开发和演示首个集成的连续制造工艺mRNA载脂质纳米粒子 (LNPs).
将实时质量控制和高效净化纳入连续mRNA-LNP生产工作流.
建立关键质量属性并评估连续制造过程的性能.

主要方法:

连续流封装mRNA到LNP.
使用空间分辨率的动态光散射实时监测颗粒大小和多分散度指数 (PDI).
单通触流过 (SP-TFF) 用于净化mRNA-LNP.

主要成果:

实现了高封装效率 (95.5 ± 4%) 和受控的颗粒大小 (105 ± 6 nm) 与低PDI (0.1 ± 0.02).
使用SP-TFF证明了高效的净化,90%的mRNA-LNP恢复,达到10X的度因子.
具有关键质量属性,包括低残留乙醇 (0.003%) 和高mRNA完整性 (86.2 ± 3%).

结论:

开发的综合连续制造工艺显著提高了mRNA-LNP生产的效率和可扩展性.
实时监测和SP-TFF净化对于确保高质量的mRNA-LNP产品至关重要.
这项基础工作为更快,更具成本效益的mRNA疫苗和疗法制造铺平了道路.

关键词:

连续制造连续制造制造脂质纳米颗粒的使用方法微流体混合的混合方式实时在线监控实时在线监控接触式流量过的过方法它们是mRNARNA.

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