Quality by Design for enabling RNA platform production processes

被引：80

作者：

Daniel, Simon ^{[1
]}

Kis, Zoltan ^{[1
,2
]}

Kontoravdi, Cleo ^{[1
]}

Shah, Nilay ^{[1
]}

机构：

[1] Imperial Coll London, Fac Engn, Ctr Proc Syst Engn, Dept Chem Engn, London, England

[2] Univ Sheffield, Dept Chem & Biol Engn, Sheffield, England

来源：

TRENDS IN BIOTECHNOLOGY | 2022年 / 40卷 / 10期

基金：

英国科研创新办公室; 英国工程与自然科学研究理事会;

关键词：

MESSENGER-RNA; LIPID NANOPARTICLES; VACCINES; DELIVERY; SAFETY; SIZE;

D O I：

10.1016/j.tibtech.2022.03.012

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

RNA-based products have emerged as one of the most promising and strategic technologies for global vaccination, infectious disease control, and future therapy development. The assessment of critical quality attributes (CQAs), product-process interactions, relevant process analytical technologies, and process modeling capabilities can feed into a robust Quality by Design (QbD) framework for future development, design, and control of manufacturing processes. QbD implementation will help the RNA technology reach its full poten-tial and will be central to the development, pre-qualification, and regulatory ap-proval of rapid response, disease-agnostic RNA platform production processes.

引用

页码：1213 / 1228

页数：16

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