Quality by Design for enabling RNA platform production processes

Simon Daniel; Zoltán Kis; Cleo Kontoravdi; Nilay Shah

doi:10.1016/j.tibtech.2022.03.012

Quality by Design for enabling RNA platform production processes

Trends Biotechnol. 2022 Oct;40(10):1213-1228. doi: 10.1016/j.tibtech.2022.03.012. Epub 2022 Apr 29.

Authors

Simon Daniel¹, Zoltán Kis², Cleo Kontoravdi¹, Nilay Shah³

Affiliations

¹ Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London, UK.
² Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London, UK; Department of Chemical and Biological Engineering, The University of Sheffield, Sheffield, UK. Electronic address: z.kis@sheffield.ac.uk.
³ Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London, UK. Electronic address: n.shah@imperial.ac.uk.

PMID: 35491266
DOI: 10.1016/j.tibtech.2022.03.012

Abstract

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 potential and will be central to the development, pre-qualification, and regulatory approval of rapid response, disease-agnostic RNA platform production processes.

Keywords: Quality by Design; RNA; lipid nanoparticle; process modeling.

Publication types

Review
Research Support, Non-U.S. Gov't

MeSH terms

Quality Control
RNA* / genetics
Technology, Pharmaceutical*

Substances

RNA

Grants and funding

DH_/Department of Health/United Kingdom