Quality by Design for enabling RNA platform production processes.

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. Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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Simon Daniel, Zoltán Kis, Cleo Kontoravdi, Nilay Shah. Quality by Design for enabling RNA platform production processes. Trends in biotechnology. 2022 Oct;40(10):1213-1228

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PMID: 35491266

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