Simon Daniel et al., published this research article in Trends in Biotechnology Journal and explore the application of Quality by Design (QbD) principles to RNA platform production processes. It highlights the critical quality attributes (CQAs) of RNA-based products, focusing on immunogenicity and instability, and explores the complex relationship between product quality and process parameters. The article then delves into advanced analytical and modeling technologies, including process analytical technology (PAT) and digital twins, to enable the design and control of robust and versatile manufacturing processes. The authors propose a future vision for a disease-agnostic RNA platform technology that can rapidly adapt to emerging threats and variants, emphasizing the potential of QbD to unlock the full potential of RNA technology for global vaccination, infectious disease control, and future therapy development.

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