A blueprint for quality by digital design to support rapid RNA vaccine process development, manufacturing & supply

Abstract

The COVID-19 crisis has highlighted the critical role of vaccine manufacturing in managing infectious disease outbreaks and pandemics. Enhancing RNA manufacturing capability, distribution and flexibility will now be central in future epidemic preparedness and emergency response strategies. This insight showcases the adaptation of Quality by Design (QbD) principles to RNA vaccine platform production processes. In particular, the implementation of a digital, holistic, and RNA-specific QbD approach can revolutionize vaccine development, regulatory approval, and manufacturing. We discuss how this framework can help overcome the remaining scientific, industrial, and regulatory challenges, potentially leading to a globally distributed network of versatile and pre-approved manufacturing platforms. A new blueprint is herein proposed for the development, validation and lifecycle management of these platform processes.