(550e) Hybrid Model Digital Twin Development for the Continuous Manufacturing of xRNA Vaccines and Therapeutics

The SARS-CoV-2 (COVID-19) pandemic motivated the rapid development of messenger ribonucleic acid (mRNA) vaccines and novel RNA-based therapeutic treatments. Since then, RNA-focused researchers and companies have expanded their exploration into developing new mRNA-based vaccines and exploring other potential applications of RNA-based therapeutics, including cancers, metabolic disorders, neurological diseases, and genetic diseases. Additionally, efforts have begun to enhance society's ability to respond to future pandemics and to accelerate the development and production of RNA technologies. However, RNA manufacturing faces numerous challenges, including issues related to quantity, quality, efficacy, safety, cost (largely due to RNA instability) and manufacturing deficiencies.

In response to these multifaceted challenges within the biopharmaceutical industry regarding RNA manufacturing, there is a growing recognition of the need to overcome barriers and revolutionize traditional approaches to RNA-related therapeutics manufacturing. The integration of upstream and downstream operations into a seamless continuum for continuous RNA-related vaccines and therapeutics production represents a pivotal advancement. This strategic alignment not only strengthens the resilience of the drug supply chain but also serves as a proactive measure against contamination risks, while significantly reducing time to market.

Acknowledging the paramount importance of navigating these intricate processes with precision and efficacy, industry leaders, policy makers, and regulatory bodies such as the FDA and EMA have endorsed the adoption of modeling and simulation techniques.

Within this context, our focus encompasses two key dimensions critical to the advancement of continuous RNA-related therapeutics manufacturing:

First, the application of modeling and simulation techniques to elucidate the intricacies of unit operations within the atypical continuous RNA manufacturing framework.

And second, rigorous validation of these models through comparison with experimental data, ensuring their robustness and reliability in real-world scenarios.

By delving into these foundational elements, this research seeks to propel the industry towards a future characterized by streamlined processes, enhanced efficiency, and unparalleled innovation.