A Digital Paradigm for mRNA Vaccine Development

Despite the advances and increased usage of process analytical technology (PAT) in biomanufacturing pipelines, current industry practices for bioprocess development and characterization have yet to suitably integrate the vast amounts of data that is generated from these tools. With new modalities such as mRNA vaccines becoming crucial tools that have proven their potential to target global health issues rapidly and effectively, it is imperative that we develop our bioprocessing platforms to allow for fast development, prototyping, and deployment of new products. Integrating a model-based strategy within current workflows may reduce the number of experiments needed to characterize these processes, thus reducing timelines while simultaneously improving product quality. In this talk, we discuss our efforts on this front, primarily focusing on our efforts within the space of mRNA therapeutics to integrate digital twins within our bioprocess development pipelines within Pfizer. We discuss our multimodal efforts using machine learning and mechanistic modeling to move towards a Pharma 4.0 paradigm and reflect on current and future industry practices that we believe may enable a rapid transformation within this space.