Process modeling in the CMC of vaccines: are we doing it right?

Vaccine Insights 2022; 1(5), 299–314

DOI: 10.18609/vac.2022.042

Published: 28 November 2022
Harini Narayanan, Christopher Love

With a wider variety of vaccine platforms becoming available, manufacturers need more efficient ways to perform CMC. Machine learning and artificial intelligence hold the potential to reduce the time and cost associated with process modeling and data analysis in CMC workflows. However, we believe that significant changes in data collection and experimental approaches are needed, as historical datasets are insufficient to realize the full potential of these models. This article discusses some key challenges and offers practical solutions to incorporate machine learning and artificial intelligence into vaccine CMC.