Vaccine process technology—A decade of progress
Date
2024-05-06
Journal Title
Journal ISSN
Volume Title
Publisher
Biotechnology and Bioengineering
Abstract
In the past decade, new approaches to the discovery and development of vaccines have transformed the field. Advances during the COVID-19 pandemic allowed the production of billions of vaccine doses per year using novel platforms such as messenger RNA and viral vectors. Improvements in the analytical toolbox, equipment, and bioprocess technology have made it possible to achieve both unprecedented speed in vaccine development and scale of vaccine manufacturing. Macromolecular structure-function characterization technologies, combined with improved modeling and data analysis, enable quantitative evaluation of vaccine formulations at single-particle resolution and guided design of vaccine drug substances and drug products. These advances play a major role in precise assessment of critical quality attributes of vaccines delivered by newer platforms. Innovations in label-free and immunoassay technologies aid in the characterization of antigenic sites and the development of robust in vitro potency assays. These methods, along with molecular techniques such as next-generation sequencing, will accelerate characterization and release of vaccines delivered by all platforms. Process analytical technologies for real-time monitoring and optimization of process steps enable the implementation of quality-by-design principles and faster release of vaccine products. In the next decade, the field of vaccine discovery and development will continue to advance, bringing together new technologies, methods, and platforms to improve human health.
Description
This article was originally published in Biotechnology and Bioengineering. The version of record is available at: https://doi.org/10.1002/bit.28703. © 2024 The Authors. Biotechnology and Bioengineering published by Wiley Periodicals LLC. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Keywords
analytics, cell culture, lipid nanoparticle, manufacturing, mRNA, vaccine characterization
Citation
Buckland, B., Sanyal, G., Ranheim, T., Pollard, D., Searles, J. A., Behrens, S., Pluschkell, S., Josefsberg, J., & Roberts, C. J. (2024). Vaccine process technology—A decade of progress. Biotechnology and Bioengineering, 1–32. https://doi.org/10.1002/bit.28703