Biomanufacturing readiness levels—A shared vocabulary for biopharmaceutical technology development and commercialization
Date
2022-09-07
Journal Title
Journal ISSN
Volume Title
Publisher
Biotechnology and Bioengineering
Abstract
The Manufacturing Readiness Levels (MRLs) developed by the Department of Defense are well-established tools for describing the maturity of new technologies resulting from government-sponsored Research and Development programs, from the concept phase to commercial deployment. While MRLs are generally applicable to a wide range of industries and technologies, there is significant value in offering an industry-specific view on how the basic principles may be applied to biomanufacturing. This paper describes Biomanufacturing Readiness Levels (BRLs) developed by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a public/private partnership that is part of the Manufacturing USA network. NIIMBL brings together private, federal, nonprofit, and academic stakeholders to accelerate the deployment of innovative technologies for biopharmaceutical production and to educate and train a world-leading biomanufacturing workforce. We anticipate that these BRLs will lay the groundwork for a shared vocabulary for assessment of technology maturity and readiness for commercial biomanufacturing that effectively meets the needs of this critical, specialized, and highly regulated industry.
Description
This article was originally published in Biotechnology and Bioengineering. The version of record is available at: https://doi.org/10.1002/bit.28227
Keywords
biomanufacturing readiness level, biopharmaceutical development and commercialization, manufacturing readiness level, technology adoption, technology readiness level
Citation
Kedia, S. B., Baker, J. C., Carbonell, R. G., Lee, K. H., Roberts, C. J., Erickson, J., Schiel, J. E., Rogers, K., Schaefer, G., & Pluschkell, S. (2022). Biomanufacturing readiness levels—A shared vocabulary for biopharmaceutical technology development and commercialization. Biotechnology and Bioengineering, 1– 11. https://doi.org/10.1002/bit.28227