Biomanufacturing readiness levels—A shared vocabulary for biopharmaceutical technology development and commercialization
| Author(s) | Kedia, Sandeep B. | |
| Author(s) | Baker, Jeffrey C. | |
| Author(s) | Carbonell, Ruben G. | |
| Author(s) | Lee, Kelvin H. | |
| Author(s) | Roberts, Christopher J. | |
| Author(s) | Erickson, John | |
| Author(s) | Schiel, John E. | |
| Author(s) | Rogers, Kelley | |
| Author(s) | Schaefer, Gene | |
| Author(s) | Pluschkell, Stefanie | |
| Date Accessioned | 2022-09-21T19:15:20Z | |
| Date Available | 2022-09-21T19:15:20Z | |
| Publication Date | 2022-09-07 | |
| Description | This article was originally published in Biotechnology and Bioengineering. The version of record is available at: https://doi.org/10.1002/bit.28227 | en_US |
| 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. | en_US |
| Sponsor | This study was supported in part by the National Institute of Standards and Technology through 70NANB17H002, 70NANB21H085, and 70NANB21H086. | en_US |
| 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 | en_US |
| ISSN | 1097-0290 | |
| URL | https://udspace.udel.edu/handle/19716/31398 | |
| Language | en_US | en_US |
| Publisher | Biotechnology and Bioengineering | en_US |
| Keywords | biomanufacturing readiness level | en_US |
| Keywords | biopharmaceutical development and commercialization | en_US |
| Keywords | manufacturing readiness level | en_US |
| Keywords | technology adoption | en_US |
| Keywords | technology readiness level | en_US |
| Title | Biomanufacturing readiness levels—A shared vocabulary for biopharmaceutical technology development and commercialization | en_US |
| Type | Article | en_US |
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