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Biomanufacturing Readiness Levels (BRL) – A Shared Vocabulary for Biomanufacturing Technology Development and Commercialization

Published

Author(s)

John E. Schiel, Kelley Rogers, Sandeep Kedia, Jeffery Baker, Ruben Carbonell, Kelvin Lee, Christopher Roberts, John Erickson, Gene Schaefer, Stephanie Pluschkell

Abstract

The Manufacturing Readiness Levels (MRLs) developed by the Department of Defense (DoD), are well established tools for describing the maturity of new technologies resulting from government sponsored Research and Development (R&D) 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 biopharmaceutical manufacturing. This paper describes Biomanufacturing Readiness Levels (BRLs) developed by NIIMBL (the National Institute for Innovation in Manufacturing Biopharmaceuticals), a public/private partnership that is part of the Manufacturing USA network. NIIMBL brings together private, Federal, non-profit, and academic stakeholders to accelerate the deployment of innovative technologies for biopharmaceutical production and to educate and train a world-leading biopharmaceutical manufacturing workforce. We anticipate that these BRLs will lay the groundwork for a shared vocabulary for assessment of technology maturity and readiness for commercial biopharmaceutical manufacturing that effectively meets the needs of this critical, specialized, and highly regulated industry.
Citation
Biotechnology and Bioengineering

Keywords

Biopharmaceutical, Biomanufacturing

Citation

Schiel, J. , Rogers, K. , Kedia, S. , Baker, J. , Carbonell, R. , Lee, K. , Roberts, C. , Erickson, J. , Schaefer, G. and Pluschkell, S. (2022), Biomanufacturing Readiness Levels (BRL) – A Shared Vocabulary for Biomanufacturing Technology Development and Commercialization, Biotechnology and Bioengineering (Accessed February 29, 2024)
Created September 6, 2022, Updated January 26, 2023