National Institute of Innovation in Manufacturing Biopharmaceuticals, Newark, Delaware, USA.
Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology, Rockville, Maryland, USA.
Biotechnol Bioeng. 2022 Dec;119(12):3526-3536. doi: 10.1002/bit.28227. Epub 2022 Sep 21.
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.
美国国防部制定的制造准备级别（MRL）是描述政府资助的研究与开发计划所产生的新技术成熟度的成熟工具，从概念阶段到商业部署。虽然 MRL 通常适用于广泛的行业和技术，但提供特定于行业的视角来了解基本原理如何应用于生物制造具有重要价值。本文介绍了由国家创新制造生物制药研究所（NIIMBL）开发的生物制造准备级别（BRL），这是美国制造网络的一部分，是公私合作伙伴关系。NIIMBL 将私营、联邦、非营利和学术利益相关者聚集在一起，以加速创新技术在生物制药生产中的部署，并教育和培训世界领先的生物制造劳动力。我们预计，这些 BRL 将为评估技术成熟度和商业生物制造准备情况奠定基础，从而有效地满足这个关键、专业化和高度监管行业的需求。
