NIIMBL Releases the First Industry-wide Biomanufacturing Readiness Level Framework for Biologics
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Thursday, September 29, 2022
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NEWARK, Del., Sept. 29, 2022 /PRNewswire/ -- The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announces a Biomanufacturing Readiness Levels (BRLs) framework to lay the groundwork for a universal assessment of technology maturity and readiness level for commercial biomanufacturing technology adoption.
Key Points:
- NEWARK, Del., Sept. 29, 2022 /PRNewswire/ -- The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announces a Biomanufacturing Readiness Levels (BRLs) framework to lay the groundwork for a universal assessment of technology maturity and readiness level for commercial biomanufacturing technology adoption.
- Modeled after the successful Manufacturing Readiness Levels developed by the Department of Defense, BRLs provide a tailored approach to the technology adoption journey that is specific to the biopharmaceutical industry.
- "The new BRL definitions integrate concepts of technology readiness, manufacturing readiness, quality readiness, and operational readiness to guide biotechnology developers toward innovations that are ready for implementation in commercial biomanufacturing," said Kelley Rogers, Technical Program Manager at the National Institute of Standards and Technology.
- NIIMBL's BRL outline each readiness level and best practices for classifying the status of a new manufacturing technology and provide examples for technology adoption during manufacturing of biopharmaceuticals.