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NIIMBL Releases the First Industry-wide Biomanufacturing Readiness Level Framework for Biologics

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.

The BRL framework, described in the Biotechnology and Bioengineering journal, will benefit technology innovators, developers, and adopters with the ability to assess the maturity level of technology implementation during the clinical trials and commercial scale manufacturing processes that will allow them to overcome technology adoption hurdles from inception to commercialization. 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.

"Collaboration is key to innovation and this framework will further strengthen collaboration across the network of technology inventors to adopters and help create novel technologies impacting high-value biopharmaceutical products," said lead author Sandeep Kedia, NIIMBL Senior Technology Fellow. "We often hear from technology developers that the anticipated BRL is inconsistent with the maturity levels identified for their technology adoption by a different entity. This process eliminates the inconsistency and allows developers to focus on what is needed to truly advance technology to the next BRL effectively."

"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. "Sharing a common framework across all industry is key to navigating and identifying readiness levels to help get technology to the finish line faster to ultimately benefit patients."

Released October 3, 2022