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Biomanufacturing Readiness Levels (BRLs) Framework

NIIMBL has published the Biomanufacturing Readiness Levels (BRLs) framework for the biomanufacturing community to support and accelerate the adoption of advanced manufacturing technologies.

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.  

What are BRLs?

  • Provide a common approach for technology innovators, developers, and adopters for assessing the maturity level of technology in clinical trials and commercial-scale manufacturing processes 
  • 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
  • Help classify the status of a new manufacturing technology throughout the development lifecycle, for which the intended end use is the application of the technology toward the production of a licensed biologic medicine
Sample pages from the BRL Assessment Tool website

BRL assessment tools

  • NIIMBL’s BRL assessment tools lay the groundwork for a shared vocabulary for the assessment of technology maturity and readiness for the commercial biomanufacturing industry.  
  • The BRLs 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. 

Quick Assessment

  • Short baselining assessment designed to give you a high-level overview of the status of your technology at each readiness level
  • Takes only a few minutes to complete

Detailed Self-Assessment

  • More complete assessment designed to validate your technology status and/or get additional detail about the requirements of each level
  • Takes approximately two hours to complete (you can save progress and continue at your convenience)

Additional resources

BRL benefits

  • Identify risks and perform gap analysis for specific technologies to improve development and adoption plans
  • Show progress over time
  • Manage a portfolio of technology projects
  • Provide a toolkit for sharing a common vocabulary and quality risk management plans

Become a member

We offer a variety of membership options that give you the flexibility to choose your organization’s level of engagement based on technology interests and priorities.