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

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

Take the quick assessment

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)

Take the detailed self-assessment

Additional resources

Read the Biotechnology & Bioengineering article about BRLs

Download a summary PDF of the BRLs

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.

Join NIIMBL