BRL
Concept Development
BRL 1
Criteria Met
Technical Readiness
Technology (unmet need)
Question 0:
Comment:
Technology (unmet need)
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Name of previous project
BRL 1
Criteria Met
BRL Results
Concept Development
BRL 1
Criteria Met
Question 0:


Answer:
Comment:
Concept Demonstration (BRL 4-7)
During this key second phase of development, the technology advances through various stages to ensure it can be implemented into clinical manufacturing settings and is ready for a quality management system (QMS). This phase is associated with pilot-scale demonstrations, or Pilot Operations (Pilot Ops) and is akin to a production-relevant environment.
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Concept Realization (BRL 8-9)
This final phase involves the implementation of technology in a commercial setting (BRL 8), and for routine deployment for other commercial approved biologics drug products (BRL 9). This phase is in the final commercial realm, or Commercial Operations (Commercial Ops), and is akin to a production-representative environment.
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Congratulations, you have completed your NIIMBL BRL assessment!

This is a valuable report that can assist you in determining next steps in advancing your technology. Your information will not be stored in our system; therefore, we strongly encourage that you save your final report as a PDF file for your records.

Note: If you are submitting this document to support a project proposal with NIIMBL, you will be required to include a PDF of this report along with supporting documentation in our submission.


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BRL RESULTS: Percentage of Criteria Met

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BRL Detailed Assessment
NIIMBL BRL Site
Welcome. Let's get started.
This framework describes Biomanufacturing Readiness Levels (BRLs) developed by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).
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. We anticipate this form will take the user approximately two hours to complete. You will be able to start and continue the assessment at your convenience, your information will be saved on your desktop to progress at a later time. Your information will not be stored in our system; therefore, we strongly encourage that you save your final report as a PDF file for your records.
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Name of this project

This tool is designed to assist you in determining the readiness level of your technology through an estimated calculation based on the criteria you have selected. This tool does not guarantee your readiness level. All reports from this tool are to be considered estimates and are subject to change. You can find additional information regarding BRL on the NIIMBL website.

Please contact BRL@NIIMBL.org for support.

Select any BRL number where you would like to begin your assessment. You can take the assessment sequentially or in any order.
Select a BRL number below to begin.
Concept Development (BRL 1-3)
In this first phase, a technology is identified to solve a biomanufacturing problem, with the goal of achieving a relevant proof-of-concept (POC) typically demonstrated in a laboratory operation (Lab Ops).
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