The new projects selected help expand NIIMBL's portfolio in the areas of cell and gene therapy manufacturing as well as in vaccine stabilization through manufacturing technologies among other key innovative technologies. With projects ranging from creating new purification processes that will meet a global need for high-purity, high-volume, high-dose protein therapeutics to creating a modularized extensible online training platform on leading-edge process analytical technologies (PAT) to better prepare candidates for the drastically growing workforce need in the biopharmaceutical industry, NIIMBL strategically selects projects that will help to advance technologies and workforce training for key areas of interest to our community.

"The speed of innovation has increased drastically in the last year. Our industry was challenged to push the limits and accelerate in all areas to meet the pandemic demands of the world and it delivered. We are now operating at a new level of expectation that requires delivery of treatments faster and more efficiently. One of our goals at NIIMBL is to invest in areas where the industry can save time, money and expand training to get to the finish line faster," shares Chris Roberts, Associate Institute Director.

To date, NIIMBL has now funded over 80 technical and workforce development projects with a total investment of approximately $25M since 2017 when the Institute launched. The NIIMBL community is comprised of more than 170 members from academia, industry, government and non-profit organizations all sharing a common goal to advance biopharmaceutical manufacturing.

For a description of each project and to learn more about NIIMBL, please visit the Project Call 4.1 website.

4.1 Project List

Project: A Fully Continuous Downstream Process for High Titer Products Lead: Rensselaer Polytechnic Institute Participants: AstraZeneca, ChromaTan Corporation, Janssen Research & Development, LLC., Merck, MilliporeSigma/EMD Serono, Takeda Pharmaceuticals, The Pennsylvania State University

Project: Multifunctional Microfluidic Chip for Rapid Vector Genome and Empty Capsid Quantitation in AAV Vector Production Lead: North Carolina State University Participants: Biostealth Inc., MilliporeSigma/EMD Serono

Project: System for RAPID Testing of BIOBURDEN or STERILITY with Automated Imaging Lead: Mango Inc. Participants: Janssen Research & Development, LLC

Project: Developing a Fluorescence-based Continuous (MCSGP) AEX-HPLC Method for Quantification of Full, Partial and Empty Capsid in AAV products Lead: University of Massachusetts Lowell Participants: Artemis Biosystems Inc., Massachusetts Life Sciences Center, MassBiologics of the University of Massachusetts Medical School, Merck

Project: Novel wicking bioreactor for T-cell expansion Lead: Sepragen Corporation Participants: Genentech, Merck, The Research Foundation for the State University of New York, on behalf of State University of New York Polytechnic Institute

Project: Bioprocess Online Training using Digital Twin (BOT-DT) Lead: Keck Graduate Institute Participants: California Polytechnic State University, Catalent Pharma Solutions, LLC., Merck, OUAT!, Santa Clara University, Sartorius Stedim

Project: Modularized PAT Online Training Platform to Accelerate the Workforce Innovation in Biopharmaceuticals Manufacturing Lead: Northeastern University Participants: Genentech, Janssen Research & Development, LLC., Massachusetts Institute of Technology Massachusetts Life Sciences Center, Merck, Sartorius Stedim

Project: Biomanufacturing Consortium for Analytics and Data Engineering (BioCAD) Expansion Lead: Santa Clara University Participants: Genentech, Keck Graduate Institute, Life Science Washington, Oregon Bioscience Association, Pfizer, Inc.

Project: Tunable RF/Microwave Drying of Biologics Lead: Purdue University Participants: IMA Life North America Inc., Merck

Project: Commercial-scale, Aseptic Spray Freeze Dryer Lead: IMA Life North America Inc. Participants: Amgen Inc.

*All funding is subject to project agreement negotiations.

About NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members.


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