NEWARK, Del., August 9, 2022 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce approximately $15.8M in planned project activities through the Institute’s Project Call 5.2 for 14 new projects in technology and workforce development that will help to address key opportunities for innovation in the biopharmaceutical industry.
These projects were selected to best align with key areas of focus identified by NIIMBL and which best align to address industry needs.
“NIIMBL is looking forward to adding these projects to our technology portfolio, advancing our community’s efforts in key areas of cell processing, measurement of critical quality attributes and process variables during biopharmaceutical manufacturing, as well as improving reliability and assuring quality during those manufacturing processes,” states Chris Roberts, Associate Institute Director.
Project Call 5.2 also included several workforce development projects that provide a variety of opportunities to those interested in entering or developing skills within the biopharmaceutical manufacturing industry.
“The newest slate of workforce projects will advance NIIMBL’s workforce and talent development mission by driving industry adoption of alternative pathways into the industry, increasing awareness about biopharmaceutical manufacturing careers in diverse populations, as well as catalyzing new education and professional development in cell therapy, gene therapy, and mRNA vaccine manufacturing,” adds John Balchunas, Director of Workforce Development.
To date, NIIMBL has awarded approximately 100 technical, workforce development, and Global Health Fund projects through the Project Call process with a total project investment of over $95M since 2017 when the Institute launched. The NIIMBL community is comprised of more than 200 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 5.2 website.
5.2 Project List
Project: Integrated Continuous USP Platform for Maximum Productivity and Closed-loop controlled CQA
Lead: University of Massachusetts System
Participant(s): Massachusetts Institute of Technology, Whirlcell LLC., Yokogawa Corporation of America, Pfizer, Inc.
Project: Real-Time, Absolute Quantitation of Critical Bioprocessing Metabolites with the AI-powered Pyxis™ Metabolomics Platform
Lead: Matterworks, Inc.
Participant(s): Sartorius Stedim, Eli Lilly and Company
Project: Innovative Scalable Technologies for Production of Cell Therapies
Lead: University of Delaware
Participant(s): MilliporeSigma/EMD Serono, Agilent
Project: An Integrated Platform for Fully Automated, Continuous, & Real-Time Multi-Attributes Monitoring of Upstream Processes for Glycosylated Monoclonal Antibodies Production
Lead: Rutgers, The State University of New Jersey
Participant(s): University of Delaware, Agilent, Endress + Hauser Optical Analysis,
Project: Virus and Endotoxin Clearance Strategies for Safe and Reliable Production of AAV
Lead: BioCentriq
Participant(s): Pall Corporation/Cytiva
Project: Advanced Bioprocessing Sensor and Analytical Technologies for Induced Pluripotent Stem Cell Culture Online Monitoring and Automation
Lead: Northeastern University
Participant(s): Agilent, Clemson University, MilliporeSigma/EMD Serono, Physical Sciences Inc., University of Massachusetts System
Project: Machine-guided Rapid Decision-making on Quality of Viruses as Products and for Viral Clearance Determination
Lead: Carnegie Mellon University
Participant(s): Sartorius Stedim
Project: Modernizing Clearance and Quantification of Host-cell proteins in mAb Manufacture
Lead: University of Delaware
Participant(s): Bristol-Myers Squibb, National Institute of Standards and Technology, Genentech, LigaTrap Technologies, LLC, Merck & Co., Inc., North Carolina State University, Pfizer, Inc., Rensselaer Polytechnic Institute
Project: Time-gated Raman Spectroscopy to Improve Chemical Sensitivity for In-situ Bioreactor Monitoring
Lead: National Institute for Pharmaceutical Technology and Education, Inc. (NIPTE) (Duquesne University)
Participant(s): Pfizer, Inc.
Project: Biomanufacturing Technician Apprenticeship Program
Lead: MassBio Education Foundation
Participant(s): Northeastern University
Project: Promoting Careers in Biopharmaceutical Manufacturing Operations to High School Students
Lead: North Carolina Biotechnology Center
Participant(s): Merck & Co., Inc., Pfizer, Inc., Pitt Community College
Project: A Public-Private Partnership Strategy for Workforce Training in Cell and Gene Therapy Manufacturing
Lead: University of California, Davis
Participant(s): Eli Lilly and Company, Pall Corporation/Cytiva, Solano College
Project: Bridge to Bio
Lead: University of Virginia
Participant(s): Merck & Co., Inc., Pfizer, Inc.
Project: Modular Training for the Vaccine Development & Manufacturing Workforce
Lead: Massachusetts Institute of Technology
Participant(s): Merck & Co., Inc., Quincy College, Sanofi
*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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