Newark, Del., December 20, 2021— Today, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced 32 coronavirus response projects to multiple organizations across the United States funded through the American Rescue Plan (ARP).
NIIMBL identified projects that will help the nation prevent, prepare for, and respond to coronavirus public health threats. Additionally, six of the projects establish research and development testbeds that will support collaborative research and innovation by the NIIMBL community at the NIIMBL headquarters in Newark, DE.
“To move past the current pandemic and prevent and prepare for future public health threats, we must continue to create the technology, infrastructure, and skills that are needed,” shared Kelvin Lee, Institute Director. Lee adds, “This diverse group of technology and workforce development projects addresses multiple public health response capabilities and strengthens the United States’ role as a global leader in biopharmaceutical manufacturing.”
Specifically, through the ARP funding, NIIMBL selected projects that will:
- Provide testbeds for process development, for next generation manufacturing approaches, and for drug product manufacturing approaches that provide access to industrially relevant equipment and facilities for pre-competitive manufacturing innovation
- Support the development of significantly improved methods for vaccine production, quality, and distribution, including mRNA and other vaccine platforms
- Demonstrate rapid scaling for production of coronavirus antigens and medical countermeasures for variants of concern
- Train a diverse biopharmaceutical manufacturing workforce
- Demonstrate the concept of mobile Good Manufacturing Practices capabilities to support mRNA vaccine and gene therapy production
NIIMBL members include large and small companies, academic institutions, non-profits, and federal agency partners who are well-equipped to significantly strengthen the nation’s preparedness and response to public health crises.
The list of funded projects and lead organizations includes:
Supporting Pharmaceutical and Bioproduction Manufacturing with a Certificate in Laboratory Techniques to Provide an Entry-Level Workforce
Lead Organization: Cecil College
Pandemic Preparedness and Response
Lead Organization: Missouri University of Science & Technology
Establishing Testbeds for Biopharmaceutical Manufacturing Workforce Development
Lead Organizations: Texas A&M University, University of Delaware, North Carolina Central University, Xavier University of Louisiana, University of Maryland Baltimore County
Evaluation of an Automated Vapor Phase Hydrogen Peroxide Decontamination System for Rapid, Non-Residual Decontamination of Clinical Spaces
Lead Organization: Sentry Sciences LLC dba PMT (USA)
A New Generation of High-efficiency HVAC Filters to Stop the Spread of Coronavirus
Lead Organization: North Carolina State University – The Nonwovens Institute (NWI)
Rapid Electrophoretic Assay of mRNA Vaccine Quality Attributes
Lead Organization: Carnegie Mellon University
Continuous Purification for mRNA Vaccine Production: Replacing Chromatography with Adsorptive Membranes
Lead Organization: Rensselaer Polytechnic Institute (RPI)
Rapid Continuous Production of Room Temperature Stable mRNA Vaccines
Lead Organizations: University of Massachusetts Lowell, Sepragen Corporation, University of Pennsylvania
LNP-mRNA Vaccine Stability: Reference Materials, Rapid Stability Assessment and Lyophilized Formulation Development
Lead Organizations: Rensselaer Polytechnic Institute (RPI), Carnegie Mellon University
Advanced Characterization and Manufacturing for mRNA Vaccines
Lead Organization: Purdue University
Productivity and Quality of mRNA Vaccines
Lead Organization: North Carolina State University
Development of a Thermo-tolerant, Multidose, Egg-produced, Vector-based Coronavirus Vaccine
Lead Organization: PATH
Accelerating the Manufacture and Scale Up of Virus-like Particle Vaccines
Lead Organization: Massachusetts Institute of Technology
Development of a CHO-based Upstream Process for Rapid Production of Coronavirus Antigen Variants
Lead Organization: MilliporeSigma
Affinity Precipitation Purification of Virus-Like Particles
Lead Organization: University of Delaware
Spectro-acoustic Process Analytical Technology for Continuous Manufacturing of Coronavirus Vaccine
Lead Organizations: Purdue University, Merck & Co.
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Development of Scalable, Thermostable, Spray Dried Vaccine Formulations Applicable for Coronavirus Vaccines
Lead Organizations: Fraunhofer USA, Merck & Co.
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Thermostabilize Coronavirus Vaccines: Formulation and Process Development and Rapid Scale-up Through Modeling and QbD Experimentation
Lead Organizations: Physical Sciences Inc., University of Connecticut, University of Massachusetts Lowell, Merck & Co.
Development of SARS-CoV-2 NGS Internal Standards to Ensure Sufficient Complexity Capture for Variant Detection and Diagnosis
Lead Organization: Accugenomics Inc.
Rapid Single-use PCR-based Nucleic Acid Testing
Lead Organization: Texas A&M University
A Bioelectronic Sensor for Rapid Assessment of Antibody Titer and Glycan Structure
Lead Organization: University of Maryland, College Park
Noninvasive Detection of Counterfeit and Substandard Vaccines and Biotherapeutics
Lead Organization: University of Maryland, Baltimore
Spike Identification Nanobody Panel for SARS-CoV-2 Vaccine Manufacturing
Lead Organizations: Wadsworth Center, New York State Department of Health, University of Massachusetts Medical School
Open-Source Lentiviral Vector and Adenoviral-Associated Viral Vector Manufacturing
Lead Organization: Caring Cross
Monoclonal Antibody Expression in Fast Alternative Hosts:Â Demonstration & Reference Material
Lead Organization: Massachusetts Institute of Technology
Production of NIIMBL’s Antibodies in the Thermothelomyces heterothallica Cl Expression Systems
Lead Organization: Dyadic
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Enhancement of the End-to-End Manufacturing Testbed for Fast, Flexible Drug Substance Manufacturing
Lead Organization: NIIMBL
Next Generation Sequencing Testbed
Lead Organization: NIIMBL
Portable GMP Plasmid Production Testbed
Lead Organization: NIIMBL
NIIMBL Vaccine Analytics and Assays Center of Excellence
Lead Organization: NIIMBL
Process Development Testbed
Lead Organization: NIIMBL
GMP-like Drug Product Testbed Laboratory
Lead Organization: NIIMBL
Visit NIIMBL.org to view a summary of these project and to learn more about NIIMBL.
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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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