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NIIMBL Announces 32 Projects Funded Under the American Rescue Plan

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.

 

 

Development of Scalable, Thermostable, Spray Dried Vaccine Formulations Applicable for Coronavirus Vaccines

Lead Organizations: Fraunhofer USA, Merck & Co.

 

 

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: Demonstration & Reference Material

Lead Organization: Massachusetts Institute of Technology

 

Production of NIIMBL’s Antibodies in the Thermothelomyces heterothallica Cl Expression Systems

Lead Organization: Dyadic

 

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.

 

Contact:

News Media

Maria X. Chacon

Director of Marketing and Communications

302-831-2337

mchacon@udel.edu

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