NEWARK, Del., May 19, 2020 /PRNewswire/ — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announced funding for 14 new projects in technology, workforce development, and in their Global Health Fund initiative, resulting from the Institute’s Project Call 3.1, and with a total value of approximately $10M.

«New manufacturing technologies are crucial to bringing safe, life-saving treatments to patients faster and, now more than ever, the biopharma industry, is seeing an increased demand for skilled talent,» states Kelvin H. Lee, Institute Director, adding, «NIMBL is strategically positioned to bring forth collaborative innovation to meet the growing needs of the industry through our industry, academic and government stakeholders.»

As a result of these new Project Call 3.1 projects, NIIMBL is bolstering their technology portfolio to include critical areas such as process analytical technologies for contaminant detection, cell therapy manufacturing processes, single-use components for continuous manufacturing, and data analytics applications in biomanufacturing. The workforce projects selected offer a range of new skills for incumbent workers in the field of cell therapy, tap into the skills and dedication of military members to provide new career avenues, and pilot industry-academia hybrid training to provide relevant and valued skills especially with today’s virtual needs.

For the first time, two of these new projects are part of the Global Health Fund in partnership with The Bill & Melinda Gates Foundation. These projects explore cutting-edge technologies that will reduce animal-based testing and improve vaccine manufacturing processes.

«The demands on the biopharmaceutical industry have grown exponentially over the last few months as our world is facing unprecedented times. The projects we have selected will address various key areas, ultimately adding speed, efficiency, and potential savings to an industry that must always be prepared to move quickly,» shares Lee.

To date, NIIMBL and its members have invested $63M in 71 technology and workforce development projects since the Institute’s launch in 2017. Currently, NIIMBL has more than 150 member organizations throughout academia, industry and government.

For a description of each project and to learn more about NIIMBL, please visit NIIMBL.org.

3.1 Project List

Technology Projects

Rapid Endotoxin Detection and Removal Technologies to Overcome Low Endotoxin Recovery
Lead: Missouri University of Science and Technology
Participants: Sartorius, Merck & Co., Inc.

Automated Process Control of Pharmaceutical Lyophilization: PAT Enabled Freeze-Dryer
Lead: Physical Sciences, Inc.
Participants: Merck & Co., Inc., Pfizer, Genentech, University of Massachusetts Lowell, NIPTE, SP Scientific

Single-use modules for continuous removal of antibody fragments
Lead: North Carolina State University
Participants: Rensselaer Polytechnic Institute, LigaTrap Technologies, LLC., Merck & Co., Inc., MilliporeSigma/EMD Serono

A Novel Beads-free CAR T-Cell Manufacturing Platform
Lead: Southwest Research Institute
Participants: Genentech, Merck & Co., Inc., University of Pennsylvania, Xcellerate Biotech Inc.

Specific Detection of Infected Cells using Optical Drag-Tags in Laser Force Cytology
Lead: Carnegie Mellon University
Participants: Merck & Co., Inc., LumaCyte, LLC, Rensselaer Polytechnic Institute

Cell separation, processing, and expansion for cell therapy applications
Lead: University of Delaware
Participants: Merck & Co., Inc., MilliporeSigma/EMD Serono

Multi-Analyte In-line Sensor for Biomanufacturing Applications Based on Analyte-Responsive Smart Hydrogels
Lead: Applied Biosensors
Participants: Merck & Co., Inc., MilliporeSigma/EMD Serono

Machine Learning Approaches to Characterization and Root-Cause Analysis of Particulates Formed During Protein Formulation Fill-Finish Operations
Lead: Regents of the University of Colorado (Boulder)
Participants: Merck & Co., Inc., PMT

Talent and Workforce Development Projects

Cell-Based Therapy Training Program for Incumbent Workers
Lead: Shoreline Community College
Participants: Bristol-Myers Squibb

Military Service Members in Biopharma Manufacturing (MSMBM)
Lead: Texas A&M University System
Participant: North Carolina Biotechnology Center, Central Carolina Community College, Pfizer, Inc., Wake Technical Community College, Gaston College, Durham Technical Community College, Merck & Co., Inc.

West Coast Biomanufacturing Consortium for Automation and Data analytics (BioCAD)
Lead: Santa Clara University
Participant: Genentech

New Model for Developing Early System Level Thinkers Using Hybrid Industry-Academia Training
Lead: Rensselaer Polytechnic Institute
Participants: MilliporeSigma/EMD Serono

Global Health Fund Projects

International in-house validation of the Pertussis Serological Potency Test (PSPT) in mice to replace the in vivo challenge Mouse Protection Test in whole-cell Pertussis (wP) vaccine batch testing
Lead: Developing Countries Vaccine Manufacturers Network

Evaluation of next generation sequencing (NGS) as a rapid, alternative assay for in vivo and in vitro adventitious virus testing for vaccine safety
Lead: FDA
Participants: MilliporeSigma/EMD Serono, GlaxoSmithKline, LLC, University of Delaware

*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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SOURCE National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)