NEWARK, Del., April 29, 2025 /PRNewswire/ -- The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce 11 new member-led technology, workforce development, and Global Health Fund projects with a value of ~$11.2 million through the Institute's Project Call 8.1. This new slate of collaborative projects addresses key industry challenges and aims to strengthen domestic biopharmaceutical manufacturing capabilities.

Six projects focus on priority technology areas identified by NIIMBL industry members, including manufacturing platforms for biopharmaceutical products, process analytical technologies, and data science and modeling.

"NIIMBL members are well-positioned to advance current state-of-the-art processes and analytical technologies," said Sandeep Kedia, NIIMBL Senior Technology Fellow. "We are excited about the potential these projects have to advance our ability to manufacture biologic products and push the boundaries of what is possible in biomanufacturing."

The slate of new projects also includes three workforce projects aimed at building awareness and talent pipeline development, ensuring the U.S. has the strongest biopharmaceutical workforce globally.

"To meet the industry's future talent needs, we need to find innovative ways to reach new talent and offer them pathways to begin their careers in the industry," said John Balchunas, NIIMBL Workforce Director. "The new projects will provide new tools to help us do that."

The NIIMBL Global Health Fund (GHF) was established with funding contributed by the Gates Foundation to develop and implement innovative technologies to manufacture preventative medical countermeasures and biologics. Two projects funded as part of Project Call 8.1 focus on reducing the cost of goods to manufacture mRNA-based preventative medical countermeasures.

"With mRNA technologies opening the doors for new therapeutics, we are excited by the opportunities these projects provide to lower costs," said Chris Roberts, NIIMBL Associate Institute Director.

The approximate value of these 11 projects includes NIIMBL funding plus cost share from participating organizations.

Since NIIMBL's launch in 2017, the Institute has awarded 160 projects with a total investment of more than $134 million. NIIMBL is composed of 200+ member organizations from academia, industry, government, and non-profit organizations with a common goal to advance biopharmaceutical manufacturing. Funding for Project Call 8.1 projects is subject to project award negotiations.

For a description of each project and to learn more about NIIMBL, please visit the Project Call 8.1 page.

Project Call 8.1 List

Technology Projects

Project: Automation and Control of a Precipitation-based Continuous Downstream Process for High Titer Products

Lead: Rensselaer Polytechnic Institute

Participants: Astra Zeneca, Boehringer Ingelheim, Bristol Myers Squibb, ChromaTan, Dyadic, Janssen, Merck & Co., Inc., MilliporeSigma, PAK Bio, PendoTECH, Sanofi

Project: Rapid Bioburden and Sterility Testing for Biopharmaceutical Manufacturing

Lead: Mango, Inc.

Participant: Janssen

Project: Single Particle Analyzer for High-throughput and High-content Characterization of Nanoparticle-based RNA Therapy

Lead: Johns Hopkins University

Participants: CICS Analytics, Sartorius Stedim, National Institute of Standards and Technology (NIST)

Project: Integrating High-Throughput Chromatography and Data Science in a Platform for the Rapid and Accurate Quantification of Full, Partial, and Empty AAV Capsids

Lead: North Carolina State University

Participants: Bio Rad Laboratories, Bristol Myers Squibb, Cornell University, LigaTrap Technologies LLC, MilliporeSigma, Refeyn, Rensselaer Polytechnic Institute, Sartorius Stedim, University of Florida

Project: Obtaining Extensive At-line Input and Output Analytics Combined with Machine Learning to Improve Predictive CQA

Lead: Carnegie Mellon University

Participants: Johns Hopkins University, Merck & Co., Inc., Pfizer, Inc., University of Maryland Baltimore

Project: Spectro-acoustic Process Analytical Technology for Real-time Monitoring of Biopharmaceuticals

Lead: Purdue University

Participants: Merck & Co., Inc.

Workforce Projects

Project: Creation of National Standards for a Biomanufacturing Technician Registered Apprenticeship Program

Lead: Apprenti

Participants: InnovATEBIO, LifeScience Workforce Collaborative (LSWC)

Project: Life Sciences Career Hub: Biomanufacturing in Central Massachusetts

Lead: MassBio Education Foundation

Participants: Masschusetts Biomedical Initiative (MBI)

Project: A Day in the Life: Highlighting Careers in Biopharmaceutical Manufacturing

Lead: Bioscience Core Skills Institute (BCSI)

Participants: BioSTL, Merck & Co., Inc., Pfizer, Inc., Texas A&M Engineering Experiment Station (TEES)

Global Health Fund Projects

Project: Lowering the Cost of Goods for Making mRNA Utilizing Continuous Manufacturing

Lead: Sepragen

Participants: University of Massachusetts Lowell, University of Pennsylvania

Project: Lowering mRNA LNP Cost of Goods by Adding a Dose-sparing and Stabilizing Adjuvant

Lead: VaxForm

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 and security. NIIMBL is part of Manufacturing USA®, a 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

Daniel Maiese

Communications Manager

302-831-3824

dmaiese@udel.edu

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SOURCE National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)