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NIIMBL Announces New Projects to Advance Biopharmaceutical Manufacturing

NEWARK, Del., January 9, 2018 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a Manufacturing USA institute designed to advance biopharmaceutical manufacturing in the U.S., is proud to announce the selection of 14 technology and 8 workforce development projects as a result of Project Call 2.1.

The 22 projects have an approximate value of nearly $13M, including NIIMBL funding and cost share from participating organizations. The NIIMBL portfolio now includes a total investment of more than $45M across 44 technology and workforce development projects.

Project teams represent the diversity of expertise and interests found within the NIIMBL community. Industry partners account for half of the 36 project participants in this round of funding, including technology projects led by Genentech, a member of the Roche Group, and MilliporeSigma. Project teams also consist of leading research institutions, community colleges, and non-profits.

“We would like to thank the NIIMBL partners who responded enthusiastically to our latest project call. Through this process, we were able to select a group of projects that we believe will help address common challenges and demonstrate significant value to the industry,” said Kelvin Lee, NIIMBL Institute Director.

The Institute issued project call 2.1 in May. Project Call 2.1 solicited projects addressing key technology and workforce priority areas defined by industry members.

As one of 14 manufacturing USA Institutes, NIIMBL strengthens U.S. leadership in biopharmaceutical manufacturing through innovative technologies, workforce training, and standards development. NIIMBL convenes large biomanufacturers, suppliers, small companies, academic institutions, and government agencies to collaborate on projects that address shared manufacturing challenges and develop the biopharmaceutical workforce.

Subject to project award negotiations, NIIMBL intends to fund the following technology and workforce projects:

Technology Projects

Use of Metabolic Flux Analysis (MFA) to Expedite Media Selection and Optimization of CHO

Lead: MilliporeSigma

Participant: Metalytics

Mechanistic Modeling for Enhanced Chromatographic Productivity

Lead: Genentech, a member of the Roche Group

Participants: Merck & Co., Inc., ImmunoGen, Inc., Rensselaer Polytechnic Institute, Repligen Corporation, University of Delaware

Low-cost Production and Purification of Cytokines and Growth Factors for Cell Therapy Products

Lead: Potomac Affinity Proteins

Participant: University of Maryland College Park

Fully Automated Micro-Bioreactor

Lead: ProMechSys-RLP, LLC

Participants: Genentech, a member of Roche Group, MilliporeSigma, Johns Hopkins University

Blaze™ Microchip System for Real-Time Characterization of Intact Biopharmaceutical

Lead: Intabio

Participants: Genentech, a member of the Roche Group, Celgene, Merck & Co., Inc., MilliporeSigma

Improving Lyophilization of Recombinant Proteins with ssHDX-MS

Lead: Purdue University

Participants: Genentech, a member of the Roche Group, Lindy Biosciences, Inc., Aerosol Therapeutics

Continuous Cell Culture for Viral Vaccines

Lead: Massachusetts Institute of Technology (MIT)

Participants: Massachusetts Life Sciences Center, Merck & Co., Inc., Repligen Corporation, University of Massachusetts Medical School

A Multiscale Metabolic Model for Fed Batch Culture Process Control

Lead: University of Minnesota

Participants: Merck & Co., Inc., MilliporeSigma, Metalytics

Small-scale Membrane-less Perfusion Bioreactor System for High-throughput Cell Line Development and Process Optimization

Lead: Massachusetts Institute of Technology (MIT)

Participants: Massachusetts Life Sciences Center, Genentech, a member of the Roche Group, Merck & Co., Inc., MilliporeSigma, Whirlcell Pte. Ltd.

Development of a Microchip CE-HPMS Analyzer for Bioreactor Monitoring

Lead: University of North Carolina, Chapel Hill

Participants: MilliporeSigma, Celgene, 908 Devices, Inc., North Carolina State University

mAb Productivity Improvement by Metabolic Engineering of Novel Inhibitory Biomarker in Integrated Continuous Manufacturing

Lead: University of Massachusetts Lowell

Participants: Genentech, a member of the Roche Group, Merck & Co., Inc., ImmunoGen, Inc., Massachusetts Life Sciences Center, Johns Hopkins University

Nanofluidic Analytics Platform for Multi-Modal Bioprocess Monitoring and Real-Time Product Release

Lead: Massachusetts Institute of Technology (MIT)

Participants: Genentech, a member of the Roche Group, MilliporeSigma, Massachusetts Life Sciences Center, Redbud Labs, Inc.

A Transcriptome-based model for improved CAR-T Therapy

Lead: Villanova University

Participants: Merck & Co., Inc., Redbud Labs, Inc.

In-line Self-calibrated pH Monitoring System with Hyperspectral Imaging and Deep Learning

Lead: University of Maryland College Park

Participants: Genentech, a member of the Roche Group, ImmunoGen, Inc., Artemis Biosystems Inc.

Workforce Projects

Online Lyophilization Short Course

Lead: Purdue University

Participants: Merck & Co., Inc., North Carolina State University

Development of an e-Learning Library for New Biotech Employees

Lead: University of Maryland College Park

Participant: Merck & Co., Inc.

Biopharmaceutical Manufacturing for the FDA

Lead: University of Maryland College Park

Participant: North Carolina State University

A Microlearning Capability for a Busy Biopharmaceutical Workforce

Lead: Fraunhofer USA

Participant: University of Maryland College Park

Merck-NJII Biopharmaceutical Training Acceleration Proposal (BTAP)

Lead: New Jersey Innovation Institute

Participant: Merck & Co., Inc.

Characterization of Cell Therapy Products by Flow and Laser Force Cytometry

Lead: Rensselaer Polytechnic Institute

Participants: Celgene, LumaCyte, LLC

A Continuous Improvement, Rapid Training Development, and Workforce Attraction Program for the Biomanufacturing Industry

Lead: BioBuzz Workforce Foundation, Inc.

Participants: RoosterBio, Inc., University of Maryland College Park

Stackable Credentials for Biotechnology Workforce Development

Lead: Shoreline Community College

Participants: Celgene, Life Science Washington

About NIIMBL

NIIMBL is a public-private partnership with the goal of advancing innovation in biopharmaceutical manufacturing. NIIMBL is part of Manufacturing USA®, a network of 14 manufacturing institutes across the country that brings together industry, academia, and the public sector to propel promising research developments, accelerate new products to market, and train tomorrow’s workforce in order to secure America’s future. NIIMBL is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce, and leverages additional support from industry, academic institutions, non-profit organizations, and the states of Delaware, Maryland, North Carolina, and the Commonwealth of Massachusetts. The NIIMBL 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.

Contact: Daniel Maiese, Communications Manager

dmaiese@udel.edu 302-831-3824

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