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NIIMBL Project Update


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Recently launched projects drive biopharmaceutical manufacturing innovation.

Newark, DE, August 30, 2018 – The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce a group of projects, designed to advance biopharmaceutical manufacturing and workforce development in the United States.

The projects represent approximately $14 million of activity over 18 months and involve 24 unique organizations.

These collaborative innovation projects were awarded in response to NIIMBL’s Quick Start Project (QSP) call as well as proposals initiated by NIIMBL state partners:

  • Flow Water Proton NMR as Contact Free Real-Time In-Line PAT for Continuous Biomanufacturing (Led by University of Maryland, Baltimore with partner ChromaTan Corporation)
  • Scale-up Studies on Single Use Settlers for Clarifying Cell Culture Broth (Led by Sudhin Biopharma Co. with Genentech, a member of the Roche Group)
  •  At-line Detection of Viral and Bacterial Contaminants in Mammalian Cell Culture Using High Affinity Probes and Label-fee Single-Cell Analysis (Led by Carnegie Mellon University with LumaCyte LLC and Genentech, a member of the Roche Group)
  • Center of Excellence in Host-Cell Protein Analysis (Led by the University of Delaware)


The group also includes projects in automation training, lyophilization, gene therapy vector production, and process control.

“These projects are a significant milestone for the Institute. We appreciate the interest and enthusiasm with which our early members approached the proposal process and look forward to the transformative technologies and critical training solutions these projects promise to bring to the industry,” said Kelvin Lee, NIIMBL Institute Director.

Further details for each of these projects can be found at

In addition, the NIIMBL Governing Committee authorized $18 million of funding for Project Call 1.0 projects. These projects further expand and deepen the work being done in support of biopharmaceutical manufacturing innovation. These projects include:

  • A Lentiviral Vector Production Platform Process
  • A Novel Perfusion-based 3D Bioreactor for Effective Selection, Activation, and Transduction of T-cells for Immuno-Gene Therapy
  • At-Bioreactor Trace Metal Quantification and Statistical Process Control in CHO Cell-Culture Production
  • Blended Learning for Training of Cell Therapy Manufacturing Personnel
  • Development of Course Modules for Certificates and Professional Masters Degree Programs in Manufacturing Leadership for Excellence in Cell Manufacturing
  • Identification, Characterization and Removal of Host-Cell Proteins (HCP) in Chinese Hamster Ovary (CHO) Monoclonal Antibody Biomanufacturing Processes
  •  Label-free Critical Quality Attributes of CAR T-Cell Products
  • Next Generation Sequencing (NGS) Internal Controls for Adventitious Agent Testing to Ensure Sensitivity for All Targets in Every Sample
  • Novel Dehydration Technology to Streamline Drug Substance Processing and Preservation
  • Partnership for Workforce Development in the Biopharmaceutical Industry
  • Quantitative Trilineage Differentiation Assays for cGMP Cell Manufacturing of Human Mesenchymal Stem Cells
  • Rapid Adventitious Agent Testing for Fail-Fast Process Decision-Making
  • Reducing Door‐to‐Floor: Improving Readiness of New Hires through cGMP Hands‐on Biopharmaceutical Training
  • Stackable Credentials to Strengthen the Pipeline to Biopharma
  • The Atmospheric Spray Freeze Drying (ASFD) Project
  • Use of Carbon Thin Films to Reduce Leachable Contamination


All projects are subject to finalized contracts prior to launch.


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.

Media Contact

Dan Maiese

NIIMBL Communications Director



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