NEWARK, Del., October 5, 2021 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce approximately $3M in funding for 6 new projects in technology specifically aimed to support the NIIMBL non-profit and academic member community through the Institute’s Project Call 5.1.
The purpose of Project Call 5.1 is to work with relevant partners to perform a small-group study that will help determine the variability associated with key product attributes for therapeutic proteins such as recombinant monoclonal antibodies while investing in state of the art analytical instrumentation infrastructure that will be available across our community to support NIIMBL-related activities in the future in this and related technical areas.
“This project call is a complement to our recent and future project calls, and helps to build infrastructure for NIIMBL efforts in one of the important product characterization technologies for our community. It was implemented in a similar way to recent rapid project calls from NIIMBL that are in parallel with our multi-stage project calls such as PC5.2 that is expected to be announced later this year.” states Chris Roberts, Associate Institute Director.
To date, NIIMBL has now funded over 86 technical, workforce development, and Global Health projects with a total investment of approximately $72M since 2017 when the Institute launched. The NIIMBL community is comprised of more than 180 members from academia, industry, government and non-profit organizations all sharing a common goal to advance biopharmaceutical manufacturing.
For a description of each project and to learn more about NIIMBL, please visit the Project Call 5.1 website.
5.1 Project List
Project: Isomer Level Identification and Quantification of N-Linked Glycans by LC-SLIM-QTOF-MS
Organization: North Carolina State University
North Carolina State University will measure and quantitatively evaluate the glycan profile of a reference monoclonal antibody using an LC-SLIM-QTOF-MS from Agilent Technologies.
Project: Integrated glycan analysis of monoclonal antibodies using UPLC-MS
Organization: University of Massachusetts System
This project will use Waters’ BioAccord LC-MS system to measure glycan variability from a reference monoclonal antibody sample.
Project: Variability in the measured glycan distribution of therapeutic antibodies
Organization: University of Georgia Research Foundation
The University of Georgia will use ion mobility and mass spectrometry to evaluate glycans using Waters’ Synapt system, including an Acquity UPLC I-Class Plus LC and an Acquity UPLC Fluorescence Detector.
Project: Acquisition of a ‘Xevo G2-XS QTof’ Mass Spectrometer and Measurement of Monoclonal Antibody Glycan Heterogeneity by Orthogonal Methodologies
Organization: National Institute for Pharmaceutical Technology and Education, Inc. (NIPTE) (University of Michigan)
Led by NIPTE member, the University of Michigan, this project will use a Xevo G2-XS QTof Mass Spectrometer (Waters) coupled to an Acquity UPLC H-Class PLUS Bio system (Waters) with a fluorescence detector for released glycan analysis. The team will also employ an orthogonal method for glycan release using GlykoPrep N-glycan kits (Agilent).
Project: Measuring glycans from biopharmaceuticals using LC-Q/TOF
Organization: University of Delaware
The University of Delaware will apply an Agilent 1290ii uHPLC, 6545XT Advance Bio Q/TOF to quantitatively measure glycan variability.
Project: Acquisition and Benchmarking of a Perkin Elmer LabChip CXII Touch Protein Characterization System
Organization: Carnegie Mellon University
Using a Perkin Elmer LabChip CXII Touch Protein Characterization System, Carnegie Mellon University will explore glycan distribution from a monoclonal antibody.
*All funding is subject to project agreement negotiations.
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.
Maria X. Chacon
Director of Marketing and Communications