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NIIMBL is pleased to announce approximately $10M in planned project activities through the Institute’s Project Call 7.1 for eight new technology and workforce development projects that will help address key opportunities for innovation in biopharmaceutical manufacturing.
Project: Process Intensification for rAAV Manufacturing Using HIP-Vax® and Continuous Countercurrent Tangential Chromatography Technology
Lead: Batavia Biosciences Inc.
Participant(s): ChromaTan Corporation
The goal of this project is to design an upstream and downstream process for production of Recombinant adeno-associated virus (rAAV) vectors, a critical component of gene therapies, using continuous chromatography, alleviating global shortages of the rAAV and reducing costs.
Project: Antibody Mix-and-Read Assays Based on Fluorescence Intensity Probes
Lead: University of Houston
Participant(s): Agilent, Bristol-Myers Squibb, Genentech
This project proposes to improve measurement technologies by developing rapid, simple mix-and-ready assays for antibody and Fc fusion proteins using fluorescence intensity reporters.
Project: Development of Small Molecule Formulations for Enhanced Production of CAR-T Cell Therapies
Lead: Virica Biotech Inc.
Participant(s): AstraZeneca, Sartorius Stedim
This project will explore the use of small molecule Viral Sensitizers (VSE™) to develop more efficient and standardized biomanufacturing processes, bringing life-saving T-cell therapies to market faster and at a reduced cost.
Project: Commercial Deployment of Integrated PAT Technologies to Enable Continuous Upstream Production of Glycosylated Monoclonal Antibodies
Lead: Rutgers, The State University of New Jersey
Participant(s): Agilent, Endress + Hauser Optical Analysis, EnZene Biosciences Ltd, MilliporeSigma/EMD Serono, Pfizer, Inc.
This project will develop integrated process analytical technology (PAT) workflows to rapidly monitor biological drug critical quality attributes (CQAs).
Project: Surrogate ADCs for Process Development and Quality Assessment
Lead: Rensselaer Polytechnic Institute
Participant(s): Carnegie Mellon University, Pfizer, Inc.
The goal of this project is to prepare and characterize a set of non-toxic surrogate ADCs, or “sADCs”, that captures the diversity and processing behaviors of first-generation and second-generation ADCs without the associated toxicity.
Project: Isoelectric Point Purification (IPP) Technology Enables Truly Continuous, End-to-End Chromatography-free Manufacturing to Yield Ultra-high Purity mAbs
Lead: Enquyst Technologies Inc.
Participant(s): Lonza Biologics, Inc., MilliporeSigma/EMD Serono, University of Massachusetts Lowell
This project aims to demonstrate the feasibility of creating a continuous, chromatography-free downstream process for producing ultra-pure mAbs using IPP technology.
Project: Creating a Neurodiverse Talent Pipeline for the Biomanufacturing Industry
Lead: Texas A&M University Engineering Experiment Station
Participant(s): Janssen Research & Development, LLC, Pfizer, Inc., University of California, Los Angeles
This project will create the NeuroPIPES (Neurodiversity Pipelines In biopharmaceutical Employment through Supports) program: a unique program to equip, train, support, and retain neurodivergent talent for the biomanufacturing industry.
Project: BioCAD Data Programming for Biomanufacturing Scale-Up
Lead: Santa Clara University
Participant(s): Biocom California, Genentech, Merck & Co., Inc.
BioCAD Data Programming for Biomanufacturing Scale-up will prepare a biomanufacturing-specific data analytics training program for broad-access and scaled use.
All funding is subject to project agreement negotiations.
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