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.
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
This project advances a fully continuous downstream process for monoclonal antibody production by replacing Protein A chromatography with precipitation-based capture and flowthrough polishing, addressing critical steps toward commercialization while enhancing cost-efficiency, throughput, and sustainability.
Project: Rapid Bioburden and Sterility Testing for Biopharmaceutical Manufacturing
Lead: Mango, Inc.
Participant: Janssen
This project introduces a rapid bioburden monitoring solution using advanced imaging and machine learning to reduce detection time to under 24 hours, enhancing contamination control and supporting regulatory-compliant biomanufacturing.
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)
This project will advance single-particle analytical capabilities for RNA LNPs by developing a compact, user-friendly CICS system to enable high-resolution, quantitative analysis of RNA payload distribution and empty particle content for improved product quality control.
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
This project seeks to standardize Adeno-Associated Virus (AAV) capsid isolation and create a shared knowledge platform to streamline process development, de-risk workflows, and enhance efficiency across multiple serotypes.
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
This project aims to enable real-time prediction and control of glycosylation in mAb production, reducing experimentation time and enhancing process efficiency through hybrid modeling and machine learning.
Project: Spectro-acoustic Process Analytical Technology for Real-time Monitoring of Biopharmaceuticals
Lead: Purdue University
Participants: Merck & Co., Inc.
This project will advance the use of Raman and FTIR spectroscopy, combined with machine learning (ML), to improve particle characterization and in-process monitoring in biopharmaceutical manufacturing.
Project: Creation of National Standards for a Biomanufacturing Technician Registered Apprenticeship Program
Lead: Apprenti
Participants: InnovATEBIO, LifeScience Workforce Collaborative (LSWC)
This project aims to develop National Apprenticeship Standards, which can be shared freely across the country to streamline development of regional programs.
Project: Life Sciences Career Hub: Biomanufacturing in Central Massachusetts
Lead: MassBio Education Foundation
Participants: Massachusetts Biomedical Initiative (MBI)
MBI and MassBioEd seek to create a comprehensive Life Sciences Career Hub, which will introduce students and adults to the industry and pathways into careers.
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)
This project aims to create an engaging “A Day in the Life” video series that provides an immersive look into biomanufacturing careers. These videos will highlight professionals across various roles, detailing career pathways, job responsibilities, and industry contributions.
Project: Lowering the Cost of Goods for Making mRNA Utilizing Continuous Manufacturing
Lead: Sepragen
Participants: University of Massachusetts Lowell, University of Pennsylvania
This project will focus on lowering the cost-of-goods of mRNA Drug Substance (DS) with our innovative CAMERNA (Continuous Automated Manufacturing Equipment for mRNA) system.
Project: Lowering mRNA LNP Cost of Goods by Adding a Dose-sparing and Stabilizing Adjuvant
Lead: VaxForm
VaxForm proposes to incorporate its formulation platform utilizing aluminum adjuvant particles to improve efficacy and stability. The improved efficacy allows for a reduction of the dose needed to be administered (dose-sparing) and therefore reduces manufacturing costs as fewer raw materials are necessary to produce lower doses.
All funding is subject to project agreement negotiations.
If you have questions, contact [email protected].
We offer a variety of membership options that give you the flexibility to choose your organization’s level of engagement based on technology interests and priorities.
