NEWARK, Del., August 27, 2019 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is proud to announce the selection of 15 new technology and talent development projects designed to advance biopharmaceutical manufacturing in the U.S.
Subject to project award agreement negotiations, the selected projects have a total value of approximately $9M with $4.3M in funding from NIIMBL and the remaining funds contributed by participating organizations. With the addition of these nine technology and six talent development projects, NIIMBL’s portfolio grows to 58 projects with a total investment reaching nearly $58M since 2017. These projects include analytical assays, upstream and downstream processes and approaches used for both existing and emerging products, and new biopharmaceutical curricula at colleges and universities.
This latest round of projects includes collaboration between 35 NIIMBL members and the National Institute of Standards and Technology (NIST). Across the portfolio, there are a total of 77 organizations actively participating on NIIMBL-funded technology and talent development projects including federal agencies NIST and the FDA.
“These new projects further strengthen NIIMBL’s commitment to addressing common challenges and advancing manufacturing technologies and talent development programs for the U.S. biopharmaceutical industry,” said Kelvin Lee, NIIMBL Institute Director. “We look forward to working closely with these teams as these projects develop.”
These projects were selected from the pool of proposals submitted in response to NIIMBL’s Project Call 2.2 announced on November 30, 2018. The call for proposals solicited innovative concepts addressing shared technology challenges and workforce gaps in the biopharmaceutical industry.
Below is a summary of the latest NIIMBL projects. To learn more about NIIMBL and how to learn how to submit your project for consideration in the next Project Calls- 3.1, including the Global Health Fund, visit NIIMBL.org.
Project Call 2.2 NIIMBL Selections:
A Multivariate In-Line Optochemical Sensor Platform for Continuous Monitoring of Cross-Category Process Parameters and Product Attributes in Bioreactors
Lead: North Carolina State University
Participant: MilliporeSigma, Pfizer Inc.
This project develops a multi-attribute inline optochemical sensor platform for continuous monitoring of bioreactors at all scales. This multiplexed fiber-optic sensor platform will monitor, for the first time, cross-category variables, such as metabolites (e.g., glucose), dissolved O2 (DO), and dissolved CO2 (DCO). This technology will shorten conventional analytical tests for bioreactors from multiple days to real-time, which is a critical step toward closed feedback control loops that enable continuous and adaptable manufacturing.
ADC Surrogates for Process Development
Lead: Rensselaer Polytechnic Institute
Participants: 908 Devices, Inc., AstraZeneca, Carnegie Mellon University, MilliporeSigma, National Institute of Standards and Technology
While Antibody-Drug Conjugates (ADCs) are an important, growing class of anti-cancer drugs, they are dangerous to handle and require elaborate containment facilities, personnel protection devices, and cleaning protocols. This makes process development efforts expensive and limited in scope and restricts the ability for industry to train new professionals on proper handling of ADCs. This project will improve ADC process development efforts by identifying non-toxic molecules that mimic the chemical properties and processing behaviors of ADCs.
Expanding AAV Process and Characterization Analytical Technologies
Lead: North Carolina State University
Participants: AstraZeneca, NIST, Pfizer, Inc.
This project seeks to pioneer the application of multi-attribute method (MAM) mass spectrometry and ion mobility spectrometry (IMS) to the gene therapy space. Modality-targeted development will provide the specificity and speed necessary to meet the emerging demands of process development and set improved industry standards for key product attributes.
Continuous Countercurrent Spiral Chromatography (CCSC) – Feasibility, Demonstration and Commercialization
Lead: ChromaTan Corporation
Participants: Genentech, Merck & Co. Inc., Pennsylvania State University
The objective of this project is to commercialize a new device format called the spiral sorter into process development within the Continuous Countercurrent Tangential Chromatography (CCTC) framework by utilizing additive manufacturing tools, hydrodynamic modeling, scale-up, pilot-scale Protein A antibody capture campaigns and economic analysis. It is projected that this new approach Continuous Countercurrent Spiral Chromatography (CCSC) will provide significant savings for clinical purification and enable robust and steady-state continuous purification for long-term operations.
Highly Multiplexed, PCR-less AA Detection for Biomanufacturing Processes and Product Release
Lead: Carnegie Mellon University
Participants: MilliporeSigma, Rensselaer Polytechnic Institute
The purpose of this project is to identify changes in miRNA and/or mRNA expression to more rapidly detect infection by adventitious agents. This method could save potential lost production time for manufacturers of biological therapeutics when a positive result is detected. The sooner adventitious agents are detected immediate corrective action can be taken to ensures product quality is not compromised and minimize or reduce further delays to final product release for more efficient accessibility to patients.
Inline Spiking Method for Validation of Virus Clearance in Continuous Bioprocessing
Lead: Pennsylvania State University
Participants: Genentech, Merck & Co., Inc., MilliporeSigma, MockV Solutions, Inc.
The overall objective of this project is to develop an inline spiking protocol suitable for use in the evaluation and validation of virus clearance in connected / continuous bioprocessing. The protocol will address the challenge in connected / continuous processing by developing a reliable small-scale system capable of accurately evaluating virus clearance. Potential savings will be realized in reduced production time and risk within the overall process. The project will also assess costs, materials and assay requirements, and personnel needs for implementation of inline spiking for virus validation of continuous processing, providing a framework for implementation of this technology as part of the virus validation package for approval of biopharmaceutical products.
Non-invasive PAT for Aluminum-adjuvanted Vaccines
Lead: University of Maryland Baltimore
Participants: Merck & Co., Inc., Pfizer Inc.
This project will develop a real-time, non-invasive process analytical technology for biopharmaceutical products using nuclear magnetic relaxation of water. Because water is the solvent for all bioprocessing operations and all biologic products, water Nuclear Magnetic Resonance (wNMR) is a true platform technology for biomanufacturing, both for process monitoring and product inspection. This technology will be used to characterize the aluminum-antigen adsorption process and evaluate the stability of antigen-aluminum complex under stress. This non-invasive, real-time approach limits contamination and enables uninterrupted manufacturing operation reducing time and cost.
Real-time Analysis of Functional Health of Cells Through Cell Mechanics Monitoring and Sorting
Lead: Georgia Tech Research Corporation
Participants: Celgene Corporation
This project designs a microfluidic viability sensor integrating electronic Coulter-like cell counters into the microchannel to yield a microfluidic device for real-time counting of viable and nonviable cells. In a second segment, viable cells will be purified after culture for primary T-cells. The insight pursued in this proposal is that cell biophysical properties can be used as a surrogate to identify desired functional phenotypes of cells. If this is accomplished, the project will allow for continuous measurement of the culture health with minimal cell loss, and the net yield and resource efficiency of the batch culture will increase.
Scalable Microfluidics that Can Address the Challenge of Delivery of Large Transgenes to Therapeutic Cells
Lead: Georgia Tech Research Corporation
Participants: CellFE, Inc., Celgene Corporation, Merck & Co., Inc., University of Iowa
The goal of this project is to provide a practical microfluidic method for transfection of therapeutic transgenes that are virus-free, GMP-compliant, scalable across a large range of cell counts, and capable of transgene delivery to different cell types. It will focus on T-cells and iPSCs due to their importance for cell therapy manufacturing, and will potentially provide the first non-viral platform for transgene transfection in cell product manufacturing from bench to final product using a single protocol.
Talent and Workforce Development Projects
Bridging the Gap: A Biopharmaceutical Processing Workforce Development Continuum
Lead: Thomas Jefferson University
Participant: Merck & Co., Inc., Bucks County Community College, Montgomery County Community College
This workforce project establishes a partnership between two community colleges, one university, a bioprocessing center, and a biomanufacturer for the purpose of identifying and closing gaps in existing community college biomanufacturing curriculum. Through engagement with industry, the team will identify training gaps and the skills and competencies to meet industry needs. Academic partners will then develop and pilot the delivery of curriculum modules to a cohort of community college students. The cross-institutional partnership will also pilot the development of transcriptable and transportable course credits – allowing students to move seamlessly between participating organizations as they complete their training and transition to industry.
Building Cooperative Biomanufacturing Workforce Training Network
Lead: University of Massachusetts System
Participant: Massachusetts Institute of Technology, Merck
This project is focused on establishing a biomanufacturing training network in Massachusetts that will serve as the state-wide consortium for guiding the development of industry training courses. The project will focus on the development of 3-4 short courses for industry professionals based on advisory-committee driven standards. Course topics will include (1) lyophilization, (2) continuous manufacturing, (3) data analytics and model applications, and (4) gene therapy. Curriculum standards and course materials will be shared freely among the members of this state-wide consortium, enabling courses to be taught at multiple locations and paving the way for potential future expansion beyond Massachusetts. Courses will be available to the public and offered to NIIMBL members at a discounted rate.
Gene Therapy Training Network (GTTN) and Instructional Transfer Platform (ITP)
Lead: North Carolina State University
Participants: Texas A&M University
This workforce development project aims to create a training and education network for the emerging field of gene therapy vector manufacturing. The network will leverage and improve upon a gene therapy short course developed in a previous NIIMBL project, transfer courses to other institutions within NIIMBL, and standardize course content and curriculum.
SPIDER Project 2.0
Lead: University of Maryland College Park
Participant: Frederick Community College, Fraunhofer USA, Genentech, International Academy of Automation Engineering, Merck & Co., Inc., North Carolina State University, Solano College, Worcester Polytechnic Institute
SPIDER 2.0 (Sensors and software for Process control, Integration, Data analysis, process Evolution, and Reporting) builds on the previously NIIMBL-funded project, SPIDER 1.0, which established testbeds and blended training solutions for automation in biomanufacturing. The project intends to improve upon and expand the SPIDER network at the three original sites plus one additional training center on the west coast. Additional courses will also be developed in data acquisition, data visualization, data analytics, data modeling, as well as the skills of communicating the value of digital technologies for biomanufacturing.
WORDE: A Biopharmaceutical Training Center to Promote Development of the Workforce, Outreach, Research, Diversity, and Education
Lead: Delaware State University
Participants: Merck, Solano College
This workforce project seeks to establish the WORDE Institute at Delaware State University that will support the on-site development of the Biopharmaceutical Workforce, Outreach, Research, Diversity, & Education at its Wilmington campus. Through the purchasing of key equipment, professional development via train-the-trainer, and the creation of curriculum, Delaware State will be positioned to offer biopharmaceutical curriculum to its student population.
Workforce Expansion in Biomanufacturing Emerging Technologies
Lead: Solano College
Participant: Forsyth Technical Community College, Montgomery County Community College, Quincy College, Shoreline Community College
This workforce project seeks to help prepare community college graduates for careers in gene and cell-based therapies. The project team will gather pertinent information about curriculum, equipment, and training needs through labor market research and regional meetings with industry leaders. After developing a curriculum, the team will conduct train-the-trainer sessions to prepare faculty from U.S.-based community colleges to provide instruction in cell and gene-based therapies.
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 advance innovation 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, 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.
Maria X. Chacon
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