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The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) revealed 22 new projects and funding aimed to advance US biopharmaceutical manufacturing.
On Jan. 9, 2019, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a Manufacturing USA institute, announced 14 technology and eight workforce development projects to advance biopharmaceutical manufacturing in the United States.
The 22 projects have an approximate value of nearly $13 million, including NIIMBL funding and cost share from participating organizations. The NIIMBL portfolio now includes a total investment of more than $45 million across 44 technology and workforce development projects.
The new projects are a result of Project Call 2.1, a solicitation issued by the institute in May 2018 for projects addressing key technology and workforce priority areas defined by industry members. NIIMBL reports that industry partners account for half of the 36 project participants in this round of funding, including technology projects led by Genentech, a member of the Roche Group, and MilliporeSigma. Project teams also consist of leading research institutions, community colleges, and non-profits.
NIIMBL is one of 14 USA Institutes that support US leadership in biopharmaceutical manufacturing through innovative technologies, workforce training, and standards development.
Subject to project award negotiations, NIIMBL intends to fund the following technology and workforce projects.
Use of metabolic flux analysis (MFA) to expedite media selection and optimization of Chinese hamster ovary (CHO)
Mechanistic modeling for enhanced chromatographic productivity
Low-cost production and purification of cytokines and growth factors for cell therapy products
Fully automated micro-bioreactor
Blaze microchip system for real-time characterization of intact biopharmaceutical
Improving lyophilization of recombinant proteins with solid-state amide hydrogen/deuterium exchange with mass spectrometric analysis (ssHDX–MS)
Continuous cell culture for viral vaccines
A multiscale metabolic model for fed-batch culture process control
Small-scale membrane-less perfusion bioreactor system for high-throughput cell-line development and process optimization
Development of a microchip capillary electrophoresis–high pressure mass spectrometry (CE–HPMS) analyzer for bioreactor monitoring
Monoclonal antibody (mAb) productivity improvement by metabolic engineering of novel inhibitory biomarker in integrated continuous manufacturing
Nanofluidic analytics platform for multi-modal bioprocess monitoring and real-time product release
A transcriptome-based model for improved chimeric antigen receptor T-cell (CAR-T) therapy
In-line self-calibrated pH monitoring system with hyperspectral imaging and deep learning
Online lyophilization short course
Development of an e-learning library for new biotech employees
Biopharmaceutical manufacturing for FDA
A microlearning capability for a busy biopharmaceutical workforce
Merck–New Jersey Innovation Institute biopharmaceutical training acceleration proposal (BTAP)
Characterization of cell therapy products by flow and laser force cytometry
A continuous improvement, rapid training development, and workforce attraction program for the biomanufacturing industry
Stackable credentials for biotechnology workforce development
Additionally, on Jan. 10, 2019, the institute announced that it received a grant to help fund the advancement of biopharmaceutical manufacturing technology in the US and globally from the Bill & Melinda Gates Foundation. NIIMBL will receive up to $1.5 million from the foundation to support the development of innovative technologies to reduce the cost of manufacturing biopharmaceuticals. The institute states that the grant provides a valuable resource for leading scientists and subject matter experts from the NIIMBL community to develop manufacturing technology solutions that increase speed to market and lower costs for biopharmaceuticals.
As a result of this grant, the foundation will participate in NIIMBL activities including technology workshops, teaming meetings, technology road mapping, and committees.
As part of the grant, NIIMBL funds will be awarded through a project call process in which teams comprised of NIIMBL members will propose innovation projects that align with the goals and priority topics articulated by NIIMBL and the foundation. Like other NIIMBL project calls, these teams will offer at least a 1:1 matching commitment from project partners. Project teams are limited to NIIMBL members only.