NIIMBL Announces New Projects and Funding for Biopharma 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.

Technology projects

Use of metabolic flux analysis (MFA) to expedite media selection and optimization of Chinese hamster ovary (CHO)

• Lead: MilliporeSigma

• Participant: Metalytics

Mechanistic modeling for enhanced chromatographic productivity

• Lead: Genentech, a member of the Roche Group

• Participants: Merck & Co, ImmunoGen, Rensselaer Polytechnic Institute, Repligen, University of Delaware

Low-cost production and purification of cytokines and growth factors for cell therapy products

• Lead: Potomac Affinity Proteins

• Participant: University of Maryland College Park

Fully automated micro-bioreactor

• Lead: ProMechSys-RLP

• Participants: Genentech, a member of Roche Group, MilliporeSigma, Johns Hopkins University

Blaze microchip system for real-time characterization of intact biopharmaceutical

• Lead: Intabio

• Participants: Genentech, a member of the Roche Group, Celgene, Merck & Co, MilliporeSigma

Improving lyophilization of recombinant proteins with solid-state amide hydrogen/deuterium exchange with mass spectrometric analysis (ssHDX–MS)

• Lead: Purdue University

• Participants: Genentech, a member of the Roche Group, Lindy Biosciences, Aerosol Therapeutics

Continuous cell culture for viral vaccines

• Lead: Massachusetts Institute of Technology (MIT)

• Participants: Massachusetts Life Sciences Center, Merck & Co, Repligen Corporation, University of Massachusetts Medical School

A multiscale metabolic model for fed-batch culture process control

• Lead: University of Minnesota

• Participants: Merck & Co, MilliporeSigma, Metalytics

Small-scale membrane-less perfusion bioreactor system for high-throughput cell-line development and process optimization

• Lead: Massachusetts Institute of Technology (MIT)

• Participants: Massachusetts Life Sciences Center, Genentech, a member of the Roche Group, Merck & Co, MilliporeSigma, Whirlcell

Development of a microchip capillary electrophoresis–high pressure mass spectrometry (CE–HPMS) analyzer for bioreactor monitoring

• Lead: University of North Carolina, Chapel Hill

• Participants: MilliporeSigma, Celgene, 908 Devices, North Carolina State University

Monoclonal antibody (mAb) productivity improvement by metabolic engineering of novel inhibitory biomarker in integrated continuous manufacturing

• Lead: University of Massachusetts Lowell

• Participants: Genentech, a member of the Roche Group, Merck & Co, ImmunoGen, Massachusetts Life Sciences Center, Johns Hopkins University

Nanofluidic analytics platform for multi-modal bioprocess monitoring and real-time product release

• Lead: Massachusetts Institute of Technology (MIT)

• Participants: Genentech, a member of the Roche Group, MilliporeSigma, Massachusetts Life Sciences Center, Redbud Labs

A transcriptome-based model for improved chimeric antigen receptor T-cell (CAR-T) therapy

• Lead: Villanova University

• Participants: Merck & Co, Redbud Labs

In-line self-calibrated pH monitoring system with hyperspectral imaging and deep learning

• Lead: University of Maryland College Park

• Participants: Genentech, a member of the Roche Group, ImmunoGen, Artemis Biosystems

Workforce projects

Online lyophilization short course

• Lead: Purdue University

• Participants: Merck & Co, North Carolina State University

Development of an e-learning library for new biotech employees

• Lead: University of Maryland College Park

• Participant: Merck & Co

Biopharmaceutical manufacturing for FDA

• Lead: University of Maryland College Park

• Participant: North Carolina State University

A microlearning capability for a busy biopharmaceutical workforce

• Lead: Fraunhofer USA

• Participant: University of Maryland College Park

Merck–New Jersey Innovation Institute biopharmaceutical training acceleration proposal (BTAP)

• Lead: New Jersey Innovation Institute

• Participant: Merck & Co

Characterization of cell therapy products by flow and laser force cytometry

• Lead: Rensselaer Polytechnic Institute

• Participants: Celgene, LumaCyte

A continuous improvement, rapid training development, and workforce attraction program for the biomanufacturing industry

• Lead: BioBuzz Workforce Foundation

• Participants: RoosterBio, University of Maryland College Park

Stackable credentials for biotechnology workforce development

• Lead: Shoreline Community College

• Participants: Celgene, Life Science Washington

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.

Source: NIIMB