The U.S. National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced a $15.8 million funding round earlier this month, explaining the money will be provided to 14 development projects. Institute director Kelvin Lee, PhD, says the idea is to select projects likely to help advance the field of biopharmaceutical production.

“Our industry members work alongside other stakeholders—government, small companies, non-profits, academia and federal stakeholders—to shape and define the priority areas leading to technologies and initiatives that will advance manufacturing innovation and workforce development for the ecosystem,” he tells GEN.

“In addition to our Project Call process, we also have NIIMBL-Led Programs of work that bring the industry together to define a vision for the future state of manufacturing and execute work that demonstrates and realizes that vision.”

Project Call 5.2

Projects selected in the current call (labelled as 5.2) include work on scalable techniques for cell therapy manufacturing, the development of virus and endotoxin clearance strategies for AAV production, and a public-private cell and gene therapy workforce training strategy.

Having a broad range of projects that touch on areas of current biopharmaceutical industry need is important, stresses Lee.

“For this Project Call we did emphasize cell processing; in-line, at-line and online measurements for critical quality attributes (CQAs) and/or process variables; and improving reliability and QA of manufacturing processes on the technology front,” he explains. “On the workforce end we focused on: Industry awareness, pipeline, and talent development; boot camp, capstone, and immersion experiences for students; and technical training in vaccine manufacturing. We rely on the NIIMBL-Led Programs to establish efforts around themes.”

From a manufacturing standpoint, NIIMBL’s aim is to fund the development of practical solutions to industry problems.

“In the technology space, we hope to advance and de-risk the technologies as they progress on a path towards eventual commercial adoption,” Lee says. “For workforce development, we hope to create programs, content, and curricula that will address various aspects of the workforce needs of the industry.

“We also hope to catalyze new ideas, new relationships, and new collaborations across the ecosystem to grow and strengthen the ecosystem for biopharmaceutical manufacturing innovation.”

The majority of the selected projects are led by academic researchers but most also involve scientists from the biopharmaceutical or technology industries.

NIIMBL’s aim by supporting the projects is to facilitate collaboration rather than try and focus industry efforts in any particular area of research.

“It is true that major suppliers can, and do, develop their own technologies. However, we also find that NIIMBL provides a way to get alignment across end user biopharma companies about where they see the industry, and the technology going. Such discussions provide insights that can inform strategies at the suppliers’ level,” Lee explains.

“We also find that the suppliers and biopharma companies alike have a common interest in developing a shared understanding of where the field may progress, where there are opportunities for platform technologies and standards, and where there are spaces for more proprietary innovation.”

Lee wants NIIMBL to be viewed as a broader ecosystem that helps activate organizations to think about the future and provides funding and support to demonstrate and realize those technologies and workforce development opportunities.”

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