FDA and NIIMBL partner to advanced biomanufacturing innovation

The US FDA has expanded its partnership with NIIMBL to strengthen biomanufacturing through innovations such as 3D printing and continuous manufacturing.

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) launched in March 2017 to accelerate innovation in biopharmaceutical manufacturing and support the development of standards to drive more efficient and rapid manufacturing capabilities.

Institute Director, Kelvin Lee told Bioprocess Insider the institute is already working with the US Food and Drug Administration (FDA) in a variety of contexts – from participation in workshops and in technology roadmapping, for example – but a Collaborative Research and Development Agreement (CRADA) between the Agency and the University of Delaware (on behalf of NIIMBL), effective from last month, provides a framework to expand this engagement significantly.

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“These projects could be technology-focused projects or they could be talent development/training projects,” he said. “As an example, currently, NIIMBL posts a project call twice a year to the ecosystem. Project ideas come into NIIMBL from member organizations and Federal agencies. These ideas are vetted and, ultimately, a subset are selected for funding and execution where projects typically have multiple partnering organizations.

“Because of the framework that the CRADA provides, we expect an increase in the number of project ideas that originate from the FDA and also an increase in FDA participation on project teams.”

NIIMBL and the FDA share a vision of fostering advanced manufacturing innovations, he continued. “By supporting technology advancement activities, NIIMBL believes it can de-risk the implementation of new technologies into processes.”

Specific technologies to be advanced will depend on the needs and priorities of the industry, government, and academic stakeholders in NIIMBL, he added.

However, NIIMBL will not likely need to expand to support the CRADA. “NIIMBL already has an infrastructure in place to support and address the needs of the community and has already been interacting with FDA staff in a variety of ways. NIIMBL might expand as the number of projects continues to grow and as our industry membership continues to grow moving forward.”

Training issues

One of the major issues within the biomanufacturing space is the lack of talent. According to some, the lack of trained staff is both driving up manufacturing costs (through salary demands) and leaving some biologics undeveloped. We asked Lee how much this issue is holding industry back.

“We do hear quite a bit that training can be limiting in a variety of contexts. People often talk about biopharma manufacturing as having a negative employment rate – more jobs available than qualified people,” said Lee.

“This need applies to traditional biotechnology products (such as antibodies) which continue to grow in importance; but it is also especially important in the context of some of the new modalities (e.g. cell therapy and gene therapy) where the community’s experience, and available workforce, is limiting.”