KIETS Director Ruben G. Carbonell is a Senior Technology Strategist for NIIMBL, an institute that is part of the Manufacturing USA Network to enhance the nation’s manufacturing-based economy. NIIMBL’s mission is to advance the economic competitiveness of the US biopharmaceutical industry, to create jobs and improve the economy by accelerating the development and implementation of high-impact biomanufacturing innovations that can be applied to current and future biopharmaceutical products, and to educate and train a world-leading workforce for the future of this industry. NIIMBL was formally established on March 1, 2017, by a $70 million collaborative agreement over five years from the National Institute for Standards and Technology (NIST), an institute that is part of the Department of Commerce.
Since its inception in FY 2017-18, the State of NC has provided $10 million in funding to be used as cost-share matches for NIIMBL projects being led by NC companies or academic institutions, and laboratory renovations necessary to carry out NIIMBL projects. These funds also helped to pay NIIMBL membership fees for small NC companies and community colleges. 33 different NC entities participate in NIIMBL, including 5 universities (ECU, NCCU, NC State, UNC-CH, and UNC-W), 12 community colleges, 15 small- and medium-sized companies (4 in Wilmington, 10 in RTP, and 1 in Charlotte), and 2 non-profit organizations. In the first six years of NIIMBL operations, NC members participated in projects totaling $25.6 million (federal funds, state funds, and other member cost share), including $9.3M of federal funds received by NC entities. Of the $9.3 million federal project support, $7.8 million went to NC Universities, $1.4 million went to small and medium-sized enterprises, and $100K went to NC non-profits. During the same six-year period, the $10 million in State cost share funds were utilized as follows: $5.5 million to NC Universities, $3.3 million for membership dues, travel awards, and program management, and $1.2 million for small and medium enterprises, community colleges, and non-profits. From 2017-2023, NC State University has received approximately $13.8 million in federal funding and $11.2 million in State cost share for project and operational expenditures.
The early support of the Kenan Institute for the BBDC program at BTEC played a key role in positioning BTEC to become a major player in biopharmaceutical manufacturing nationwide and taking a leadership position within NIIMBL. NIIMBL was funded for another five years in 2021 with a budget of $70 million from NIST, and an additional $83 million dollars from the ARP budget for COVID-19-related efforts. New efforts are under development in vaccine technologies, gene and cell therapy, applications of big data (Artificial Intelligence and Machine Learning) to biomanufacturing and process intensification and control. NIIMBL is scheduled for renewal in 2026 for another five years, but its future at this point is not clear.
The State of NC Legislature failed to provide additional continuing support for state-wide cost share of NIIMBL proposals, but NC State continues to provide cost share for projects being led by NC State investigators. On September 29, 2023, the Director of NIIMBL, Kelvin Lee, and other members of the NIIMBL leadership convened a group of NIIMBL members from NC at the North Carolina Biotechnology Center to discuss NIIMBL’s progress and future activities. Dr. Lee mentioned the critical role that NC State played in the proposal that led to the establishment of NIIMBL, and mentioned that without the efforts of KIETS Director, Dr. Ruben Carbonell, NIIMBL would not exist. On September 23, 2023, Kelvin Lee and other senior personnel at NIIMBL visited the NC Biotechnology Center to ensure that the strong collaborations with the State of NC continue. This was followed by a visit on March 29, 2024, to NC State and the laboratories of NC-VVIRAL to explore additional use of these facilities in NIIMBL-led projects. New NIIMBL proposals were funded in 2025 to Professor Stefano Menegatti in purification of viral vectors and to BTEC, for the development of novel educational programs. As of this writing, there are no indications of funding cuts to the Department of Commerce, which is the source of NIIMBL funding. KIETS is keeping a close eye on new developments on this issue. KIETS support is helping in the preparation of a new proposal to NIIMBL, dealing with the manufacturing of complex biologics in fungal cells. This technology has the potential to significantly reduce the cost and increase the productivity of the manufacturing of biopharmaceuticals.