Volume 1, Issue 1, February 2021
BMIG launches, seeks members
The Biopharmaceutical Manufacturing Interest Group (BMIG) was launched in December 2020 with its virtual kickoff meeting attended by nearly 50 participants from multiple departments, colleges and industry. The event featured presentations by the BMIG leadership team, followed by a short discussion.
In a video message, Associate Vice Chancellor Dr. Jonathan Horowitz emphasized NC State’s leadership and longstanding research focus on advanced manufacturing. Citing the significance of the biopharma manufacturing industry to the state’s economy and revenue, Dr. Horowitz highlighted NC State’s affiliations with Manufacturing USA national institutes specifically — the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and Bioindustrial Manufacturing and Design Ecosystem (BioMADE) — and noted their relevance to biopharmaceutical manufacturing.
Dr. Ruben Carbonell, director of NC State’s William R. Kenan, Jr. Institute for Engineering, Technology and Science and senior technology strategist for NIIMBL, presented the opportunities and challenges in upstream and downstream processes and new approaches in biopharmaceutical manufacturing. He also highlighted the various NIIMBL-led research programs on industry-relevant areas, such as process intensification, big data, vaccine manufacturing and gene therapy.
Dr. Gary Gilleskie, executive director of Biomanufacturing Training and Education Center (BTEC), presented an overview of BTEC and highlighted its industry-relevant process and analytical equipment that can be used for research and workforce training. Dr. Jennifer Pancorbo, BTEC’s director of Industry Programs and Research, highlighted the center’s bioprocess service capabilities, research initiatives and collaborations.
In addition to spotlighting centers and core research facilities within NC State that can be leveraged for biopharmaceutical manufacturing research, the event featured organizations within North Carolina — specifically, the North Carolina Biotechnology Center (NCBC) and the North Carolina Biosciences Organization (NCBIO) — that are instrumental in fostering biopharmaceutical manufacturing research. For more information, visit the BMIG website (https://bmig.ncsu.edu/), and consider registering to join the group. Members are notified of opportunities to collaborate on biomanufacturing research grants and participate in events.
NC State's partnership with Manufacturing USA
Manufacturing USA was established in 2014 to ensure America’s position as a global leader in advanced manufacturing, innovation, collaboration and to accelerate workforce development nationwide. Manufacturing USA consists of a national network of 16 linked manufacturing institutes. Designed to accelerate advanced manufacturing as a whole at the national level, each institute has a unique technological focus such as biotechnology, sustainable manufacturing, artificial intelligence, bioindustrial manufacturing, automation, and sensors to list a few out of the many. NC State is directly involved in eight of the 16 Manufacturing USA institutes — more than any other university in the country. Owing to NC State’s well established leadership, interest and success in manufacturing technologies, partnerships with Manufacturing USA institutes bring immense benefits in the form of increased collaborations and research grants; innovation and new technologies; training and skills development; and recruitment of research and entrepreneurial talent. Thus also contributing directly to the revenue and the economic growth of the State of North Carolina.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
NIIMBL is one of the 16 institutes in the Manufacturing USA network. NIIMBL is a public-private partnership dedicated to advancing manufacturing innovation and workforce development in biopharmaceutical manufacturing. NIIMBL partners with universities, industries, federal agencies, and non-profit organizations to accelerate biopharmaceutical manufacturing innovation, support the development of standards that enable more efficient and rapid manufacturing, and educate and train a world-leading biopharmaceutical manufacturing workforce nation-wide. NC State University is a Tier 1 academic partner of NIIMBL, which allows it to secure grants for an unlimited number of projects.
NC State - NIIMBL projects
NC State continues to win multiple research awards from NIIMBL. Currently, NC State has secured funding through NIIMBL amounting to ~$3.8 million in funds towards research projects. Many of these are collaborations between multiple departments, such as Chemical and Biomolecular Engineering; Biomedical Engineering, and BTEC.
Most impressively, NC State faculty were able to quickly respond, compete and win research funds for the recent technology innovation projects announced in June 2020 to support the nation's response to the COVID-19 pandemic. The following two proposals were awarded with funds that NIIMBL received through the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
- The Nonwovens Institute has been awarded a grant for "Production N95 and Surgical Masks" under the leadership of Dr. Behnam Pourdeyhimi, Dr. Pierre Daniel Grondin, and Dr. Abhay Sham Joijode.
- The College of Business Management was awarded a grant for "Designing a Test Kit Supply Chain in Response to COVID19" under the leadership of Dr. Rob Handfield and Dr. Donald Warsing.
- “Single-use Modules for Continuous Removal of Antibody Fragments.”
- Led by Stefano Menegatti, Chemical and Biomolecular Engineering. Other collaborators from NC State are Dr. Gary Gilleskie, and Caroline Smith-Moore, both with BTEC.
- “Gene Therapy Training Network (GTTN) and Instructional Transfer Platform (ITP).”
- Led by Dr. Gary Gilleskie, BTEC.
- “Expanding AAV Process Characterization Analytical Technologies.”
- Led by Dr. Caroline Smith-Moore, Dr. Gary Gilleskie, BTEC; and Dr. Erin Baker, Department of Chemistry.
- “SPIDER Project 2.0.”
- Led by Dr. Ryan Barton, BTEC
- “A Multivariate In-Line Optochemical Sensor Platform for Continuous Monitoring of Cross-Category Process Parameters and Product Attributes in Bioreactors.”
- Led by Dr. Qingshan Wei, Dr. Jan Genzer, Dr. Balaji Rao, Department of Chemical and Biomolecular engineering; Dr. Frances Ligler, Joint Department of Biomedical Engineering; Dr. Michael Smith Kudenov, Electrical and Computer Engineering and Dr. Gary Gilleskie, BTEC.
- “Use of Carbon Thin Films to Reduce Leachable Contamination.”
- Led by Dr. Roger Jagdish Narayan, Biomedical Engineering.
- “Identification, Characterization and Removal of HCP in CHO Monoclonal Antibody Biomanufacturing Processes.”
- Led by Dr. Stefano Menegatti, Chemical and Biomolecular Engineering. Other collaborators are Dr. Gary Gilleskie, Dr. Caroline Smith-Moore, BTEC; and Dr. Taufika Williams, Department of Chemistry.
Bioindustrial Manufacturing and Design Ecosystem BioMADE
NC State University is a founding member of BioMADE. Established by the Engineering Biology Research Consortium (EBRC), BioMADE joins eight DoD-sponsored Manufacturing Innovation Institutes (MII) as part of the Manufacturing USA network. BioMade functions to create an end-to-end, sustainable, reusable ecosystems for domestic manufacturing through manufacturing innovation, education, and collaboration. We can look forward to some exciting new and innovative research collaborations in the near future!
Upcoming events and registration
Mark your calendars to join us in March and April for two upcoming talks by world-leading experts in mRNA vaccines and coronavirus. Given the current COVID-19 pandemic, it cannot be more appropriate to learn about mRNA vaccines and therapeutic developments for coronaviruses.
- Dr. Philippe-Alexandre Gilbert, with the Bill and Melinda Gates Foundation, will speak on “The key role of Bill & Melinda Gates Foundation (BMGF) in vaccine technology development: an overview” from 11:00 a.m.–12:00 p.m. March 26, 2021.
- Dr. Timothy Sheahan, Assistant Professor in Epidemiology, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, will present “Preparing for tomorrow’s pandemics today: Accelerating therapeutic development with preclinical models of coronavirus pathogenesis” from 10:40 a.m.–11:30 a.m. April 23, 2021.
Registration information will be emailed to BMIG members soon. The lectures will take place online.
Funding opportunity announcement
Future Manufacturing (FM). NSF Program solicitation: NSF 21-564 “The goal of the Future Manufacturing program is to support fundamental research and education that will enable new manufacturing approaches to eliminate scientific technological, educational, economic and social barriers that limit current manufacturing. Future Manufacturing will complement existing efforts, supported by NSF and other federal agencies, in advanced manufacturing, but the focus of this program is to enable new, potentially transformative, manufacturing capabilities rather than to improve current manufacturing”. Click here for more information: HTML PDF
Centennial Biomedical GMP Facility
The Comparative Medicine Institute’s Centennial Biomedical GMP facility is a 640-square-foot, ISO 7 cleanroom facility designed and established for enabling Phase I, first in human, clinical trials. The clinical manufacturing facility provides members from both the academia and the industry with flexibility and affordability while maintaining the highest quality at all times, making it an ideal choice for early startups. The facility supports GMP protocols, including those with an active Investigational New Drug (IND) or equivalent. The GMP facility has four modules and houses several pieces of GMP equipment such as incubators, cell counters, centrifuges, and microscopes. In addition, the facility also houses QC lab equipment such as a PCR thermocycler, gel imaging system, and flow cytometry, which are available to users. Key capabilities at Centennial Biomedical GMP facility include the ability to produce novel products under controls consistent with U.S. FDA current Good Manufacturing Practices (cGMP) — isolation and expansion of human cells, and manipulation of human cells under cGMP controls for use in Phase I, first in human, clinical trials. Along with the above mentioned capabilities, there are additional benefits to partnering with the Centennial Biomedical GMP facility such as free training for startup employees to use the GMP facility, formatting cGMP compliant documents and many more. To learn more about the services offered by the Centennial Biomedical GMP facility please visit their website.