The third annual AIM-Bio Biopharmaceutical Manufacturing Symposium, which was held at NC State University Nov. 9–11, 2022, was attended by over 80 people. Participating were individuals from NC State, the Technical University of Denmark (DTU), and the Novo Nordisk Foundation; members of the program’s external advisory board; and speakers from industry and academia. The goals of the meeting were to:
- increase understanding of program activities and increase engagement and collaboration among program participants,
- enhance the group’s knowledge of the challenges and latest thinking in the area of biopharmaceutical manufacturing, and
- provide networking opportunities among participants.
To enhance knowledge of biopharmaceutical manufacturing, the first day of the meeting included three keynote speakers and five moderated interview sessions with experts in the field.
Laura Niklason, PhD, MD, who is the founder, president, and chief executive officer of Humacyte, kicked off the meeting with an informative talk on “Bioengineering Human Tissue Replacements from Scratch.” Next, Charles Houston Jones, PhD, senior director of mRNA Commercial Strategy and Innovation at Pfizer, discussed the importance of mRNA as part of a therapeutic revolution. His talk focused on RNA-based technology platforms and how this technology is undergoing rapid evolution following the success of the COVID-19 vaccines. The third keynote speaker, Juan Torres, PhD, spoke on “Innovation Trends in the Quality Oversight of Biopharmaceutical Manufacturing.” His talk focused on the importance of advances in analytical technology, artificial intelligence, and machine learning for innovation in the oversight of pharmaceutical product quality. Dr. Torres served as the chief quality officer at Biogen until his retirement in 2021 and now serves as president of Ingenuitas , a non-profit organization. He also holds the position of Senior Fellow with NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals.
The symposium agenda also included five moderated interview sessions with industry experts. Each interviewee presented a short overview of their topic, followed by discussion with the symposium audience. This innovative format provided the opportunity for increased interaction between the speakers and audience. The fast pace of the sessions and the variety of topics addressed resulted in enthusiastic discussion and a high level of engagement.
The interview sessions included the following speakers and topics:
- Sean Neally, CMRP: Challenges of a Large API Manufacturing Site
- Deenesh K. Babi, PhD: Digital Twins – A Buzzword for Unit or Process Models or Is There More to It?
- Ke Cheng, PhD: Exosomes as the Next Generation Drug Carriers
- Michael Guerrero, PhD: Efficiency/Fidelity of rAAV Packaging
- Carol Hall, PhD: Computational Design of Peptides asBiomarkers, Sensors and Drugs
Mr. Neally is director of Production Support, Novo Nordisk, Clayton, N.C., and Dr. Babi is a senior project manager with Novo Nordisk, Copenhagen. Dr. Ke Cheng is the Randall B. Terry, Jr. Distinguished Professor of Regenerative Medicine at NC State University. Dr. Michael Guerrero is head of Technical Development, BridgeBio, Raleigh, and Dr. Carol Hall is the Camille Dreyfus Distinguished University Professor in NC State’s Department of Chemical and Biomolecular Engineering.
