On August 6, NIIMBL held its latest technology workshop, Cell Therapy Manufacturing Innovation. Hosted by Celgene at its facility in Summit, N.J., the workshop brought together more than 90 participants from industry, academia, and federal agencies. The participants represented more than 50 unique organizations.
The day-long workshop began with remarks and a NIIMBL update from Chief Technology Officer Ruben Carbonell. Presentations from Greg Russotti and Chris Ramsborg of Celgene and Patrick Sullivan of MilliporeSigma focused on industry needs for cell therapy and vector manufacturing. The agenda also featured regulatory perspectives as Mercy Quagraine of the FDA presented on regulatory considerations for releasing cell therapy products.
Breakout sessions focused on four key themes pertinent to cell therapy manufacturing:
- Manufacturing platforms for cell therapy products, including vector production
- Novel methods for characterizations of live cell products
- Improved cryopreservation or cell preservation technologies
- Regulatory issues: process validation, product release
The event was NIIMBL’s third technology workshop this year. It following workshops on biologic process innovations in April and process analytical technology, modeling, and control in May.
The next Technology Workshop, Adventitious Agents Detection Methods and Control, will be hosted by Merck & Company on October 22.
“These technology workshops have provided an extremely valuable forum to bring the community together and stimulate meaningful discussions around key topics in biopharmaceutical manufacturing. We would like to thank the NIIMBL community and our hosts, Celgene, for a successful event,” said Ruben Carbonell, NIIMBL Chief Technology Officer.
NIIMBL members can view presentations from the workshop on the workshop webpage. Log in is required to view the materials.
Registration is now open Adventitious Agents Detection Methods and Control Technology Workshop hosted by Merck & Co. at its Kenilworth, NJ facility on October 22. Technology Workshops are open to NIIMBL members only. Registration closes October 10.
For more information on how your organization can get involved with NIIMBL, please visit https://niimbl.force.com/s/membership-information.