Completed
This public workshop explored challenges and opportunities in manufacturing regenerative medicine therapeutics as the field evolves to accommodate higher volume production and increased capacity for delivering regenerative medicine treatments to patients. Presentations and discussions considered how new developments in areas such as closed systems, decentralized manufacturing, and automation can affect manufacturing cell- or gene-based therapies.
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Workshop_in_brief
·2024
As the number of regenerative medicines and therapies approved by the Food and Drug Administration (FDA) has grown to meet rising demand, the field of regenerative medicine has started to anticipate the potential of strategies such as artificial intelligence, decentralized manufacturing, and automat...
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Description
A planning committee of the National Academies of Sciences, Engineering, and Medicine will organize and hold a one-day public workshop to examine challenges and opportunities in manufacturing regenerative medicine therapeutics as the field evolves to accommodate higher volume production and increased capacity for delivering regenerative medicine treatments to patients. The workshop will explore how new scientific advancements and technological developments in manufacturing cell- and gene-based therapies are shaping the maturing industry of regenerative medicine.
Workshop presentations and discussions may address some of the following topics:
• New developments in closed systems for bioprocessing and biomanufacturing
• Decentralized manufacturing as a strategy to address production and supply chain challenges for regenerative medicine treatments
• Automation, data analysis, computational modeling, and artificial intelligence/machine learning algorithms for advanced biomanufacturing
• Open-source manufacturing to facilitate knowledge sharing and support technology transfer among organizations
• Quality control techniques to improve manufacturing reliability and regulatory strategies to sustainably increase biomanufacturing capacity
• Building multidisciplinary teams equipped to implement new manufacturing approaches and capitalize on the potential of recent developments
The planning committee will organize the workshop, develop the agenda, select and invite speakers, and moderate discussions. Proceedings-in-brief of the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.
Collaborators
Sponsors
Advanced Regenerative Manufacturing Institute
Akron Biotech
Alliance for Regenerative Medicine
American Society of Gene & Cell Therapy
Burroughs Wellcome Fund
California Institute for Regenerative Medicine
Centre for Commercialization of Regenerative Medicine
Department of Veterans Affairs
Food and Drug Administration
International Society for Cellular Therapy
International Society for Stem Cell Research
Johnson & Johnson
National Institute of Standards and Technology
National Institutes of Health
New York Stem Cell Foundation
United Therapeutics
Staff
Lydia Teferra
Samantha Schumm
Ashley Pitt