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Emerging Technologies and Innovation in Manufacturing Regenerative Medicine Therapies: A Workshop

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.

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

Committee

Co-Chair

Co-Chair

Member

Member

Member

Member

Member

Member

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

Sarah Beachy

Lead

SBeachy@nas.edu

Lydia Teferra

LTeferra@nas.edu

Samantha Schumm

SSchumm@nas.edu

Ashley Pitt

APitt@nas.edu

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