Navigating the manufacturing process and ensuring the quality of regenerative medicine therapies : proceedings of a workshop / Ariel Markowitz-Shulman, Sioghan Addie, Meredith Hackmann, Joe Alper, and Sarah H. Beachy, rapporteurs ; Forum on Regenerative Medicine, Board on Health Sciences Policy, Health and Medicine Division, the National Academies of Sciences, Engineering, Medicine

Author: Markowitz-Shulman, Ariel
Published: Washington, DC : National Academies Press, [2017]
Physical Description: 1 online resource (1 PDF file (xx, 104 pages)) : illustrations
Additional Creators: Addie, Siobhan, Hackmann, Meredith, Alper, Joe, Beachy, Sarah H., and National Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Regenerative Medicine

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Contents

Transitioning from discovery and development to manufacturing -- Identifying and measuring critical quality attributes -- Designing technologies to meet the manufacturing needs of new regenerative medicine therapies -- Considerations for improving and regulating regenerative medicine products -- Potential next steps for supporting the development, manufacture, and regulation of regenerative medicine therapies.

Summary

On June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes. The workshop also addressed the challenges of designing and adhering to standards as a way of helping those who are working to scale up processes and techniques from a research laboratory to the manufacturing environment. This publication summarizes the presentations and discussions from the workshop.

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ISBN

9780309466486
0309466482
9780309466479
0309466474

Bibliography Note

Includes bibliographical references.

Funding Information

This project was supported by contracts between the National Academy of Sciences and Akron Biotech (unnumbered contract); Alliance for Regenerative Medicine (unnumbered contract); The ALS Association (unnumbered contract); American Society of Gene & Cell Therapy (unnumbered contract); Burroughs Wellcome Fund (Grant #1015949); California Institute for Regenerative Medicine (unnumbered contract); Centre for Commercialization of Regenerative Medicine (unnumbered contract); Christopher & Dana Reeve Foundation (unnumbered contract); Department of Veterans Affairs (Contract No. VA268-16-C-0051); Foundation Fighting Blindness (unnumbered contract); GE Healthcare (unnumbered contract); GlaxoSmithKline (Grant ID: 015948); International Society for Stem Cell Research (unnumbered contract); Johnson & Johnson (unnumbered contract); Juno Therapeutics, Inc. (unnumbered contract); The Michael J. Fox Foundation for Parkinson's Research (unnumbered contract); National Institute of Standards and Technology (unnumbered contract); National Institutes of Health (Contract No. HHSN263201200074I, Order No. HHSN23600075: National Heart, Lung, and Blood Institute; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Biomedical Imaging and Bioengineering; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; and National Institute of Neurological Disorders and Stroke); The New York Stem Cell Foundation (unnumbered contract); Parkinson's Disease Foundation (unnumbered contract); Pfizer Inc. (unnumbered contract); Takeda Pharmaceuticals U.S.A., Inc. (Contract #65317); United Therapeutics Corporation (unnumbered contract); and U.S. Food and Drug Administration (Grant #1R13FD005355-01). Any opinions, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

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