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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

Navigating the Manufacturing
Process and Ensuring the
Quality of Regenerative
Medicine Therapies

PROCEEDINGS OF A WORKSHOP

Ariel Markowitz-Shulman, Siobhan Addie, Meredith Hackmann,
Joe Alper, and Sarah H. Beachy, Rapporteurs

Forum on Regenerative Medicine

Board on Health Sciences Policy

Health and Medicine Division

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

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.

International Standard Book Number-13: 978-0-309-46647-9
International Standard Book Number-10: 0-309-46647-4
Digital Object Identifier: https://doi.org/10.17226/24913

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the manufacturing process and ensuring the quality of regenerative medicine therapies: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24913.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

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The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

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Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

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Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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PLANNING COMMITTEE ON NAVIGATING THE MANUFACTURING PROCESS AND ENSURING THE QUALITY OF REGENERATIVE MEDICINE THERAPIES1,2

STEVEN OH (Co-Chair), Acting Deputy Director, Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

CLAUDIA ZYLBERBERG (Co-Chair), Founder and Chief Executive Officer, Akron Biotech

JAMES BECK, Vice President, Scientific Affairs, Parkinson’s Disease Foundation

RACHEL HADDOCK, Vice President, GMP Operations, Cell and Gene Therapy, GlaxoSmithKline

CATO T. LAURENCIN, Director, Institute for Regenerative Engineering; Chief Executive Officer, Connecticut Institute for Clinical and Translational Science; Distinguished Professor of Orthopedic Surgery and Chemical, Material and Biomolecular Engineering, University of Connecticut Health Center

THOMAS PETERSEN, Vice President, Regenerative Medicine, United Therapeutics Corporation

ANNE PLANT, Chief of the Biosystems and Materials Division, National Institute of Standards and Technology

JAMES RICHARDSON, Deputy Chief, Preclinical Translational Research Programs, Foundation Fighting Blindness

KRISHNENDU ROY, Robert A. Milton Chair and Professor Technical Lead, National Cell Manufacturing Consortium, Georgia Institute of Technology

KRISHANU SAHA, Assistant Professor, Department of Biomedical Engineering, Wisconsin Institute for Discovery, University of Wisconsin–Madison

MARTHA SOMERMAN, Director, National Institute of Dental and Craniofacial Research, National Institutes of Health

JIWEN ZHANG, Senior Director, Regulatory Affairs, Cell Therapy and Regenerative Medicine, GE Healthcare

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

2 Affiliation listed at the time of the workshop.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

Health and Medicine Division Staff

SARAH H. BEACHY, Project Director

ARIEL MARKOWITZ-SHULMAN, Associate Program Officer

SIOBHAN ADDIE, Program Officer

MEREDITH HACKMANN, Research Associate

HILARY BRAGG, Program Coordinator (until August 2017)

ANDREW M. POPE, Director, Board on Health Sciences Policy

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

FORUM ON REGENERATIVE MEDICINE1,2

R. ALTA CHARO (Co-Chair), Warren P. Knowles Professor of Law and Bioethics, School of Law and School of Medicine and Public Health, University of Wisconsin–Madison

JAY P. SIEGEL (Co-Chair), Chief Biotechnology Officer and Head, Scientific Strategy and Policy, Johnson & Johnson

JAMES C. BECK, Vice President, Scientific Affairs, Parkinson’s Disease Foundation

SANGEETA BHATIA, John J. and Dorothy Wilson Professor, Institute for Medical Engineering and Science, Electrical Engineering and Computer Science, Massachusetts Institute of Technology

LUCIE BRUIJN, Chief Scientist, The ALS Association

GEORGE Q. DALEY, Director, Stem Cell Transplantation Program, Boston Children’s Hospital and Dana-Farber Cancer Institute; Dean, Harvard Medical School

CYNTHIA DUNBAR, President, American Society of Gene & Cell Therapy

BRIAN FISKE, Senior Vice President, Research Programs, The Michael J. Fox Foundation for Parkinson’s Research

LAWRENCE GOLDSTEIN, Distinguished Professor, Department of Cellular and Molecular Medicine, Department of Neurosciences; Director, University of California, San Diego, Stem Cell Program; Scientific Director, Sanford Consortium for Regenerative Medicine; Director, Sanford Stem Cell Clinical Center, University of California, San Diego, School of Medicine

SUSAN HOWLEY, Executive Vice President, Research, Christopher & Dana Reeve Foundation

ROSEMARIE HUNZIKER, Director of Tissue Engineering and Regenerative Medicine, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health

SEIGO IZUMO, Global Head, Regenerative Medicine, Takeda Pharmaceuticals International, Inc.

RUSSELL KELLEY, Program Officer, Interfaces in Science and Regulatory Science, Burroughs Wellcome Fund

AUDREY KUSIAK, Scientific Program Manager, Rehabilitation Research and Development Service, Office of Research and Development, Department of Veterans Affairs

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

2 Affiliation listed at the time of the workshop.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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ROBERT S. LANGER, David H. Koch Institute Professor, Massachusetts Institute of Technology

CATO T. LAURENCIN, Director, Institute for Regenerative Engineering; Chief Executive Officer, Connecticut Institute for Clinical and Translational Science; Distinguished Professor of Orthopedic Surgery and Chemical, Material and Biomolecular Engineering, University of Connecticut Health Center

JOHN LEPORE, Senior Vice President, Research and Development Pipeline, GlaxoSmithKline

MARTHA LUNDBERG, Program Director, Division of Cardiovascular Sciences, Advanced Technologies and Surgery Branch, National Heart, Lung, and Blood Institute, National Institutes of Health

TERRY MAGNUSON, Sarah Graham Kenan Professor, Vice Chancellor for Research, University of North Carolina at Chapel Hill

MICHAEL MAY, President and Chief Executive Officer, Centre for Commercialization of Regenerative Medicine

DAVID OWENS, Acting Deputy Director, Division of Extramural Research, National Institute of Neurological Disorders and Stroke, National Institutes of Health

DIANA PANEKVICH, Director, Science Policy and Advocacy, Pfizer Inc.

DUANQING PEI, Director General, Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences

THOMAS PETERSEN, Vice President, Regenerative Medicine, United Therapeutics Corporation

ANNE PLANT, Chief of the Biosystems and Materials Division, National Institute of Standards and Technology

HEATHER ROOKE, Scientific Director, International Society for Stem Cell Research

STEPHEN ROSE, Chief Research Officer, Foundation Fighting Blindness

KRISHNENDU ROY, Robert A. Milton Chair in Biomedical Engineering; Technical Lead, National Cell Manufacturing Consortium; Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology

KRISHANU SAHA, Assistant Professor, Department of Biomedical Engineering, Wisconsin Institute for Discovery, University of Wisconsin–Madison

ELIZABETH SMITH, Senior Vice President of Regulatory and Quality Assurance, Juno Therapeutics, Inc.

MARTHA SOMERMAN, Director, National Institute of Dental and Craniofacial Research, National Institutes of Health

SOHEL TALIB, Scientific Program Officer, California Institute for Regenerative Medicine

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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SHARON TERRY, President and Chief Executive Officer, Genetic Alliance

MICHAEL WERNER, Executive Director, Alliance for Regenerative Medicine

CELIA WITTEN, Deputy Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

MICHAEL YAFFE, Vice President, Scientific Programs, The New York Stem Cell Foundation

JIWEN ZHANG, Senior Director, Regulatory Affairs, Cell Therapy and Regenerative Medicine, GE Healthcare

CLAUDIA ZYLBERBERG, Founder and Chief Executive Officer, Akron Biotech

Forum on Regenerative Medicine Staff

SARAH H. BEACHY, Project Director

ARIEL MARKOWITZ-SHULMAN, Associate Program Officer

SIOBHAN ADDIE, Program Officer

MEREDITH HACKMANN, Research Associate

REBECCA RAY, Senior Program Assistant (from August 2017)

HILARY BRAGG, Program Coordinator (until August 2017)

ANDREW M. POPE, Director, Board on Health Sciences Policy

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

STEWART ABBOT, Fate Therapeutics

THOMAS BOLLENBACH, Advanced Regenerative Manufacturing Institute

JOSEPH GOLD, City of Hope

JAMES RICHARDSON, Foundation Fighting Blindness

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by HAROLD J. FALLON, Medical University of South Carolina. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

Acknowledgments

The support of the sponsors of the Forum on Regenerative Medicine was crucial to the planning and conduct of the workshop, Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies, and for the development of this Proceedings of a Workshop. Federal sponsors were the Department of Veterans Affairs; National Institute of Standards and Technology; National Institutes of Health: 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; National Institute of Neurological Disorders and Stroke; and U.S. Food and Drug Administration. Nonfederal sponsorship was provided by Akron Biotech; Alliance for Regenerative Medicine; The ALS Association; American Society of Gene & Cell Therapy; Burroughs Wellcome Fund; California Institute for Regenerative Medicine; Centre for Commercialization of Regenerative Medicine; Christopher & Dana Reeve Foundation; Foundation Fighting Blindness; GE Healthcare; GlaxoSmithKline; International Society for Stem Cell Research; Johnson & Johnson; Juno Therapeutics, Inc.; The Michael J. Fox Foundation for Parkinson’s Research; The New York Stem Cell Foundation; Parkinson’s Disease Foundation; Pfizer Inc.; Takeda Pharmaceuticals U.S.A., Inc.; and United Therapeutics Corporation.

The Forum on Regenerative Medicine wishes to express gratitude to the expert speakers who explored the opportunities and challenges associated

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

with manufacturing regenerative medicine therapies and related technologies. The forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda. The project director would like to thank the project staff who worked diligently to develop both the workshop and the resulting Proceedings of a Workshop.

Page xviii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
×

Acronyms and Abbreviations

aHSCT

autologous hematopoietic stem cell transplantation

ALL

acute lymphocytic leukemia

ARMI

Advanced Regenerative Manufacturing Institute

BLA

biologics license application

CAR

chimeric antigen receptor

CFR

Code of Federal Regulations

CMC

chemistry, manufacturing, and control

CQA

critical quality attribute

FDA

U.S. Food and Drug Administration

FIRST

For Inspiration and Recognition of Science and Technology

GMP

good manufacturing practice

HIV

human immunodeficiency virus

HLA

human leukocyte antigen

IND

investigational new drug

IP

intellectual property

iPSC

induced pluripotent stem cell

ISBT

Information Standard for Blood and Transplant

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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MS

multiple sclerosis

MSC

mesenchymal stem/stromal cell

NEDA

no evidence of disease activity

NIIMBL

National Institute for Innovation in Manufacturing Biopharmaceuticals

NIST

National Institute of Standards and Technology

RCR

replication competent retroviral

STEM

science, technology, engineering, and mathematics

URS

user requirement specification

USP

U.S. Pharmacopeia

WHO

World Health Organization

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24913.
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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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