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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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Innovations in
PHARMACEUTICAL
MANUFACTURING
on the Horizon

Technical Challenges, Regulatory Issues,
and Recommendations

Committee to Identify Innovative Technologies to Advance
Pharmaceutical Manufacturing

Board on Chemical Sciences and Technology

Division on Earth and Life Studies

A Consensus Study Report of

images

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

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This project was supported by Contract 75F40119C10045 between the National Academies of Sciences, Engineering, and Medicine and the Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number-13: 978-0-309-08867-1
International Standard Book Number-10: 0-309-08867-4
Digital Object Identifier: https://doi.org/10.17226/26009

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Copyright 2021 by the National Academy of Sciences. All rights reserved.

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. https://doi.org/10.17226/26009.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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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. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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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.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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COMMITTEE TO IDENTIFY INNOVATIVE TECHNOLOGIES TO ADVANCE PHARMACEUTICAL MANUFACTURING1

Members

GINTARAS REKLAITIS (NAE) (Chair), Purdue University, IN

TIMOTHY CHARLEBOIS, Pfizer Inc, MA

MATTHEW DELISA, Cornell University, NY

CHRISTOPHER EARNHART, U.S. Army, Department of Defense, MD

STEPHEN W. HADLEY, Bill & Melinda Gates Foundation, WA

ARLENE JOYNER, U.S. Department of Health and Human Services, Washington, DC

KATHERINE LEWIS, Lawrence Livermore National Laboratory, CA

PAUL MORT, Purdue University, IN

TODD PRZYBYCIEN, Rensselaer Polytechnic Institute, NY

KELLEY ROGERS, National Institute of Standards and Technology, MD

SALY ROMERO-TORRES, Thermo Fisher Scientific, NC

GREGORY STEPHANOPOULOS (NAE), Massachusetts Institute of Technology, MA

SEONGKYU YOON, University of Massachusetts Lowell, MA

Staff

ELLEN K. MANTUS, Project Director

MARILEE SHELTON-DAVENPORT, Senior Program Officer

RADIAH ROSE-CRAWFORD, Manager, Editorial Projects

KESIAH CLEMENT, Senior Program Assistant

Sponsor

FOOD AND DRUG ADMINISTRATION

___________________

1 See Appendix B, Disclosure of Conflict(s) of Interest.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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BOARD ON CHEMICAL SCIENCES AND TECHNOLOGY

Co-Chairs

SCOTT COLLICK, DuPont

JENNIFER SINCLAIR CURTIS, University of California, Davis

Members

GERARD BAILLELY, Procter and Gamble

RUBEN G. CARBONELL (NAE), North Carolina State University

JOHN FORTNER, Yale School of Engineering and Applied Science

SAMUEL H. GELLMAN (NAS), University of Wisconsin-Madison

KAREN I. GOLDBERG (NAS), University of Pennsylvania

TIMOTHY HALL, McNesse State University

MIRIAM E. JOHN, Sandia National Laboratories (Ret.)

JODIE L. LUTKENHAUS, Texas A&M University

JOSEPH B. POWELL, Shell Global

PETER ROSSKY (NAS), Rice University

REBECCA T. RUCK, Merck Process Research & Development

RICHMOND SARPONG, University of California, Berkeley

VIJAY SWARUP, ExxonMobil

SALY ROMERO-TORRES, Thermo Fisher Scientific

Staff

JEREMY T. MATHIS, Board Director

ELLEN MANTUS, Scholar

MARILEE SHELTON-DAVENPORT, Senior Program Officer

MAGGIE WALSER, Senior Program Officer

NICHOLAS ROGERS, Financial Associate

JESSICA WOLFMAN, Research Associate

KESIAH CLEMENT, Senior Program Assistant

SARAH HARPER, Program Assistant

OLIVIA TORBERT, Program Assistant

BENJAMIN ULRICH, Program Assistant

ELISE ZAIDI, Communications & Media Associate

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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Acknowledgments

This Consensus Study Report was reviewed in draft form by persons 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 report as sound as possible and to ensure that it meets institutional standards of quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following for their review of this report:

Matthew Bio, Snapdragon Chemistry

Richard D. Braatz (NAE), Massachusetts Institute of Technology

Barry Coller (NAS/NAM), The Rockefeller University

Margaret Hamburg (NAM), National Academy of Medicine

Klavs Jensen (NAS/NAE), Massachusetts Institute of Technology

Christine Moore, Merck

Jean Tom (NAE), Bristol-Myers Squibb

Greg Troiano, BIND Therapeutics

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report, nor did they see the final draft before its release. The review of the report was overseen by Babatunde A. Ogunnaike (NAE) and Stephen W Drew (NAE) who were responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

The completion of this study would not have been successful without the assistance of many individuals and organizations. The committee thanks especially the following for their contributions: Noubar Afeyan, Flagship Pioneering; Karin Balss, Janssen; Akilesh Bhambhani, Merck; Dan Blackwood, Pfizer; Andy Bommarius, Georgia Institute of Technology; Richard Braatz, Massachusetts Institute of Technology; Jon Coffman, AstraZeneca; Paul Collins, Lilly; Mauricio Futran, Janssen; David Gaugh, Association for Accessible Medicines; Susan Hershenson, Bill & Melinda Gates Foundation; Jun Huang, Pfizer; Günter Jagschies, GE Healthcare (Retired); Amy Jenkins, Defense Advanced Research Projects Agency; Mansoor Khan, Texas A&M University; Michael Kopcha, Food and Drug Administration (FDA); Richard Korsmeyer, Consultant; Sau (Larry) Lee, FDA; David Lechuga-Ballesteros, AstraZeneca; Kelvin Lee, University of Delaware; Brent Lieffers, Singota Solutions; Kerry Love, Sunflower Therapeutics; Gustavo Mahler, Dynamk Capital; Salvatore Mascia, Continuus; Christine Moore, Merck; Steve Nail, Baxter; Roger Nosal, Pfizer; Gregg Nyberg, Merck; Lisa Parks, Association for Accessible Medicines; Jack Prior, Sanofi; Govind Rao, University of Maryland; John Schiel, National Institute of Standards and Technology; Patricia Seymour, BDO; Jason Starkey, Pfizer; Patrick Swann, Amgen; Jim Thomas, Just – Evotec Biologics; Jorg Thommes, Bill & Melinda Gates Medical Research Institute; Jean Tom, Bristol-Myers Squibb; Katherine Tyner, FDA; Kim Wolfram, Biogen; Janet Woodcock, FDA; Jae Yoo, Aprecia; and Ping Zhao, Bill & Melinda Gates Foundation.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, flexible pharmaceutical manufacturing sector. The goal was to encourage a transition to manufacturing processes and approaches that could produce high-quality drugs reliably without extensive regulatory oversight. Much progress has been made toward that goal as the industry has developed and advanced new technologies, but more progress is required as recent natural disasters and the coronavirus pandemic have revealed vulnerabilities in supply chains and highlighted the need to modernize pharmaceutical manufacturing further.

At the request of the FDA Center for Drug Evaluation and Research (CDER), Innovations in Pharmaceutical Manufacturing on the Horizon identifies emerging technologies - such as product technologies, manufacturing processes, control and testing strategies, and platform technologies - that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by CDER. This report describes many innovations to modernize the manufacture of drug substances and drug products, to advance new control approaches, and to develop integrated, flexible, and distributed manufacturing networks within 5-10 years.

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