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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25340.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25340.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25340.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25340.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25340.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25340.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25340.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25340.
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PREPUBLICATION COPY Continuous Manufacturing for the Modernization of Pharmaceutical Production PROCEEDINGS OF A WORKSHOP Joe Alper, Rapporteur Board on Chemical Sciences and Technology Division on Earth and Life Studies

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by Contract/Grant No. HHSP233201400020B between the National Academy of Sciences and the Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. Digital Object Identifier: https://doi.org/10.17226/25340 Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-331 3; http://www.nap.edu. Copyright 2019 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manu- facturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25340. Prepublication Copy

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. The National Academy of Engineering was established in 1964 under the charter of the Na- tional Academy of Sciences to bring the practices of engineering to advising the nation. Mem- bers are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.na- tionalacademies.org. Prepublication Copy

Consensus Study Reports published by the National Academies of Sciences, Engineer- ing, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclu- sions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independ- ent 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 Medi- cine 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. Prepublication Copy

PLANNING COMMITTEE FOR A WORKSHOP ON CONTINUOUS MANUFACTURING FOR THE MODERNIZATION OF PHARMACEUTICAL PRODUCTION Members GINTARAS V. REKLAITIS (Chair), Purdue University LIUQUAN CHANG, Merck CHARLES COONEY, Massachusetts Institute of Technology EVA GEFROH, Just Biotherapeutics KEN LEE, MedImmune KEITH ROPER, University of Arkansas Staff ELIZABETH BOYLE, Program Officer MARILEE SHELTON-DAVENPORT, Senior Program Officer ANNA SBEREGAEVA, Associate Program Officer JARRETT NGUYEN, Senior Program Assistant Consultant JOE ALPER, Rapporteur Prepublication Copy v

Acknowledgement of 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 crit- ical 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: Rubin Carbonell, North Carolina State University Eva Gefroh, Just Biotherapeutics Mike Ladisch, Purdue University 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 Stephen W. Drew, Drew Solutions LLC. 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 consid- ered. Responsibility for the final content rests entirely with the rapporteur and the National Academies. vi Prepublication Copy

Contents INTRODUCTION .............................................................................................................................................. 1 Public–Private Partnerships to Help Realize the Promise of Continuous Manufacturing, 1 The Future of Access to Medical Countermeasures, 3 FDA’s Interest in Continuous Manufacturing, 4 BUSINESS CASE FOR CONTINUOUS MANUFACTURING ..................................................................... 5 Transforming Biopharmaceutical Production Through the Deployment of Next-Generation Biomanufacturing, 5 Continuous Manufacturing for Large Molecule Drugs, 6 Continuous Processing Beyond Financials, 7 UPSTREAM PROCESSING ............................................................................................................................. 8 Fitting a Continuous Process into Existing Facilities, 8 Intensification of a Multi-Product Perfusion Platform, 9 Drivers, Challenges, and Implementation Solutions for Continuous Perfusion Manufacturing, 10 DOWNSTREAM PROCESSING.................................................................................................................... 11 Practical Considerations for Adoption, 11 What Can Be Learned from the Chemical Industry, 12 Turning Concept into Reality, 13 PRODUCT MANUFACTURING ................................................................................................................... 13 Drying Technologies to Stabilize Labile Molecules, 13 Solutions to Continuous Biomanufacturing Challenges, 14 Opportunities for Low-Cost Vaccine Manufacturing, 16 INTEGRATION................................................................................................................................................ 17 A Case Study: Biologically Derived Medicines on Demand, 17 Strategy for Implementing Real-Time Release Testing, 18 Advancements Toward Real-Time Release, 19 REGULATORY AND QUALITY ASPECTS OF CONTINUOUS MANUFACTURING ........................ 20 Key Aspects of Regulation, 20 Considerations for Virus Clearance Validation, 22 Considerations for Integrated Biomanufacturing, 23 REPORTS FROM SIX BREAKOUT SESSIONS ......................................................................................... 24 Breakout Group 1: The Business Case, 24 Breakout Group 2: Upstream Processing, 25 Breakout Group 3: Downstream Processing, 26 Breakout Group 4: Product Manufacturing, 27 Breakout Group 5: Integration, 27 Breakout Group 6: Regulatory and Quality Aspects of Continuous Manufacturing, 28 REFERENCES ................................................................................................................................................. 29 Prepublication Copy vii

APPENDIXES A WORKSHOP AGENDA ........................................................................................................................... 31 B BIOGRAPHIES OF PLANNING COMMITTEE MEMBERS, SPEAKERS, AND NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE STAFF............... 33 C RUNNING THEMES ACROSS WORKSHOP SESSIONS .................................................................. 40 viii Prepublication Copy

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On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.

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