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
Washington, DC
www.nap.edu
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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.
International Standard Book Number-13: 978-0-309-48781-8
International Standard Book Number-10: 0-309-48781-1
Digital Object Identifier: https://doi.org/10.17226/25340
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Suggested citation: 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: https://doi.org/10.17226/25340.
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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
Acknowledgment 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 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:
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 considered. Responsibility for the final content rests entirely with the rapporteur and the National Academies.
Contents
Public–Private Partnerships to Help Realize the Promise of Continuous Manufacturing
The Future of Access to Medical Countermeasures
FDA’s Interest in Continuous Manufacturing
BUSINESS CASE FOR CONTINUOUS MANUFACTURING
Transforming Biopharmaceutical Production Through the Deployment of Next-Generation Biomanufacturing
Continuous Manufacturing for Large Molecule Drugs
Continuous Processing Beyond Financials
Fitting a Continuous Process into Existing Facilities
Intensification of a Multi-Product Perfusion Platform
Drivers, Challenges, and Implementation Solutions for Continuous Perfusion Manufacturing
Practical Considerations for Adoption
What Can Be Learned from the Chemical Industry
Drying Technologies to Stabilize Labile Molecules
Solutions to Continuous Biomanufacturing Challenges
Opportunities for Low-Cost Vaccine Manufacturing
A Case Study: Biologically Derived Medicines on Demand
Strategy for Implementing Real-Time Release Testing
Advancements Toward Real-Time Release
REGULATORY AND QUALITY ASPECTS OF CONTINUOUS MANUFACTURING