| Description |
1 online resource (1 PDF file (viii, 60 pages)) : illustrations |
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text file |
| Bibliography |
Includes bibliographical references. |
| Summary |
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. |
| Funding |
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. |
| Contents |
Intro; FrontMatter; Acknowledgment of Reviewers; Contents; Proceedings of a Workshop; Appendix A: Workshop Agenda; Appendix B: Biographies of Planning Committee Members, Speakers, and National Academies of Sciences, Engineering, and Medicine Staff; Appendix C: Running Themes Across Workshop Sessions |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
Pharmaceutical technology -- United States -- Congresses.
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Pharmaceutical technology. |
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United States. |
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Pharmaceutical industry -- United States -- Congresses.
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Pharmaceutical industry. |
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United States. |
| Genre/Form |
Congress.
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Conference papers and proceedings.
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Technical reports.
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Technical reports.
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Conference papers and proceedings.
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| Added Author |
National Academies of Sciences, Engineering, and Medicine (U.S.). Board on Chemical Sciences and Technology, issuing body.
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Continuous Manufacturing for the Modernization of Pharmaceutical Production (Workshop) (2018 : Washington, D.C.)
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| Other Form: |
Print version: Alper, Joe. Continuous manufacturing for the modernization of pharmaceutical production 0309487811 9780309487818 (OCoLC)1089776226 |
| ISBN |
9780309487818 |
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0309487811 |
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9780309487825 (electronic book) |
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030948782X (electronic book) |
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9780309487849 (electronic book) |
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0309487846 (electronic book) |
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