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.Table of ContentsFront MatterProceedings of a WorkshopAppendix A: Workshop AgendaAppendix B: Biographies of Planning Committee Members, Speakers, and National Academies of Sciences, Engineering, and Medicine StaffAppendix C: Running Themes Across Workshop Sessions
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Produktdetaljer

ISBN
9780309487818
Publisert
2019-04-05
Utgiver
Vendor
National Academies Press
Høyde
229 mm
Bredde
152 mm
Aldersnivå
P, 06
Språk
Product language
Engelsk
Format
Product format
Heftet
Antall sider
68

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