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Continuous Manufacturing for the Modernization of Pharmaceutical Production : Proceedings of a Workshop

By: (Author) Board on Chemical Sciences and Technology , (Author) Division on Earth and Life Studies , (Author) and Medicine National Academies of Sciences Engineering , (Edited by) Joe Alper

Extended Catalogue

Ksh 11,700.00

Format: Paperback or Softback

ISBN-10: 0309487811

ISBN-13: 9780309487818

Publisher: National Academies Press

Imprint: National Academies Press

Country of Manufacture: GB

Country of Publication: GB

Publication Date: Apr 5th, 2019

Print length: 68 Pages

Product Classification: Medicine

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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. 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

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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