Title: Continuous Manufacturing for the Modernization of Pharmaceutical Production
Publisher: National Academies Press
Publication Date: 2019
Language: English
ISBN 10: 0309487811
ISBN 13: 9780309487818
Binding: PAP
Condition: New
Weight: 277 grams

About this title

Synopsis

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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