Continuous Manufacturing for the Modernization of Pharmaceutical Production

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Continuous Manufacturing for the Modernization of Pharmaceutical Production is written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. It's available with International Standard Book Number or ISBN identification 0309487811 (ISBN 10) and 9780309487818 (ISBN 13).

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.