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.
Board on Chemical Sciences and Technology & Division on Earth and Life Studies
Continuous Manufacturing for the Modernization of Pharmaceutical Production [EPUB ebook]
Proceedings of a Workshop
Continuous Manufacturing for the Modernization of Pharmaceutical Production [EPUB ebook]
Proceedings of a Workshop
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Ngôn ngữ Anh ● định dạng EPUB ● Trang 68 ● ISBN 9780309487849 ● Biên tập viên Joe Alper ● Nhà xuất bản National Academies Press ● Được phát hành 2019 ● Có thể tải xuống 3 lần ● Tiền tệ EUR ● TÔI 7145746 ● Sao chép bảo vệ Adobe DRM
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