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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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John Geigert

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This book addresses the challenges of quality assurance/quality control (QA/QC) in the biopharmaceutical sector, emphasizing its strategic value in manufacturing. It discusses the need for a graded QA/QC approach from clinical trials to market approval and includes updates on new regulatory guidances and the development of biosimilars and other biologics.

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, John Geigert

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Released: 2016
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Title: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Language: English
Authors: John Geigert
Publisher: Springer / Springer New York / Springer, Berlin
Released: 2016
Format: Paperback
ISBN13: 9781493943999
Tags: Health & Medicine, Nature, Animals, Technology / Engineering, Nature
Rating: 4.75 out of 5
Description: This book addresses the challenges of quality assurance/quality control (QA/QC) in the biopharmaceutical sector, emphasizing its strategic value in manufacturing. It discusses the need for a graded QA/QC approach from clinical trials to market approval and includes updates on new regulatory guidances and the development of biosimilars and other biologics.