The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
This book since first published in 2004 has been a major resource providing insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceuticals (recombinant protei
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Third Edition
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
John Geigert
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Third Edition
John Geigert BioPharmaceutical Quality Solutions Carlsbad, CA, USA
Originally Published with the title: “The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biosimilars” ISBN 978-3-030-13753-3 ISBN 978-3-030-13754-0 (eBook) https://doi.org/10.1007/978-3-030-13754-0 Library of Congress Control Number: 2019934774 © Springer Nature Switzerland AG 2004, 2013, 2019 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Preface
If you are humble, nothing will touch you, neither praise nor disgrace, because you know what you are. Mother Teresa, Missionaries of Charity in Calcutta, India, 1910–1997
Preparing the third edition of my book was a most humbling experience for me. My primary purpose for updating the second edition was to continue to provide relevant insight and practical suggestions for a risk-managed, common-sense, practical business approach to managing the chemistry, manufacturing, and controls (CMC) regulatory compliance requirements and expectations for biopharmaceuticals as human medicinal products. But the scope of this approach was almost overwhelming as there was so much that could not be included in the updated edition. Also, the more I evaluated what to include in the updated edition, the more I realized how little I really understood about everything that has occurred over the past 5 years, and continuing to occur, in this field of biopharmaceuticals. I trust that my choices will be of the most benefit. The magazi
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