Quality by Design for Biopharmaceutical Drug Product Development
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key
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Volume 18
Series Editors Daan J. A. Crommelin Utrecht, Utrecht, The Netherlands Robert A. Lipper Back Cove Pharma, LLC, Waldoboro, Maine, USA
The AAPS Advances in the Pharmaceutical Sciences Series, published in partnership with the American Association of Pharmaceutical Scientists, is designed to deliver well written volumes authored by opinion leaders and authorities from around the globe, addressing innovations in drug research and development, and best practice for scientists and industry professionals in the pharma and biotech industries. More information about this series at http://www.springer.com/series/8825
Feroz Jameel • Susan Hershenson Mansoor A. Khan • Sheryl Martin-Moe Editors
Quality by Design for Biopharmaceutical Drug Product Development
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Editors Feroz Jameel Parenteral Product and Process Development Amgen Inc. Thousand Oaks California USA Susan Hershenson Bill and Melinda Gates Foundation, Chemistry, Manufacturing and Controls Seattle Washington USA
Mansoor A. Khan Division of Product Quality Research Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research and Office of Pharmaceutical Sciences Silver Spring Maryland USA Sheryl Martin-Moe Enterprise Catalyst Group Inc. Palo Alto California USA
ISSN 2210-7371 ISSN 2210-738X (electronic) AAPS Advances in the Pharmaceutical Sciences Series ISBN 978-1-4939-2315-1 ISBN 978-1-4939-2316-8 (eBook) DOI 10.1007/978-1-4939-2316-8 Library of Congress Control Number: 2015934451 Springer New York Heidelberg Dordrecht London © Springer Science+Business Media, LLC 2015 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. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
This work is dedicated to the memory of our friend and colleague Ronald Taticek as a tribute to the imagination that led him to undertake a project of this magnitude and made him a pioneer in this field. It is also a tribute to the dedication that i
