Challenges in Protein Product Development
In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of
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Nicholas W. Warne Hanns-Christian Mahler Editors
Challenges in Protein Product Development
AAPS Advances in the Pharmaceutical Sciences Series Volume 38
Series Editor Yvonne Perrie, Strathclyde Institute of Pharmacy, University of Strathclyde, Bearsden, Dunbartonshire, UK
The AAPS Advances in the Pharmaceutical Sciences Series, published in partnership with the American Association of Pharmaceutical Scientists, is designed to deliver 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
Nicholas W. Warne Hanns-Christian Mahler •
Editors
Challenges in Protein Product Development
123
Editors Nicholas W. Warne BioTherapeutics Research and Development Pharmaceutics Research and Development Pfizer Inc. Andover, MA USA
Hanns-Christian Mahler Lonza AG Drug Product Services Basel, Basel Stadt Switzerland
ISSN 2210-7371 ISSN 2210-738X (electronic) AAPS Advances in the Pharmaceutical Sciences Series ISBN 978-3-319-90601-0 ISBN 978-3-319-90603-4 (eBook) https://doi.org/10.1007/978-3-319-90603-4 Library of Congress Control Number: 2018939307 © American Association of Pharmaceutical Scientists 2018 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. Printed on acid-free paper This Springer imprint is published by the registered company Springer International Publishing AG part of Springer Nature The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Preface
The use of therapeutic proteins continues to increase, with most of these protein drug products being used to treat severe diseases such as various types of cancer or inflammation. As the field of recombinant therapeutic proteins enters its fou
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