Introduction to Biologic and Biosimilar Product Development and Analysis
The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery.
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Karen M. Nagel
Introduction to Biologic and Biosimilar Product Development and Analysis
AAPS Introductions in the Pharmaceutical Sciences Editor-in-Chief: Robin M. Zavod Midwestern University, Downers Grove, IL, USA
Springer and the American Association of Pharmaceutical Scientists (AAPS) have partnered again to produce a second series that juxtaposes the AAPS Advances in the Pharmaceutical Sciences series. It is a set of introductory volumes that lay out the foundations of the different established pockets and emerging subfields of the pharmaceutical sciences. Springer and the AAPS aim to publish scholarly science focused on general topics in the pharma and biotech industries, and should be of interest to students, scientists, and industry professionals. More information about this series at http://www.springer.com/series/15769
Karen M. Nagel
Introduction to Biologic and Biosimilar Product Development and Analysis
Karen M. Nagel Chicago College of Pharmacy Midwestern University Downers Grove, IL, USA
AAPS American Association of Pharmaceutical Scientists holds the copyright ISSN 2522-834X ISSN 2522-8358 (electronic) AAPS Introductions in the Pharmaceutical Sciences ISBN 978-3-319-98427-8 ISBN 978-3-319-98428-5 (eBook) https://doi.org/10.1007/978-3-319-98428-5 Library of Congress Control Number: 2018954052 © 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. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Preface
This book is targeted at those in the pharmaceutical industry who have worked only with small molecule products, in order to give them a brief introduction to the differences in processing, analysis, and delivery of peptides, proteins, monoclonal antibodies, a
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