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Gunter Jagschies - Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes

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Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes: summary, description and annotation

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Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry.

The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry.

  • Offers a comprehensive, go-to reference for daily work decisions
  • Covers both upstream and downstream processes
  • Includes case studies that emphasize financial outcomes
  • Presents summaries, decision grids, graphs and overviews for quick reference

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Biopharmaceutical Processing Development Design and Implementation of - photo 1
Biopharmaceutical Processing
Development, Design, and Implementation of Manufacturing Processes

First Edition

Gnter Jagschies

Eva Lindskog

Karol cki

Parrish Galliher

Copyright Elsevier Radarweg 29 PO Box 211 1000 AE Amsterdam Netherlands The - photo 2

Copyright

Elsevier

Radarweg 29, PO Box 211, 1000 AE Amsterdam, Netherlands

The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, United Kingdom

50 Hampshire Street, 5th Floor, Cambridge, MA 02139, United States

2018 Elsevier Ltd. All rights reserved.

No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publishers permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions.

This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein).

Notices

Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.

Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.

To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.

Library of Congress Cataloging-in-Publication Data

A catalog record for this book is available from the Library of Congress

British Library Cataloguing-in-Publication Data

A catalogue record for this book is available from the British Library

ISBN: 978-0-08-100623-8

For information on all Elsevier publications visit our website at https://www.elsevier.com/books-and-journals

Publisher John Fedor Acquisition Editor Kostas KI Marinakis Editorial - photo 3

Publisher: John Fedor

Acquisition Editor: Kostas KI Marinakis

Editorial Project Manager: Michelle Fisher

Production Project Manager: Maria Bernard

Cover Designer: Victoria Pearson

Typeset by SPi Global, India

Contributors

Numbers in parentheses indicate the pages on which the authors contributions begin.

(165), Biogen Inc., Cambridge; Visterra Inc., Cambridge, MA, United States

Visterra Inc., Cambridge, MA, United States

(1151), BristolMyers Squibb, New Brunswick, NJ, United States

(1001), Shire, Lexington, MA

Celgene, Summit, NJ, United States

(513), GE Healthcare Life Sciences, Uppsala, Sweden

(579), Zenith Technologies, Dublin, Ireland

(409), GE Healthcare Life Sciences, Uppsala, Sweden

(857), Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria

(513), GE Healthcare Life Sciences, Uppsala, Sweden

Maire H. Caparon (769), Pfizer Inc., Chesterfield, MO, United States

(513), GE Healthcare Life Sciences, Uppsala, Sweden

(1159), GE Healthcare Life Sciences, Marlborough, MA, United States

(131,457), GE Healthcare Life Sciences, Uppsala, Sweden

(769), Pfizer Inc., Chesterfield, MO, United States

(457), GE Healthcare Life Sciences, Marlborough, MA, United States

(769), Pfizer Inc., Chesterfield, MO, United States

(769), Pfizer Inc., Chesterfield, MO, United States

(857), John Curling Consulting AB, Uppsala, Sweden

(367), GE Healthcare Life Sciences, Uppsala, Sweden

(401,433,637), Gozo Biotech Consulting, Gozo, Malta

(147), Biotechnology Consultant, Logan, UT, United States

(899), University College London, London, United Kingdom

(111,131), Boehringer Ingelheim, Biberach, Germany

(269), GE Healthcare Life Sciences, Uppsala, Sweden

(557), Xcellerex, Inc., A GE Healthcare Life Sciences Company, Marlborough, MA, United States

(493), GE Healthcare Life Sciences, Uppsala, Sweden

(837), Purification Development, Pharma Technical Development, Genentech (Roche), South San Francisco, CA, United States

(701), Biogen Inc. Cambridge, MA, United States

(379,675), GE Healthcare Life Sciences, Uppsala, Sweden

(1075), PathoGuard Consult, Seeheim-Jugenheim, Germany

(701), Biogen Inc. Cambridge, MA, United States

(421), GE Healthcare Life Sciences, Uppsala, Sweden

(1105), Hejnaes Consult AB, Simlaangsdalen, Sweden

(813), Genentech Inc., South San Francisco, CA, United States

(269,675), CERVUS Biotech Consulting, Uppsala, Sweden

(987), Unum Therapeutics, Cambridge, MA, United States

(813), Genentech Inc., South San Francisco, CA, United States

(3,33,59,73,207,221,241,477,513,527,1191, 1227,1233,1237), GE Healthcare Life Sciences, Freiburg im Breisgau, Germany

Michael J. Jenkins (899), University College London, London, United Kingdom

(477), GE Healthcare Life Sciences, Uppsala, Sweden

(637,933), GE Healthcare Lifesciences, Amersham

GE Healthcare, Little Chalfond, United Kingdom

(741), Amgen, Thousand Oaks, CA, United States

Gautam Kapoor (1051), Indian Institute of Technology, New Delhi, India

(513), GE Healthcare Life Sciences, Uppsala, Sweden

(1137), Genentech, South San Francisco, CA, United States

(1137), Roche, Penzberg, Germany

Jashwant Kumar (1051), Indian Institute of Technology, New Delhi, India

(73,207,221,241,319,637), VP Technology Development, Avitide, Inc., United States

Karol Lacki Consulting AB, Hllviken, Sweden

(1137), Genentech, South San Francisco, CA, United States

(279,295,441), GE Healthcare Life Sciences, Uppsala, Sweden

(813), Genentech Inc., South San Francisco, CA, United States

(97,111,457,625), Lonza Pharma & Biotech, Basel, Switzerland

(147,877), GE Healthcare, Life Sciences, Uppsala, Sweden

(769), Pfizer Inc., Chesterfield, MO, United States

(579), Zenith Technologies, Dublin, Ireland

(769), Pfizer Inc., Chesterfield, MO, United States

(793), Bioprocess Sciences and Technology, Amgen, Cambridge, MA, United States

(1171), GE Healthcare, Chicago, IL, United States

(1159), GE Healthcare Life Sciences, Marlborough, MA, United States

(513), GE Healthcare Life Sciences, Uppsala, Sweden

(813), Genentech Inc., South San Francisco, CA, United States

(477), Martin stling Konsult AB, Uppsala, Sweden

(165), Biogen Inc., Cambridge

Visterra Inc., Cambridge, MA, United States

(721), Merck & Co., Inc., Kenilworth, NJ, United States

(721), Pharma-Consulting ENABLE GmbH, Solothurn, Switzerland

(877), Moderna Therapeutics, Cambridge, MA, United States

(769), Pfizer Inc., Chesterfield, MO, United States

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