Ende Mary Tanya am - Chemical Engineering in the Pharmaceutical Industry, R & d to Manufacturing

1. Chapter 1
2. Chapter 2
3. Chapter 4
4. Chapter 5
5. Chapter 6
6. Chapter 7
7. Chapter 8
8. Chapter 9
9. Chapter 10
10. Chapter 11
11. Chapter 12
12. Chapter 13
13. Chapter 14
14. Chapter 15
15. Chapter 16
16. Chapter 17
17. Chapter 18
18. Chapter 19
19. Chapter 20
20. Chapter 21
21. Chapter 22
22. Chapter 23
23. Chapter 24
24. Chapter 25
25. Chapter 26

1. Chapter 1
2. Chapter 2
3. Chapter 3
4. Chapter 4
5. Chapter 5
6. Chapter 6
7. Chapter 7
8. Chapter 8
9. Chapter 9
10. Chapter 10
11. Chapter 11
12. Chapter 12
13. Chapter 13
14. Chapter 14
15. Chapter 15
16. Chapter 16
17. Chapter 17
18. Chapter 18
19. Chapter 19
20. Chapter 20
21. Chapter 21
22. Chapter 22
23. Chapter 23
24. Chapter 24
25. Chapter 25
26. Chapter 26

Second Edition

Edited by

Mary T. am Ende

Lyndra Therapeutics, Inc., Watertown, MA, USA

David J. am Ende

Nalas Engineering Services, Inc., Centerbrook, CT, USA

This edition first published 2019
2019 John Wiley & Sons, Inc.

A Joint Publication of the American Institute of Chemical Engineers and John Wiley & Sons, Inc.

Edition History
Chemical Engineering in the Pharmaceutical Industry, First edition, John Wiley & Sons, 2011.

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by law. Advice on how to obtain permission to reuse material from this title is available at http://www.wiley.com/go/permissions.

The right of Mary T. am Ende and David J. am Ende to be identified as the authors of the editorial material in this work has been asserted in accordance with law.

Registered Office
John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, USA

Editorial Office
111 River Street, Hoboken, NJ 07030, USA

For details of our global editorial offices, customer services, and more information about Wiley products visit us at www.wiley.com.

Wiley also publishes its books in a variety of electronic formats and by printondemand. Some content that appears in standard print versions of this book may not be available in other formats.

Limit of Liability/Disclaimer of Warranty
In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of experimental reagents, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each chemical, piece of equipment, reagent, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. While the publisher and authors have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

Library of Congress CataloginginPublication Data

Names: Ende, Mary Tanya am, editor. | Ende, David J. am, editor.
Title: Chemical engineering in the pharmaceutical industry : drug product design, development and modeling / edited by Mary Tanya am Ende, Global R&D, Pfizer, Inc., Groton, CT, USA, David J. am Ende, Nalas Engineering Services, Inc., Centerbrook, CT, USA.
Description: Second edition. | Hoboken, NJ, USA : Wiley, 2019. | Includes bibliographical references and index. |
Identifiers: LCCN 2018054741 (print) | LCCN 2018055054 (ebook) | ISBN 9781119285519 (AdobePDF) | ISBN 9781119285502 (ePub) | ISBN 9781119285496 (hardcover)
Subjects: LCSH: Pharmaceutical technology. | Biochemical engineering. | Chemical engineering.
Classification: LCC RS192 (ebook) | LCC RS192 .C525 2019 (print) | DDC 615.1/9dc23
LC record available at https://lccn.loc.gov/2018054741

Cover Design: Wiley
Cover Images: Courtesy of Johannes G. Khinast, ProXES, Inc.,
Pfizer Inc., Courtesy of Xiao Yu Wu

Paige Adack
Senior Scientist
Pharmaceutical Commercialization Technology
Merck & Co., Inc.
West Point, PA, USA

Otute Akiti, PhD
Head of CMC
BlackThorn Therapeutics
San Francisco, CA, USA

Alberto Aliseda, PhD
Assistant Professor
Department of Mechanical Engineering
University of Washington
Seattle, WA, USA

David J. am Ende, PhD
President
Nalas Engineering Services, Inc.
Centerbrook, CT, USA

Mary T. am Ende, PhD
Research Fellow
Process Modeling & Engineering Technology Group
Pfizer, Inc.
Groton, CT, USA
Current address: Lyndra Therapeutics, Watertown, MA, USA

Leah Appel, PhD
Managing Partner
Green Ridge Consulting
Bend, OR, USA

Piero M. Armenante, PhD
Distinguished Professor of Chemical Engineering
Otto H. York Department of Chemical and Materials Engineering
New Jersey Institute of Technology
University Heights
Newark, NJ, USA

Thomas Baxter
Director
Jenike & Johanson, Inc.
Tyngsboro, MA, USA

Alfred Berchielli
Senior Principal Scientist
Drug Product Design
Pfizer, Inc.
Groton, CT, USA

Rahul Bharadwajh, PhD
Vice President, Engineering and Business Development
Engineering Simulation and Scientific Software (ESSS), Rocky DEM, Woburn, MA, USA

Kevin J. Bittorf, PhD, MBA, PEng
Formulation Development
Vertex Pharmaceuticals
Cambridge, MA, USA
Current affiliation: Principal Consultant Simulation LLC
Boston, MA, USA

Daniel O. Blackwood
Research Fellow
Drug Product Design
Pfizer, Inc.
Groton, CT, USA

John Blyth
Senior Scientist
AstraZeneca
Macclesfield, UK

Peter Bhling
Scientist
Research Center Pharmaceutical Engineering GmbH