A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

547 Pages·2017·17.667 MB·English

by  Nuala Calnan, Martin J Lipa, Paige E. Kane, Jose C. Menezes

A Lifecycle Approach
to Knowledge Excellence in
the Biopharmaceutical Industry
BIOTECHNOLOGY AND BIOPROCESSING SERIES
Series Editor
Anurag Rathore
1. Membrane Separations in Biotechnology, edited by W. Courtney McGregor
2. Commercial Production of Monoclonal Antibodies: A Guide for Scale-Up,
edited by Sally S. Seaver
3. Handbook on Anaerobic Fermentations, edited by Larry E. Erickson and
Daniel Yee-Chak Fung
4. Fermentation Process Development of Industrial Organisms, edited by
Justin O. Neway
5. Yeast: Biotechnology and Biocatalysis, edited by Hubert Verachtert and
René De Mot
6. Sensors in Bioprocess Control, edited by John V. Twork and
Alexander M. Yacynych
7. Fundamentals of Protein Biotechnology, edited by Stanley Stein
8. Yeast Strain Selection, edited by Chandra J. Panchal
9. Separation Processes in Biotechnology, edited by Juan A. Asenjo
10. Large-Scale Mammalian Cell Culture Technology, edited by
Anthony S. Lubiniecki
11. Extractive Bioconversions, edited by Bo Mattiasson and Olle Holst
12. Purification and Analysis of Recombinant Proteins, edited by Ramnath
Seetharam and Satish K. Sharma
13. Drug Biotechnology Regulation: Scientific Basis and Practices, edited by
Yuan-yuan H. Chiu and John L. Gueriguian
14. Protein Immobilization: Fundamentals and Applications, edited by
Richard F. Taylor
15. Biosensor Principles and Applications, edited by Löíefc J. Blum and
Pierre R. Coulet
16. Industrial Application of Immobilized Biocatalysts, edited by Atsuo Tanaka,
Tetsuya Tosa, and Takeshi Kobayashi
17. Insect Cell Culture Engineering, edited by Mattheus F. A. Goosen,
Andrew J. Daugulis, and Peter Faulkner
18. Protein Purification Process Engineering, edited by Roger G. Harrison
19. Recombinant Microbes for Industrial and Agricultural Applications,
edited by Yoshikatsu Murooka and Tadayuki Imanaka
20. Cell Adhesion: Fundamentals and Biotechnological Applications,
edited by Martin A. Hjortso and Joseph W. Roos
21. Bioreactor System Design, edited by Juan A. Asenjo and José C. Merchuk
22. Gene Expression in Recombinant Microorganisms, edited by Alan Smith
23. Interfacial Phenomena and Bioproducts, edited by John L. Brash and
Peter W. Wojciechowski
24. Metabolic Engineering, edited by Sang Yup Lee and Eleftherios T. Papoutsakis
BIOTECHNOLOGY AND BIOPROCESSING SERIES 25. Biopharmaceutical Process Validation, edited by Gail Sofer and
Dane W. Zabriskie
26. Membrane Separations in Biotechnology: Second Edition, Revised and
Expanded, edited by William K. Wang
Series Editor
27. Isolation and Purification of Proteins, edited by Rajni Hatti-Kaul
Anurag Rathore and Bo Mattiasson
28. Biotransformation and Bioprocesses, Mukesh Doble, Anil Kumar Kruthiventi,
and Vilas Gajanan Gaikar
1. Membrane Separations in Biotechnology, edited by W. Courtney McGregor 29. Process Validation in Manufacturing of Biopharmaceuticals: Guidelines,
2. Commercial Production of Monoclonal Antibodies: A Guide for Scale-Up, Current Practices, and Industrial Case Studies, edited by Anurag Singh
edited by Sally S. Seaver Rathore and Gail Sofer
3. Handbook on Anaerobic Fermentations, edited by Larry E. Erickson and 30. Cell Culture Technology for Pharmaceutical and Cell-Based Therapies,
Daniel Yee-Chak Fung edited by Sadettin S. Ozturk and Wei-Shou Hu
4. Fermentation Process Development of Industrial Organisms, edited by 31. Process Scale Bioseparations for the Biopharmaceutical Industry,
Justin O. Neway edited by Abhinav A. Shukla, Mark R. Etzel, and Shishir Gadam
5. Yeast: Biotechnology and Biocatalysis, edited by Hubert Verachtert and 32. Processs Synthesis for Fuel Ethanol Production, C. A. Cardona, Ó. J. Sánchez,
René De Mot and L. F. Gutiérrez
6. Sensors in Bioprocess Control, edited by John V. Twork and 33. PAT Applied in Biopharmaceutical Process Development And Manufacturing:
Alexander M. Yacynych An Enabling Tool for Quality-by-Design, edited by Cenk Undey, Duncan Low,
7. Fundamentals of Protein Biotechnology, edited by Stanley Stein Jose C. Menezes, and Mel Koch
8. Yeast Strain Selection, edited by Chandra J. Panchal 34. Stem Cells and Revascularization Therapies, edited by Hyunjoon Kong,
Andrew J. Putnam, and Lawrence B. Schook
9. Separation Processes in Biotechnology, edited by Juan A. Asenjo
35. Process Validation in Manufacturing of Biopharmaceuticals, Third Edition,
10. Large-Scale Mammalian Cell Culture Technology, edited by
edited by Anurag Rathore and Gail Sofer
Anthony S. Lubiniecki
36. A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical
11. Extractive Bioconversions, edited by Bo Mattiasson and Olle Holst
Industry, edited by Nuala Calnan, Martin J. Lipa, Paige E. Kane, and
12. Purification and Analysis of Recombinant Proteins, edited by Ramnath
Jose C. Menezes
Seetharam and Satish K. Sharma
13. Drug Biotechnology Regulation: Scientific Basis and Practices, edited by
Yuan-yuan H. Chiu and John L. Gueriguian
14. Protein Immobilization: Fundamentals and Applications, edited by
Richard F. Taylor
15. Biosensor Principles and Applications, edited by Löíefc J. Blum and
Pierre R. Coulet
16. Industrial Application of Immobilized Biocatalysts, edited by Atsuo Tanaka,
Tetsuya Tosa, and Takeshi Kobayashi
17. Insect Cell Culture Engineering, edited by Mattheus F. A. Goosen,
Andrew J. Daugulis, and Peter Faulkner
18. Protein Purification Process Engineering, edited by Roger G. Harrison
19. Recombinant Microbes for Industrial and Agricultural Applications,
edited by Yoshikatsu Murooka and Tadayuki Imanaka
20. Cell Adhesion: Fundamentals and Biotechnological Applications,
edited by Martin A. Hjortso and Joseph W. Roos
21. Bioreactor System Design, edited by Juan A. Asenjo and José C. Merchuk
22. Gene Expression in Recombinant Microorganisms, edited by Alan Smith
23. Interfacial Phenomena and Bioproducts, edited by John L. Brash and
Peter W. Wojciechowski
24. Metabolic Engineering, edited by Sang Yup Lee and Eleftherios T. Papoutsakis

A Lifecycle Approach
to Knowledge Excellence in
the Biopharmaceutical
Industry

Edited by
Nuala Calnan
Martin J. Lipa
Paige E. Kane
Jose C. Menezes
CRC Press
Taylor & Francis Group
6000 Broken Sound Parkway NW, Suite 300
Boca Raton, FL 33487-2742
© 2018 by Taylor & Francis Group, LLC
CRC Press is an imprint of Taylor & Francis Group, an Informa business
No claim to original U.S. Government works
Printed on acid-free paper
International Standard Book Number-13: 978-1-4987-5047-9 (Hardback)
This book contains information obtained from authentic and highly regarded sources. Reasonable efforts
have been made to publish reliable data and information, but the author and publisher cannot assume
responsibility for the validity of all materials or the consequences of their use. The authors and publishers
have attempted to trace the copyright holders of all material reproduced in this publication and apologize to
copyright holders if permission to publish in this form has not been obtained. If any copyright material has
not been acknowledged please write and let us know so we may rectify in any future reprint.
Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmit-
ted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented,
including photocopying, microfilming, and recording, or in any information storage or retrieval system,
without written permission from the publishers.
For permission to photocopy or use material electronically from this work, please access www.copyright.
com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood
Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and
registration for a variety of users. For organizations that have been granted a photocopy license by the CCC,
a separate system of payment has been arranged.
Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used
only for identification and explanation without intent to infringe.
Visit the Taylor & Francis Web site at
http://www.taylorandfrancis.com
and the CRC Press Web site at
http://www.crcpress.com
Contents
Editors ......................................................................................................................xi
Contributors ...........................................................................................................xv
Introduction .........................................................................................................xix
Section I Making the Case for Knowledge
Excellence in the Biopharmaceutical Industry
1 Why Knowledge Management Is Good Business ...................................3
P.K. Yegneswaran, Michael P. Thien, and Martin J. Lipa
2 Theory of Knowledge Management .........................................................19
Stefanie N. Lindstaedt, Paul Czech, and Angela Fessl
3 Knowledge Management—A Japanese Perspective ..............................41
Yukio Hiyama
4 Accelerating the Opportunity for the Pharmaceutical Industry
through KM ...................................................................................................47
Lauren Trees and Cindy Hubert
Section II Perspectives on Knowledge
5 Who Moved My Facts?: Patient Autonomy and the Evolution
of Infrastructure Mean Best Available Knowledge Is Not
Where It Used to Be ......................................................................................63
Dave deBronkart
6 Valuing Knowledge at Swissmedic— A Regulatory Agency’s
Perspective .....................................................................................................77
Michael Renaudin and Hansjürg Leuenberger
7 Generating New Knowledge from Data: Protecting the Patient
by Exploring What Is “Known” about Quality Defects and
Product Recalls ..............................................................................................97
Nuala Calnan and Anne Greene
vii
viii Contents
8 A Perspective from NASA: Knowledge Services and
Accelerated Learning in NASA—The REAL Knowledge
Approach...............................................................................................117
Ed Hoffman and Jon Boyle
9 An Academic Perspective: Knowledge Management: The
Orphan Enabler—Enabling ICH Q10 Implementation ......................133
Nuala Calnan, Anne Greene, and Paige E. Kane
10 An Academic Perspective: Effective Knowledge Assessment ..........153
Mohamed A. F. Ragab and Amr Arisha
11 Knowledge Management and the Evolving Regulatory Process .....165
Bill Paulson and Paige E. Kane
Section III Practices, Pillars and Enablers:
Foundations for Successful KM
12 The House of Knowledge Excellence— A Framework for Success .....181
Paige E. Kane and Martin J. Lipa
13 A Holistic Approach to Knowledge Management: Pfizer
Global Supply ..............................................................................................225
Paige E. Kane and Alton Johnson
14 KM Evolution at Merck & Co., Inc.: Managing Knowledge in
Merck Manufacturing Division ..............................................................243
Martin J. Lipa and Jodi Schuttig
15 Integrating Knowledge Management with Quality
Management Systems to Manufacture Pharmaceuticals
Consistently and Reliably .........................................................................261
Barbara Allen
16 Working with the IS/IT Function to Setup Your Knowledge
Management Project for Success .............................................................271
Joseph Horvath
17 Knowledge Management Implementation: A Guide to Driving
Successful Technology Realization ........................................................281
Doug Redden, DBA
Contents ix
Section IV Practices and Case Studies in
Enabling Knowledge Flow
18 Let’s Talk about Knowledge Management—Learning from the
Library of Alexandria Disaster ................................................................297
Matthew Neal and Sandra Bush
19 Rapid and Robust Product Development Powered by
Knowledge Management Capability ......................................................313
Anando Chowdhury
20 Knowledge Management Case Study: Using Near Real-Time
Data Analytics and Performance Metrics to Ensure a Robust
and Resilient Supply Chain .....................................................................329
Eda Ross Montgomery, Mani Sundararajan, David Lowndes, and
Gabriele Ricci
21 Knowledge Management Elements in Support of Generation
of Chemistry, Manufacturing, and Controls Regulatory
Documentation ............................................................................................341
Beth Junker
22 A People Approach to Managing Knowledge: Why Do You
Come to Work and Who Are You Working For? ..................................361
Siân Slade and Catherine Shen
23 Developing a Lessons Learned Process—Where Lessons Are
Learned: A Case Study of Pfizer Pharmaceutical Sciences ................381
Phil Levett
24 Capturing Critical Process and Product Knowledge:
The Development of a Product History File .........................................395
David Reifsnyder, Kate Waters, and Kayhan Guceli
25 Communities of Practice: A Story about the VTN and the
Value of Community ..................................................................................407
Renee Vogt, Joseph Schaller, and Ronan Murphy
26 Identification of Critical Knowledge: Demystifying
Knowledge Mapping .................................................................................421
Paige E. Kane with a special contribution from Christopher Smalley