Name of supplement chapter name
Cover: patpitchaya - Stock.adobe.com
PANDEMIC RESPONSE
Bio/Pharma Industry Works
Overtime to Find COVID-19 Therapies
Feliza Mirasol 3
REGULATORY GUIDANCE
GMPs Guide COVID-19 Vaccine Manufacturing
Feliza Mirasol 9
Viral Vector API Characterization
of Product-Related Impurities
Peter Wunderli, Jun Lu, Jie Ding, Mercedes Ames,
Marc Wolman, Jared Finger, and Stephen Gacheru 12
DATA INTEGRITY
Do Pharmacopoeias Inadvertently
Facilitate Data Integrity Violations?
C. Burgess and R.D. McDowall 18
Tackling Cybersecurity
Challenges in Legacy Systems
Robert Brokamp and Adi Karisik 28
PROCESS DEVELOPMENT
Enhancing Process Validation for
Sterile Liquid and Freeze-Dried Forms
Francesca Speroni, Ilaria Franceschini, Maurizio Valleri, Mauro Silvestri,
Matteo De Nigris, Simona Bertolini, Luca Rizzo, Alessia Garavaglia,
Camillo Bologna, Rosa Terribile, Stefano Pompilio, Enrico Modena, Stefano
Selva, Lorenza Broccardo, Cesare Armetti, and Marco Adami 31
Due Diligence Assessment
of CMC Activities
William J. Lambert 42
QUALITY
Viewpoint: Precompetitive Collaboration
Drives Pharma Industry Innovation
Margaret M. Faul, Carl L. McMillian, Pierre Boulas, Reginaldo A. Saraceno,
Mary Devlin Capizzi, and Maureen T. Cruz 45
Strong Quality Culture:
A How-To for Busy Managers
Norm Howe 50
RESOURCES
Resources, Guidelines,
and Guidance Documents
54
Regulatory and Standard
Setting Organizations
56
Ad Index 59
Regulatory Sourcebook
October 2020
Contents
© 2020 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may
be reproduced or transmitted in any form or by any means, electronic or mechanical including by
photocopy, recording, or information storage and retrieval without permission in writing from the publisher.
Authorization to photocopy items for internal/educational or personal use, or the internal/educational or
personal use of specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other users
registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax
978-646-8700 or visit http://www.copyright.com online. For uses beyond those listed above, please direct
your written request to Permission Dept. Alexa Rockenstein, arockenstein@mmhgroup.com. Reprints:
Contact Michael Tracey, mtracey@mjhlifesciences.com.
MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers'
names, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant
products, services, and other opportunities that may be of interest to you. If you do not want MultiMedia
Pharma Sciences LLC to make your contact information available to third parties for marketing purposes,
simply email mmhinfo@mmhgroup.com and a customer service representative will assist you in removing
your name from MultiMedia Pharma Sciences LLC lists.
BioPharm International does not verify any claims or other information appearing in any of the
advertisements contained in the publication, and cannot take responsibility for any losses or other damages
incurred by readers in reliance of such content.
BioPharm International welcomes unsolicited articles, manuscripts, photographs, illustrations, and
other materials but cannot be held responsible for their safekeeping or return.
To subscribe, email mmhinfo@mmhgroup.com
ADVERTISING
Publisher Mike Tracey MTracey@mjhlifesciences.com
National Sales Manager Scott Vail SVail@mjhlifesciences.com
European Sales Manager Linda Hewitt LHewitt@mjhlifesciences.com
European Senior Sales Executive
Stephen Cleland SCleland@mjhlifesciences.com
Senior Vice President, Industry Sciences Michael Tessalone
MTessalone@mjhlifesciences.com
C.A.S.T. Data and List Information
Michael Kushner MKushner@mjhlifesciences.com
AUDIENCE DEVELOPMENT
Audience Development Christine Shappell cshappell@mjhlifesciences.com
MJH LIFE SCIENCES
TM
Chairman and Founder Mike Hennessy, Sr
Vice Chairman Jack Lepping
President and CEO Mike Hennessy, Jr
Chief Financial Officer Neil Glasser, CPA/CFE
Chief Marketing Officer Michael Baer
Executive Vice President, Operations Tom Tolvé
Executive Vice President, Global Medical Affairs and
Corporate Development Joe Petroziello
Senior Vice President, Audience Generation and
Product Fulfillment Joy Puzzo
Senior Vice President, Content Silas Inman
Senior Vice President, I.T. & Enterprise Systems John Moricone
Vice President, Human Resources & Administration Shari Lundenberg
Vice President, Mergers & Acquisitions Chris Hennessy
Executive Creative Director, Creative Services Jeff Brown
EDITORIAL
Editorial Director Rita Peters RPeters@mjhlifesciences.com
Senior Editor Agnes M. Shanley AShanley@mjhlifesciences.com
Managing Editor Susan Haigney SHaigney@mjhlifesciences.com
European Editor Felicity Thomas FThomas@mjhlifesciences.com
Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com
Manufacturing Editor Jennifer Markarian JMarkarian@mjhlifesciences.com
Assistant Editor Lauren Lavelle LLavelle@mjhlifesciences.com
Creative Director, Publishing Melissa Feinen
Senior Art Director Marie Maresco
Graphic Designer Maria Reyes
BioPharm
I N T E R N AT I O N A L
eBook
T h e S ci e n ce & B usi n e ss o f B i o p h a r m a ce u t i c a ls
2 BioPharm International eBook October 2020 www.biopharminternational.com
