2 BioPharm International eBook May 2021 www.biopharminternational.com
Cover: md3d - Stock.adobe.com
MANUFACTURING
CDMO Landscape Seeing Changes
as Consolidation Continues
Feliza Mirasol 4
RNA's Expanding Horizons
Felicity Thomas 8
ANALYTICS
Challenges When
Outsourcing Viral Safety Services
Laurent Lafferrère and Audrey Brussele 12
QUALITY/REGULATIONS
Ensuring Contract Manufacturing
Facilites are Up to Speed
Susan Haigney 18
Succeeding with Remote Audits
Mike Kawan 24
OPERATIONS
Demystifying Complex
Clinical Trial Kit Preparation
Natalie Balanvosky and Bryan Thompson 28
CDMO Partnerships Boost
Company Capabilities
Lauren Lavelle 34
Ad Index 38
Partnerships for
Outsourcing 2021
Contents
© 2021 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, Global Medical Affairs and
Corporate Development Joe Petroziello
Senior Vice President, Content Silas Inman
Senior Vice President, Operations Michael Ball
Senior Vice President, I.T. & Enterprise Systems Scott Stopper
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
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
Senior 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
