Contents
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
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Outsourcing Resources
2018
DRUG DEVELOPMENT
Outsourcing: Does Focus Pay Off?
Agnes Shanley 4
COMPLETE RESPONSE LETTERS
Avoiding Complete Response Letters
Agnes Shanley 7
QUALITY
Quality Oversight During
Sterile Filling Operations
Philip Hoersch 11
QUALITY AGREEMENTS
Good Quality Agreements
Support Compliance with CGMP
Paula Katz, Tamara Ely, Linda Joy, and Jessica Ritsick 16
PROCESS VALIDATION
Process Validation in
Biologics Development
Susan Haigney 22
CONTRACT BIOMANUFACTURING
Bigger is Better in Samsung's
Approach to Biomanufacturing
Rita Peters 24
ANALYTICS OUTSOURCING
Choosing an Analytical Partner
in Early Drug Development
Feliza Mirasol 27
ANALYZING BIOLOGICS
Gaining Analytical Insight
in the Development of Biologics
Susan Haigney 30
MARKET INVESTMENT
Contract Services Investment Update
Amber Lowry 33
Ad Index 35
Static Cover – Sukjai Photo
Animated Cover – Shutterstock.com: Sukjai Photo, Hanna Kuprevich,
Traimak, Docstockmedia, Kunst Bilder, Itsmejust,
Angellodeco, Dextroza, Gajus.
EDITORIAL
Editorial Director Rita Peters rita.peters@ubm.com
Senior Editor Agnes M. Shanley agnes.m.shanley@ubm.com
Managing Editor Susan Haigney susan.haigney@ubm.com
Science Editor Feliza Mirasol feliza.mirasol@ubm.com
Science Editor Adeline Siew, PhD adeline.siew@ubm.com
Manufacturing Editor Jennifer Markarian jennifer.markarian@ubm.com
Associate Editor Amber Lowry amber.lowry@ubm.com
Art Director Dan Ward dward@hcl.com
Contributing Editors Jill Wechsler, Jim Miller, Eric Langer,
Anurag Rathore, and Cynthia A. Challener, PhD
Correspondent Sean Milmo (Europe, smilmo@btconnect.com)
ADVERTISING
Publisher Mike Tracey mike.tracey@ubm.com
National Sales Manager Scott Vail scott.vail@ubm.com
European Sales Manager Linda Hewitt linda.hewitt@ubm.com
European Senior Sales Executive
Stephen Cleland stephen.cleland@ubm.com
C.A.S.T. Data and List Information
Michael Kushner michael.kushner@ubm.com
Reprints 877-652-5295 ext. 121/ bkolb@wrightsmedia.com
Outside US, UK, direct dial: 281-419-5725. Ext. 121
PRODUCTION
Production Manager Jesse Singer jsinger@hcl.com
AUDIENCE DEVELOPMENT
Audience Development
Christine Shappell christine.shappell@ubm.com
UBM LIFE SCIENCES
Thomas W. Ehardt, Executive Vice-President, Senior Managing
Director, UBM Life Sciences Group
Dave Esola, VP/Managing Director, Pharm/Science Group,
UBM Life Sciences
www.biopharminternational.com March 2018 BioPharm International eBook 3