BioPharm
I N T E R N AT I O N A L
eBook
Contents
T h e S ci e n ce & B u si n e ss o f B i o p h a r m a ce u t i c a ls
Static Cover – stock.adobe.com: tilialucida
Animated Cover – stock.adobe.com: sinhyu, tilialucida, djama,
Alexandr Mitiuc, ӣӣ (Gilwoo Shin), angellodeco.
RAW MATERIALS TESTING
Analytical Best Practices
for Raw Materials Testing
Feliza Mirasol
The testing of raw materials is essential as raw
material quality determines the outcome of biologic
product quality. 4
BIOSIMILAR ANALYSIS
An Analytical Approach to
Biosimilar Drug Development
Feliza Mirasol
Providing analytical data on the comparison between a
biosimilar and the reference product is a primary
consideration in the development of biosimilars. 8
GLYCAN ANALYSIS
Glycan Analysis Best Practices
Susan Haigney
Experts discuss best practices for performing
glycan analysis. 12
PROTEIN CHARACTERIZATION
Complex Protein Studies
Demand Dynamic Techniques
Rita Peters
By adapting techniques from other sciences—
and exploring better tools for biologics drug
development—researchers are addressing challenges
of protein characterization. 18
ANALYTICAL METHODS
Best Practices in Analytical
Method Development and Testing
Mario DiPaola
This article discusses why it is important to apply
risk analysis, QbD, and DoE in the development of
analytical methods. 22
OUTSOURCING
Barriers and Solutions to Effective
External Collaboration in Biopharma
Paul Denny-Gouldson
As biopharma companies rapidly change their focus,
they may lack the laboratory space, instrumentation, and
the scientific knowledge to support biologics research. 26
Ad Index 28
Biopharma Laboratory
Best Practices 2018
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
European Editor Felicity Thomas felicity.thomas@ubm.com
Science Editor Feliza Mirasol feliza.mirasol@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
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PRODUCTION
Production Manager Jesse Singer jsinger@hcl.com
AUDIENCE DEVELOPMENT
Audience Development Christine Shappell christine.shappell@ubm.com
Thomas W. Ehardt
Executive Vice-President, Senior Managing Director,
UBM Life Sciences Group
Dave Esola
VP/Managing Director, Pharm/Science Group
UBM Life Sciences
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www.biopharminternational.com October 2018 BioPharm International eBook 3
