2 BioPharm International eBook July 2021 www.biopharminternational.com
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EDITORIAL
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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
Contents
Biopharmaceutical
Analysis 2021
ANALYTICAL EVOLUTION
Complex Biomolecules
Require Analytical Evolution
Feliza Mirasol 4
METHOD VALIDATION
Best Practices for Analytical Method
Validation: Study Design, Analysis,
and Acceptance Criteria
Thomas A. Little 10
DATA INTEGRITY
Data Integrity Considerations for
Vendor-Generated Data Associated
with Analytical Testing
Thomas Cullen, Cliff Mitchell, Julie Lippke, Joseph Mongillo,
Koottala S. Ramaswamy, and Thomas Purdue
15
IMPURITY ANALYSIS
Detecting Residual HCPs
Demands a Holistic Approach
Olaf Stamm, Andrew Hanneman, Art Cansizoglu,
and Thorsten Strahl
20
Increasing the Depth and Reliability
of HCP Analysis Using TIMS-MS
Stuart Pengelley 26
PROTEIN CHARACTERIZATION
Improving IR Spectroscopy as
a Tool for Biopharmaceutical Analysis
Holly Lombardo and Matthew McGann 31
CLEANING VALIDATION
Prioritizing Cleaning Validation
Agnes Shanley 35
Ad Index 37
Cover: mnimpres - Stock.adobe.com
