P h a r mTe c h . c o m
ASEPTIC PROCESSING VIEWPOINT
4 Lies That Environmental
Monitoring
Systems Tell
James Agalloco, Russell Madsen, and James Akers
DEVELOPING TECHNOLOGIES
8
Albumin Attachment
Can Make
Better Biobetters
Feliza Mirasol
PROCESS MODELING
14 Characterizing a Bioprocess
with Advanced Data Analytics
Lennart Eriksson and Chris McCready
BIOREACTOR DESIGN
20 Impact of Agitator Design
on Bioreactor Performance
Aaron Strand and Nicolle Courtemanche
OPTIMIZING LYOPHILIZATION
26 Can Standards Help Pharma
Modernize Lyophilization?
Agnes Shanley
LYOPHILIZATION
30 Residual Moisture Testing
Methods for Lyophilized Drug Products
Amy M. Bosch and Edward H. Trappler
TECH TRANSFER
40 Aseptic Transfer Technology:
Weighing Up the Advantages of Varying
Approaches for Sterile Drug Manufacturing
Christian Dunne
FILL/FINISH
44 Ready-to-Use Parenteral Packaging
Components Address Evolving
Aseptic Fill/Finish Requirements
Simon Cote
48 New Technologies Streamline
Fill/Finish Manufacturing
Amber Lowry
QUALITY
50 Understanding Validation
and Technical Transfer
Russell E. Madsen
62 Ad Index
Cover Images: Static CoverÐitsmejust/Shutterstock.com; Animated CoverÐDmitry Kalinovsky/Jarun Ontakrai/
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Biologics and Sterile Drug Manufacturing 2018
EDITORIAL
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and Cynthia A. Challener, PhD challener@vtlink.net
Correspondent Sean Milmo (Europe, smilmo@btconnect.com)
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Executive Vice-President, Senior Managing Director,
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VP/Managing Director, Pharm/Science Group,
UBM Life Sciences
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