BioPharm International, September 2011 - BioPharm International

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BioPharm International, September 2011
Features
Organizational Structures of Process Development and Manufacturing Support
By Konstantin Konstantinov , Steve Sofen
How to strike a balance between site autonomy and global coordination.
Technologies for Downstream Processing
By Margit Holzer
The author describes recent developments to help overcome the downstream-processing bottleneck.
The Future of Downstream Processing
By Uwe Gottschalk, PhD
The author reviews the state of downstream processing, including a look at the streamlining of full processes and borrowed technologies.
From the Editor
Retrospection and Introspection at FDA
By Michelle Hoffman
A report commissioned by FDA evaluates the QbD paradigm.
Regulatory Beat
Manufacturers and FDA Gear Up for User-Fee Action
By Jill Wechsler
PDUFA renewal legislation sets stage for new policies affecting revenue, research, and oversight.
Compliance Notes
Following Our Own Instructions
By Susan J. Schniepp
Why SOPs are rarely followed, often cited, and in great need of follow-through.
Perspectives on Outsourcing
The EU Debt Crisis and CMOs
By Jim Miller
The EU debt crisis portends of possible negative repercussions for the dose CMO industry.
Final Word
Advocating for Biosimilar Approval Standards Under BPCI
By Chad Landmon , Elizabeth S. Retersdorf
FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.

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