BioPharm International, September 2011 Issue (PDF)
Structures and Manufacturing Support
Manufacturers and FDA Gear Up for User-Fee Action
PDUFA renewal legislation sets stage for new policies affecting revenue, research, and oversight.
The Future of Downstream Processing
The author reviews the state of downstream processing, including a look at the streamlining of full processes and borrowed technologies.
Following Our Own Instructions
Why SOPs are rarely followed, often cited, and in great need of follow-through.
Technologies for Downstream Processing
The author describes recent developments to help overcome the downstream-processing bottleneck.
Organizational Structures of Process Development and Manufacturing Support
How to strike a balance between site autonomy and global coordination.
Retrospection and Introspection at FDA
A report commissioned by FDA evaluates the QbD paradigm.
The EU Debt Crisis and CMOs
The EU debt crisis portends of possible negative repercussions for the dose CMO industry.
Advocating for Biosimilar Approval Standards Under BPCI
FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.
