BioPharm International-09-01-2011

Structures and Manufacturing Support

Regulatory Beat

September 01, 2011

PDUFA renewal legislation sets stage for new policies affecting revenue, research, and oversight.

Features

September 01, 2011

The author reviews the state of downstream processing, including a look at the streamlining of full processes and borrowed technologies.

Compliance Notes

September 01, 2011

Why SOPs are rarely followed, often cited, and in great need of follow-through.

Features

September 01, 2011

The author describes recent developments to help overcome the downstream-processing bottleneck.

How to strike a balance between site autonomy and global coordination.

From the Editor

September 01, 2011

A report commissioned by FDA evaluates the QbD paradigm.

Perspectives on Outsourcing

September 01, 2011

The EU debt crisis portends of possible negative repercussions for the dose CMO industry.

FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.