February 2005 Issue
FDA wants its drug investigators to go to a higher level. Can they get there? Will they really make a difference?
Legitimate concerns over patent protection, profits and shareholder value are being balanced by ethics and humanism
Brand name drug manufacturers are using novel formulations and delivery methods and creative life-cycle strategies to thwart an emboldened generics industry.
What's good for upstream processes -- higher concentration levels for MAbs and proteins -- can strain downstream operations, forcing manufacturers to rethink the purification train.
Biosimulation, if done right, aids in allocating equipment, managing utility requirements and optimizing processes. Here's how to apply simulation to improve purification.