June 2012 Issue
Global supply needs are dictating facility locations and CMO selection.
FDAs Rick Friedman and Karthik Iyer explain why some manufacturers need to get a better grip on GMP-related statistics.
Manufacturers are reporting fewer batch failures, adopting PAT and other quality initiatives, and stepping up supply chain quality control.
Business forces, bioterror and pandemic risks demand new approaches to manufacturing.
Regulators have paved the way for low-cost biologics, but its up to manufacturers to select the right technologies and define quality.
The idea that the product is the process and the process is the product can either result in sameness, or true control.
A tribute to our dear friend and colleague, Julie Cappelletti-Lange.
The yin is just as important as the yang; sometimes, even more so.
To survive, Steven Burrill tells Big Pharma, ignore the gravel in the road and embrace the disruption.
Facilities often use complex and time-consuming tools to accomplish what should be a simple task.
Accurate answers to the wrong questions pose risks and unnecessarily drive up costs.