At the recent Interphex 2012 show in New York City, Agnes Shanley caught up with Chris Amstutz, Director of Life Science Industry Consulting at Emerson Process Management. In the video below, Amstutz provides a brief look at the recent progression of PAT and QbD in the drug industry.

 Read more...

By Mark J. Anderson, Principal, Stat-Ease, Inc.

Given the push for Quality by Design by FDA and agencies worldwide, statistical methods are becoming increasingly vital for pharmaceutical manufacturers. Design of Experiments (DOE) is a primary tool because “it provides a structured, organized method for determining the relationship between factors affecting a process and the response of that process” [1].

 Read more...

By Emil W. Ciurczak, Contributing Editor

I have been following a number of conversations on LinkedIn that are driving me to imbibe large amounts of adult beverages. The number of people who disagree on what various terms mean is astounding. For example, we all think we know what PAT means, no? Apparently, no.

 Read more...

By Paul Thomas, Senior Editor

In introducing biotech guru G. Steven Burrill today, Illinois BIO (iBIO) president David Miller likened the speaker to the Michael Jordan of biotechnology. “There will never be the next Steven Burrill,” he said. “At a critical time in biotech’s development, he was there.”

 Read more...

By Paul Thomas, Senior Editor

 Read more...

In Pharmaceutical Manufacturing’s April issue cover story, Agnes Shanley takes “The Pulse of Pharmaceutical Manufacturing.” The past decade has seen dramatic shifts in the way we talk and think about drug manufacturing, but, she asks, have practices really changed in the time since FDA’s PAT team was formed and then-Commissioner McClellan wondered why pharma manufacturing was “behind that of potato chip and soap making”?

 Read more...