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.”

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Every so often we like to browse through pharma industry LinkedIn groups to see what’s being said about QbD, PAT, and other Quality-related topics. What follows is a summary of some recent intriguing threads. (Note: Many of these groups require membership–simply ping the group manager to join.)

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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”?

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By Agnes Shanley, Editor in Chief

PharmaQbD: Has drug manufacturing advanced in the last decade?

A.H.: I’ve probably kept up more on the regulatory side and what’s happening with different companies. The progress seems to be slow when one looks at news reports on shortages, recalls and other quality issues. Prevention of such issues was, in part, the motivation for FDA to launch the PAT and then the CGMP for the 21^st Century Initiative.

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By Erica Brooks and Yasmeen Muhammad, Compliance Implementation Services

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Is Quality by Design too great a burden on small manufacturers? We recently posted on this topic, and also posed the question on the Quality-by-Design LinkedIn group. Since then, the torrent of comments (sign in and request to join if you’re not a member) has been encouraging, amusing, and enlightening. As of today, 82 comments and counting.

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