Archive | Readers’ Choice

Transdermal Drug Development Using Quality-by-Design

Transdermal Drug Development Using Quality-by-Design

    By Bir (Barry) Gujral and Peter Amanatides, Noven Pharmaceuticals

    Posted in Expert Insights, Readers' Choice, Resources0 Comments

    Baxter: Modeling for Real-Time Release of Device Components

    Baxter: Modeling for Real-Time Release of Device Components

      By Paul Thomas, Senior Editor

      At the 2012 Umetrics Users Meeting today in Chicago, Lee Hutson, Senior Principal Engineer for Baxter Healthcare in Mountain Home, Arkansas, presented on “Achieving Real-time Release of Medical Device Components.” In particular, Hutson elaborated on Baxter’s work in improving processes for the manufacture of injection-molded components.

      Posted in Expert Insights, Readers' Choice0 Comments

      Steven Burrill: Can Pharma Turn the Oceanliner Around?

      Steven Burrill: Can Pharma Turn the Oceanliner Around?

        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.”

        Posted in Expert Insights, Readers' Choice2 Comments

        LinkedIn LookIn: Advice, Jabs, Jobs, and More

        LinkedIn LookIn: Advice, Jabs, Jobs, and More

          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.)

          Posted in QbD News, Readers' Choice0 Comments

          Drug Manufacturing: Still Waiting for the Sea Change?

          Drug Manufacturing: Still Waiting for the Sea Change?

            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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            Ajaz Hussain on the State of Pharmaceutical Manufacturing

            Ajaz Hussain on the State of Pharmaceutical Manufacturing

              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 21st Century Initiative.

              Posted in Expert Insights, Readers' Choice0 Comments

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