For pharmaceutical and biopharmaceutical manufacturers, there are a lot confusion around the concepts of design space (DS), Process Analytical Technology (PAT), and Quality by Design (QbD). Emerson's Zuwei Jin believes that this confusion has largely limited the...
Many manufacturers in the Life Sciences industry are challenged to respond to a new paradigm for process development and manufacturing. The FDA's cGMP for the 21st Century initiative is driving the industry to change its development and manufacturing to be based on...
We're now just a couple of weeks away from the September 30-October 4 Emerson Exchange conference in the Dallas/Fort Worth area of Texas. Today's the last day to save $200 on the conference fee, so register today if you're planning on joining us. If you're in the...
In an earlier post, Trends in Process Analytical Technology and Quality by Design, I highlight a point made in the video, "…PAT methods around product moisture, which projected a $2 million annual savings in improved product quality." The methodology used for the...
At the recent conference for pharmaceutical and biotech manufacturers, Interphex 2012, Pharmaceutical Manufacturing magazine Editor in Chief Agnes Shanley discussed trends in the industry's use of process analytical technology (PAT) and quality by design (QbD) with...
On Pharmaceutical Manufacturing magazine's web site, PharmaManufacturing.com is an 8-minute video presentation given by Emerson's Melissa Herkt. She gave the presentation, Excellence by Design: Melissa Herkt on The Case for PAT and QbD at the May 11-12 2010...
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The opinions expressed here are the personal opinions of the authors. Content published here is not read or approved by Emerson before it is posted and does not necessarily represent the views and opinions of Emerson.