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Posts Tagged ‘QbD’

Clarifying Design Space, Process Analytical Technology and Quality by Design

Posted in Life Sciences on Wednesday, March 11th, 2015. No comments yet
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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 opportunities where PAT may be implemented, since many of these decisions need to be made early, such as […]

Implementing Quality by Design

Posted in Life Sciences on Thursday, February 20th, 2014. 2 comments so far
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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 process understanding and a risk based approach. This new paradigm uses terminology such […]

Establishing a Process Analytical Technology Program

Posted in Emerson Exchange, Life Sciences on Monday, September 16th, 2013. 2 comments so far
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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 pharmaceutical and biotech manufacturing industries, you may want […]

Avoiding Moisture Variability in Fluidized Bed Dryer Operations

Posted in Life Sciences, Project Services on Thursday, June 21st, 2012. 2 comments so far
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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 project to achieve these results was highlighted in a post, Using Operational Excellence […]

Trends in Process Analytical Technology and Quality by Design

Posted in Life Sciences on Tuesday, June 5th, 2012. 2 comments so far
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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 Emerson’s Director of Life Sciences Industry Consulting, Chris Amstutz. Their discussion was captured in this 4:48 YouTube video, Emerson […]