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Posts Tagged ‘Quality by Design’

Trends in the Life Sciences Industry

Posted in Life Sciences on Thursday, June 23rd, 2016. 2 comments so far
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For pharmaceutical and biotech manufacturers, trends in the market place are driving changes in the way they have historically operated their production processes. I caught up with Emerson’s Michalle Adkins who shared these trends with me. She identified six major areas: continuous manufacturing, single use technology, biosimilars & generics, personalized medicine, demographic shifts, and taking […]

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 Process Analytical Technology and Continuous Process Verification

Posted in Data Management, Life Sciences on Tuesday, August 12th, 2014. One comment so far
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In the 4:42 video, Life Science Drug Process Development and Manufacturing, Emerson’s Gary Mitchell highlights the changes occurring for pharmaceutical and biotech manufacturers. Gary opens noting how these manufacturers are challenged to respond to new methods for drug process development and manufacturing. The U.S. Food and Drug Administration (FDA) is driving manufacturers in the Life […]

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 […]