Tag Archive | "biopharmaceutical QbD"

Pfizer Examines QbD for Freeze-Thaw of Biologics


With the aim of reducing the time and cost of storing frozen biologics, Pfizer Andover-Mass. scientists Angela Kantor, Serguei Tchessalov, Shannon MacMillan, Kin Ho, and Nicholas Warne have developed a framework for freeze-thaw based upon principles of Quality by Design. Their work has been published in a two-part series in American Pharmaceutical Review.

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(Can Biopharma Ever Be) Crazy Like a Fox?


By Ali Afnan, Principal, Stepchange Pharma

As many of you know, I’ve spent years advocating the use of real-time process monitoring and control in the pharmaceutical industry. And, as any of you who have read my articles may have noticed, I’ve been disappointed by the fact that process analytical technology (PAT) has, so far, failed to become routine for most drug manufacturers.

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Audio: Answers to Your Bio QbD Questions


Just posted on the web: As part of BioPharm International‘s regular podcast series, editor in chief Laura Bush leads a roundtable Q&A with some of the industry’s leading QbD experts: Lilly’s John Towns, Amgen’s Duncan Low, and Merck’s Beth Junker and Mike Kosinski.

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Using Design of Experiments to Optimize Chiral Separation


By Robert Tinder, Principal Scientist, Roche Pharmaceuticals

Editor’s Note: The author joined Roche in July 2010; the work discussed in this article took place previously at Wyeth Pharmaceuticals.

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Bio QbD at Pfizer, Genentech: From Concept to Implementation


By Paul Thomas, Senior Editor

Think QbD is daunting? Double that for the biotech arena, where the size and complexity of molecules and the difficulty in defining the attributes that determine quality and safety mean that QbD boils down to a science of educated guesswork.

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