Posted on 06 September 2011.
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.
Posted in Readers' Choice, Resources
Posted on 01 February 2011.
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.
Posted in Expert Insights
Posted on 14 October 2010.
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.
Posted in Audio & Video, Expert Insights
Posted on 20 September 2010.
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.
Posted in Expert Insights, Resources
Posted on 30 March 2010.
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.
Posted in Resources