By Agnes Shanley

A presentation at IFPAC last Thursday brought on some heated debate about the Design Space, and  just how dynamic it can, or should, be.  Should any changes due to unanticipated “real world” situations necessarily trigger the development of a new design space, and post-approval change filings and more testing?

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In what might be called an “instant classic,” a team of authors from Bristol-Myers Squibb Process Research and Development has published, in the Journal of Pharmaceutical Innovation, a comprehensive study on Utilizing Mechanistic and Empirical Modeling in Quality by Design. “In this case study, we present an approach for employing modeling to help define the design space for a reaction with potential to generate an impurity that could impact the quality of an API,” the abstract explains. The approach consists of evaluating reaction parameters and developing assumptions, developing the mechanistic model to predict the impurity, creating and veriftying a design space.ide parameters ranges for manufacturing flexibility. The BMS team offers ample illustrations of the work done throughout these various stages.

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Earlier this month, ISPE and PDA cosponsored three days of workshops with the ICH Quality Implementation Working Group (Q-IWG) related to improving participants’ understanding of ICH Q8, Q9, and Q10 guidelines and their implementation. For those unable to attend, the training materials are now available in full, in pdf form, on ISPE’s web site.

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Drug development experts continue to wrestle with the concept of the Design Space. Someone with a knack for explaining complex concepts such as Design Space in plain terms is Bikash Chatterjee, CTO of Pharmatech Associates. As such, we’ve pulled the videos below, in which Bikash tackles questions related to Design Space, out of our vaults.

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From time to time on this site, we’ll reflect upon articles that we feel have been particularly noteworthy in explaining some aspect of Quality by Design, and in advancing the movement. Sort of a Greatest Hits of QbD, if you will. (We would love to hear your nominations for this “album”. Send suggestions for classic articles from any publication or web site to pthomas@putman.net or ashanley@putman.net.)

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Whether you’re bound for the beach, the mountains, or the office, why not take along some summer reading? We’ve compiled a list of some of the more noteworthy QbD-related articles and items to be published this summer from various sources. Upload them to your laptop, or print them and put them in your suitcase. And let us know if you have QbD reading suggestions as well.

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