Tag Archive | "BMS"

Memoirs from IFPAC 2012

By Emil Ciurczak, Contributing Editor

Sunday, January 22, 2012

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Envelope Please: AIChE Hands Out QbD Awards

In Minneapolis on Tuesday night, Joe Hannon, CEO of Scale-up Systems (DynoChem), noted how the Quality by Design track at this year’s AIChE annual meeting in Minneapolis was “more like going to M.I.T. than Las Vegas”–substance over glamor, in other words.

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BMS’ Tabora: For PAT and QbD, the Exotic is Becoming Routine

By Paul Thomas, Senior Editor

On October 18 in Minneapolis, Dr. Jose Tabora of Bristol-Myers Squibb will be honored with the 2011 AIChE Award for Outstanding Contribution to Quality by Design for Drug Substance. The award is sponsored by DynoChem Inc., the North American subsidiary of Scale-up Systems Limited. (Two other awards—one for QbD for Drug Product, sponsored by Pfizer, and one for Excellence in Integrated QbD Practice, sponsored by Merck—will also be handed out that evening. More on those recipients to come soon.)

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QbD Classics: Comparing Mechanistic and Empirical Models at BMS

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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Paul McKenzie: Bringing Order to Complexity at J&J

Editor in Chief Agnes Shanley recently spoke at length with Paul McKenzie, global head of pharmaceutical development and manufacturing sciences for J&J pharmaceutical research and development. McKenzie shared his goals for J&J’s pharmaceutical R&D, specifically its “Lab to Patient” program. He also discussed how pharmaceutical data visibility and access might be improved, throughout the value chain and across functions.

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