FDA Initiates Study of QbD for Lyo Protein Product Manufacturing

FDA has released a synopsis of a project to study the development of QbD for lyophilized protein parenteral manufacturing. The parties involved in the one-year project include Baxter Pharmaceutical Solutions, Purdue University, University of Iowa, and University of Connecticut.

--Paul Thomas

Public and Private: Janssen Alliance for TB Drug Development May Serve as Model

An interesting note from a few weeks ago on an agreement between Janssen subsidiary Tibotec and the not-for-profit TB Alliance to share resources and expertise. Says the alliance's president and CEO Mel Spigelman, “Since the TB Alliance was founded, we have assembled the largest pipeline of new TB drugs in history . . . " It's a great model for collaboration, cost sharing, and bringing needed drugs to market that otherwise would not have gotten the full resources and backing they deserve.

--Paul Thomas