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

Tech Transfer Blues: U of Iowa Sues Abbott Over Humira

The University of Iowa's research arm has filed an intellectual property lawsuit against Abbott Labs, saying that the company had "willfully and deliberately" infringed on its patents that have been essential in the manufacturing of Humira. Abbott, not surprisingly, says it has done no wrong and will "vigorously defend" itself. GenomeWeb has the story. Stay tuned . . .

--Paul Thomas