The contract manufacturing organisation (CMO) performed process development and current good manufacturing practice (cGMP) compliant production to support the licensure and has now expanded on this arrangement.
Stephan Kutzer, chief operating officer at Lonza Custom Manufacturing APIs (active pharmaceutical ingredients), said he expects Arzerra to “be a key biopharmaceutical for both companies”.
He added that Lonza has drawn on “the expertise of both companies to develop a state-of-the-art manufacturing process”. Arzerra is a treatment for chronic lymphocytic leukemia (CLL) that recently gained approval from the US Food and Drug Administration (FDA).