Ash Stevens to manufacture active pharmaceutical ingredient for Cerus
Following FDA approval of Riverview manufacturing facility in Michigan, US
Ash Stevens, a US provider of contract manufacturing services, is to produce an active pharmaceutical ingredient (API) for Cerus.
Amotosalen is used in Cerus' Intercept blood system, which was recently approved by the US FDA for ex vivo preparation of pathogen-reduced plasma and platelet components to reduce the risk of transfusion-transmitted infection (TTI).
Ash Stevens' Riverview, Michigan, US facility has also been approved by the FDA for the manufacture of this product.
Stephen Munk, President and CEO of Ash Stevens, said: 'We have had a collaborative and highly productive relationship with Cerus for many years and we are excited to help provide this innovative product to patients. This is a particularly heartwarming approval for me as I witnessed the fundamental research which led to this important product during my time as a graduate student in Professor Henry Rapoport’s lab at The University of California, Berkeley.'
This represents Ash Stevens' 12th manufacturing approval for an innovator or NCE (New Chemical Entity) drug.
