Ash Stevens, Inc. (ASI) has announced the U.S Food and Drug Administration (FDA) has approved ASI's manufacturing facility in Riverview, Michigan for the manufacture of Amotosalen, the API in Cerus Corporation's INTERCEPT Blood System.
The INTERCEPT Blood System recently received FDA approval for ex vivo preparation of pathogen reduced plasma and platelet components in order to reduce the risk of transfusion-transmitted infection (TTI).
“We are proud to be Cerus Corporation’s outsourcing partner for the development and manufacture of this important API. 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.” Says Dr. Stephen Munk President and CEO of Ash Stevens Inc. This represents ASI’s twelfth manufacturing approval for an innovator or NCE (New Chemical Entity) drug.