RIVERVIEW, Mich., Jan. 28, 2015 /PRNewswire/ -- Ash Stevens, Inc. (ASI), a leading provider of global contract pharmaceutical drug substance development and API (Active Pharmaceutical Ingredient) manufacturing services, is pleased to announce 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 (NASDAQ: CERS) 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.
About Ash Stevens, Inc.
Ash Stevens, Inc. (ASI) is a full service Contract Pharmaceutical Manufacturer offering comprehensive small-molecule drug substance development and cGMP manufacturing services. Founded in 1962 and headquartered in Riverview, Michigan, ASI has extensive experience developing and manufacturing Active Pharmaceutical Ingredients (APIs) for commercial clients in the Life Sciences industry developing innovator small-molecule therapeutics. ASI is a longtime provider of contract research services to the National Institutes of Health and the National Cancer Institute and has participated in the development of many of important drugs through these government agencies. To date, ASI has received twelve FDA manufacturing approvals for innovator APIs, including four Fast Track manufacturing approvals for the active ingredients in the oncology drugs Velcade®, Vidaza®, Clolar® and Iclusig®. Services offered by Ash Stevens include: process development and scale-up; cGMP manufacturing (fixed equipment from 100 liters to 4,000 liters); the development and cGMP manufacture of highly potent APIs using barrier-isolation technology; comprehensive analytical capabilities (including method development, stability studies and qualification of reference standards); and regulatory support for all phases of drug development and manufacturing.
For more information, visit www.ashstevens.com or contact:
Dr. James Hamby, Vice President of Business Development [email protected]
SOURCE Ash Stevens, Inc.