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CEL-SCI Scientist Invited to Discuss Plans to Launch Unique Manufacturing Process That Saves Cost While Enhancing the Shelf Life of Drugs at 5th Annual Aseptic Processing of Sterile Drug Products Conference
Date:6/16/2009

ology/pharmaceutical companies and academic research institutions. The use of a cold +4 degrees Celsius aseptic fill, as opposed to the room temperature fill usually employed for these and other products, significantly increases the probability of maintaining the biological activity and potency of these drugs, and thus potentially extending the drugs' shelf-life. When launched, CEL-SCI will be the only company providing this "true cold" +4 degrees Celsius filling service on a contractual basis to other companies and academic institutions. CEL-SCI will also be able to offer normal room temperature fills at the same facility.

Dr. Talor said, "Many of the large pharmaceutical and generic companies are getting ready for new biosimilar legislation in the US. They have invested a great deal of effort and money in this area. However, as best we know, none have "true cold" fill capability that will allow them to bring these drugs to market faster, while saving substantial cost. We believe that we will be in an excellent position to work with them to meet their growing needs as they will try to rush new drugs to market."

CEL-SCI's unique, cold aseptic filling suite can be operated at temperatures between 2 degrees Celsius and room temperatures, including humidity control. The Fill/Finish Facility and the aseptic filling suites have all been designed to meet both FDA and EU ISO classifications. CEL-SCI also has additional capability to formulate, inspect, label and package these products at cold temperatures.

Background on CEL-SCI's "true cold" +4 degrees Celsius Fill/Finish facility:

The fastest area of growth in the Biopharmaceutical and Pharmaceutical market is the area of biologics, most recently the area of stem cell derived products, and in the future biosimilars (copies of biologics). These compounds and therapies are derived from or mimic human cells or proteins and other molecules
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SOURCE CEL-SCI Corporation
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