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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

(e.g., hormones, etc.). Nearly all of the major new billion-dollar-drugs developed for unmet medical needs (e.g., Avastin, Erbitux, Rituxan, Herceptin, Copaxon, etc.) are biologics. Biologics are usually very sensitive to heat and quickly lose their biological activity if exposed to room or elevated temperature for various periods of time. These elevated temperatures may also affect the shelf life of a Biologic product, which means that the product cannot be stored for as long as one might find desirable.

Therefore, CEL-SCI has developed a completely novel technology to be able to accomplish the aseptic Fill/Finish operation at "true cold" +4 degrees Celsius. This is of great importance to companies that produce the latest drugs, biologics and stem cell derived therapies. It is an absolute requirement by FDA and any other regulatory agency that a drug developer must demonstrate the safety, purity and potency of a drug being produced for use in humans.

When aseptically filling a product at CEL-SCI's new facility at +4 degrees Celsius, minimal to no biological losses will have occurred due to the maintenance of cold temperature, and therefore the potency of the drug is maintained throughout this final critical step of the drug's manufacturing process. When the same temperature sensitive drug is instead aseptically filled at room temperature, very expensive and time consuming validation studies must be conducted, first, to be able to obtain a complete understanding of the product's potency loss during the room temperature fill process, then to create solutions to the drug potency losses, which then will also need to be tested and validated. Therefore, CEL-SCI's new "true cold" aseptic fill facility will provide two critical advantages to companies developing biologics and stem cell derived therapies: it will save them a great deal of money (wasted product and extra validations) and it will save them a great deal of time usually s
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