VIENNA, Va., March 10 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE Alternext US: CVM) announced today that it is planning to launch a new manufacturing process that could allow drugs developed using stem cells and other biological products to maintain their potency and thereby potentially also their shelf life. The availability of this new process developed by CEL-SCI may also significantly accelerate the time to market by eliminating complicated and time consuming validation studies and tests required when these products are filled at room temperature.
CEL-SCI's new state-of-the-art manufacturing facility near Baltimore, Maryland, where it expects to manufacture its lead cancer product Multikine(R) for a pivotal Phase III trial, will be used for the process known as cold 4 degrees Celsius Aseptic Filling on a contract basis to stem cell and biologic companies, academic institutions and commercial media suppliers. The facility will allow CEL-SCI to perform cold 4 degrees Celsius aseptic filling of small volume parenteral drug products and sterile media products. The use of a cold 4 degrees Celsius fill, as opposed to the normal room temperature fill, significantly increases the probability of maintaining drug activity, potency and thus potentially extending the shelf life of new biological and stem cell produced products. CEL-SCI will be the only company providing this cold 4 degrees Celsius filling service on a contract basis to other companies and academic institutions.
Many stem cell derived products are expected to have similar requirements to biologically derived drug products, such as Multikine, allowing CEL-SCI to utilize many of the same clean rooms and production facilities. Many Biologic products benefit from being maintained at refrigerated (cold) temperatures, usually between 2 and 8 degrees Celsius throughout their manufacturing process and storage. CEL-SCI's unique, cold aseptic filling suite can
|SOURCE CEL-SCI Corporation|
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