VIENNA, Va., March 10 /PRNewswire-FirstCall/ -- CEL-SCI Corporation 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 be operated at temperatures between 2 degrees Celsius and room temperatures, including humidity control. The Aseptic filling suites are maintained at FDA and EU ISO classifications of 5/6. CEL-SCI also has additional capability to formulate, inspect, label and package these products at cold temperatures.
“We developed this unique cold fill technology over the course of many years and built this new facility for our cancer drug Multikine at a cost of about $22 million because we had not been able to find a company that could do a true 4 degrees Celsius cold fill for us. The best they could do was turn the temperature down to 60 degrees Fahrenheit, without the needed humidity control. We have now created something very unique and something that addresses a true need in the market place. Through our new service we will help advance new treatment therapies while also creating substantial shareholder value through the income from the facility,” said Geert Kersten, CEL-SCI’s Chief Executive Officer.
Background of CEL-SCI’s cold 4 degrees Celsius Fill/Finish facility:
The fastest area of growth in the Biopharmaceutical and Pharmaceutical market is the area of biologics, and most recently the area of stem cells. These compounds and therapies are derived from or mimic human cells or proteins and other molecules (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. However, stem cell products and biologics do not generally lose activity when kept at 4 degrees Celsius.
Therefore CEL-SCI has developed a completely novel technology to be able to accomplish the Fill/Finish operation at 4 degrees Celsius (as well as at room temperature if the client so desires). This is of great importance to companies that produce the latest drugs, biologics and stem cell 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 filling a product at CEL-SCI’s new facility at 4 degrees Celsius, minimal to no biological losses will have occurred due to 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 also will need to be tested and validated. Therefore CEL-SCI’s new cold fill facility will provide several critical advantages to companies developing Biologics and stem cell 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 spent on the development of expensive validations.
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine(R) which is being readied for a global Phase III trial. The Company has operations in Vienna, Virginia, and Baltimore, Maryland. CEL-SCI’s other products, which are currently in pre-clinical stage, have shown protection against a number of diseases in animal tests and are being tested against diseases associated with bio-defense and rheumatoid arthritis.
When used in this report, the words “intends,” “believes,” “anticipated” and “expects” and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company’s potential products, inability to raise the necessary capital to achieve the planned objectives and the risk factors set forth from time to time in CEL-SCI Corporation’s SEC filings, including but not limited to its report on Form 10-K/A for the year ended September 30, 2008. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460
Web site: http://www.cel-sci.com//
