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
Posted on: Tuesday, 16 June 2009, 08:00 CDT
The availability of this unique aseptic filling process developed by CEL-SCI may also significantly accelerate the time to market by eliminating complicated, costly and time consuming validation studies and tests required when these products are filled at room temperature. This process is also likely to save money in the production of follow-on biologics and biosimilars (the general equivalent of generics in the biological arena) likely to be approved in the U.S. soon.
CEL-SCI's new state-of-the-art manufacturing facility near
The Company will employ a process known as "true cold" +4 degrees Celsius Aseptic Filling for products derived from stem cell technology, biotechnology/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 (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 spent on the development of these expensive validations.
About IVT:
The Institute of Validation Technology (IVT) Conference Division features the most-notable validation and compliance experts in the FDA regulated industry. IVT stands alone in its quest to continually educate pharmaceutical, biopharmaceutical and medical device professionals in validation concepts from A-Z, AND global GXP regulatory initiatives. Through over 15 years of providing timely, cutting-edge conferences, IVT's philosophy remains that: "each of our events provides valuable take-home knowledge that can be immediately implemented at every level."
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine(R) which is currently being readied for a global Phase III trial. The Company has operations in
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 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
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SOURCE CEL-SCI Corporation
Source: PR Newswire
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