New details have begun to emerge about Cel-Sci Corporation's (NYSEMKT:CVM) new, state-of-the-art "Cold-Fill" manufacturing facility which will not only be used to manufacture Multikine® the world's first immunotherapeutic agent (which is being developed as a first-line standard of care treatment for cancer) for both the Phase III trials and commercial sales, but Cel-Sci plans to offer the use of the facility as a service to pharmaceutical companies and others, particularly those that need to "fill and finish" their drugs in a cold environment (4 degrees Celsius, or approximately 39 degrees Fahrenheit).
This is a key process of filling injectable drugs in a sterile manner and is an important part of the manufacturing process for many medicines.
This lab, which many now consider a cornerstone to the future financial success of the company is located near Baltimore, MD. According to newly released documents filed with the SEC, it was designed over several years, and was built out to Cel-Sci's specifications during the past 18 months.
One insider calls it "absolutely state-of-the art" and "extremely impressive down to the smallest detail."
An interview between Cel-Sci's CEO, Geert Kersten, has been scheduled and more details will follow at BioMedReports, but I can tell you that Cel-Sci believes it will be able to charge approximately $150,000 for an eight hour fill and finish "run" at this extremely unique facility whose aseptic filling suites are maintained at FDA and EU ISO classifications of 5/6.
Cel-Sci also has the capability to formulate, inspect, label and package biologic products at cold temperatures. Furthermore, the company discloses that they do not know of any other facility in the United States which is able to provide cold 4 degrees Celsius finish and fill services on a contract basis.
What this will mean for the financial security and future of the company is significant, particularly given the fact that the fastest area of growth in the biopharmaceutical and pharmaceutical markets is biologics, and most recently stem cell products.
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 drugs developed for unmet medical needs (e.g., Avastin(NYSE:R), Erbitux(R), Rituxan(R), Herceptin(R), Copaxon(R), etc.) are biologics. Biologics are usually very sensitive to such things as heat and humidity and are known to quickly lose their biological activity if exposed to room or elevated temperatures (which may also affect the shelf-life of a biologic - with the result being that the product cannot be stored for as long as desired).
These products do not generally lose activity when kept at 4 degrees Celsius.
Shares of Cel-Sci continue to tick upward as signs point to a resurrection of sorts for this biotech play that many had on the ropes and ready for a knock-out punch.
Disclosure: No Positions