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The vast majority of biologics either approved or in clinical development require refrigeration to retain their structural integrity and biological activity. The maintenance of a cold-chain during transportation from the manufacturing site to distribution centers or to the end users is an expensive and difficult logistical exercise. Furthermore, the need for refrigeration can prohibit or limit the use of biologics as self-administered drugs because patients do not always comply with the required storage conditions. In developing countries where temperature monitored cold storage facilities are in short supply, this is even a bigger problem. The need for refrigeration has a significant impact on the cost of medication in general.
Arecor has been working with the Program for Appropriate Technology in Healthcare (PATH), a non-profit organization based in Seattle Washington to develop thermo-stable formulations of essential therapeutics as such as Hepatitis B vaccine (Hep B). Arecor has developed a new formulation of Hep B vaccine that is stable at 37°C for over 12 months with only minimal loss of antigenic activity. The new vaccine has been licensed to a company located in India who are progressing the formulation as a commercial candidate. Other thermo-stable liquid formulations in various stages of development include Hib vaccine, Erythropoietin, Clotting Factors, Insulin and Human Growth Hormone.
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ArestatTM comprises two fundamentally different aspects of our platform stabilization technology. Both utilize excipients and buffers approved by the FDA and EMEA in an unconventional manner to achieve the desired stability
Both platform technologies are available for licensing for applications involving therapeutic proteins, vaccines, medical devices and diagnostics
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