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Many biopharmaceuticals are only available as powders for reconstitution. This often limits the convenience of use and can sometime result in dosing errors. This is particularly the case for self-administered drugs.
Arecor has successfully applied the Arestat-T™ technology to a number of important self administered proteins presently only available as powders. The clotting factors, in particular Factors VIII and IX are a good example. Both clotting factors are used in the treatment of Hemophilia, a genetic disorder which leaves sufferers with an inability to form blood clots. Consequently, during bleeding episodes hemophilia sufferers are infused with a therapeutic dose of reconstituted Factor VIII or IX through an intravenous delivery device. With every bleeding episode there is an increased likelihood of joint damage which can be avoided through prophylactic administration of the clotting factors. To make this practice widespread and more user-friendly there is a need for stable aqueous formulations. In conjunction with the National Institute for Biological Standards and Control (NIBSC), Arecor has developed aqueous formulations of Factors VIII and IX demonstrating that powder formulations can be replaced by stable liquids and potentially impact the dosing cycle and treatment regime.
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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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