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.