New Enhanced Protein Stability Technology will be introduced at AAPS by BioPhysix and University of

BioPhysix (Orange, CA) and University of Texas at Austin (UT-Austin) today announced important breakthroughs in the stabilization of therapeutic proteins that maintains their bioactivity and physical properties at both elevated and freezing temperatures for extended periods. Stabilized proteins also exhibit long-term stability at ambient temperatures.

Aimed at extending shelf life of protein therapeutics and eliminating restrictive and expensive storage conditions, these technologies open up third-world markets that have inadequate distribution and refrigeration facilities. It also helps alleviate expensive recalls and can be used to extend patent life. This stabilization technology also cuts the costs of administration, storage, and the costly disposal of therapeutics past their expiration date, benefiting hospital, government and country health administrations.

Dr Robert (Bill) Williams and Dr Keith Johnston, UT-Austin, in conjunction with the BioPhysix team, Dr Roy Dittman, Alyson Wlitherspoon and Dr Courtney Anderson are presenting three posters on this patented Imprex(tm) technology at the upcoming American Association of Pharmaceutical Scientists (AAPS) convention in Salt Lake City (October 27-30).

Model compounds studied have included both large and small protein drugs such as Bovine Serum Albumin (BSA), Lysozyme and Human Growth Hormone, respectively, as well as unstable protein drugs such as Insulin and Calcitonin. The Imprex(tm) stabilization process generates uniform sub-micron particles with specified sizes. These nanospheres can be formulated as liquid emulsions in an anhydrous environment. The resultant nanotechnology product is amiable to incorporation in microspheres and depot release formulas and into a host of needle-free delivery methods.

The nanospheres and anhydrous formulations are stable at high and low temperature extremes and maintain their bioactivity, unlike unstabilized protein formulations.

BioPhysix, whose mission is to use the Imprex(tm) stabilization technology to increase the worldwide distribution of important protein therapeutics, is forming venture partnerships with a number of biopharmaceutical companies with therapeutic protein stability issues. These partners use BioPhysix' technology to extend their distribution into third world countries, save on costly recalls, extend shelf live and extend patent life.