SAN DIEGO, Nov. 16, 2016 /PRNewswire/ -- USPTO has issued a patent for a novel manufacturing process, "Preservation by Vaporization" (PBV), invented by Dr. Victor Bronshtein, Founder, President and Chief Scientific Officer of Universal Stabilization Technologies, Inc. (UST). This invention eliminates the need for the cold chain during storage, distribution and delivery of labile biotherapeutics. Additionally, it allows the product to be micronized into powders suitable for administration by respiratory, transdermal, oral, intravaginal, or other mucosal delivery routes, eliminating the need for both reconstitution and needle injection.
PBV can be used to preserve live attenuated vaccines (LAV) and other labile biologics, endowing them with the ambient temperature (AT) stability that is typically only possible with pharmaceuticals. Despite years of optimization, conventional freeze drying and spray drying methods have been unable to successfully thermostabilize LAVs and many other fragile biopharmaceuticals. For this reason, most fragile biopharmaceuticals, probiotic bacteria, blood-derived products, and enzyme based diagnostics, preserved using conventional drying methods, require a well-controlled cold chain to retain potency and activity. Lack or breakdown of refrigeration for vaccines results in billions of dollars' worth of product loss during shipping and storage, and severely limits distribution to developing nations that lack infrastructure for electricity and refrigeration. Cold chain requirements are estimated to account for over 80% the cost of vaccine implementation, an expense of $200-$300 million annually for vaccination programs. Thermostable biotherapeutics, manufactured via the alternative PBV method, can alleviate these major economic and logistical burdens, which present challenges especially to developing nations.
The novel PBV process is the cornerstone of UST's VitriLife® platform for formulation and production of thermostable LAVs and biopharmaceuticals immobilized in foamed carbohydrate glasses for long-term AT stability. PBV-enabled thermostability and alternative delivery methods are important differentiating factors for production of biobetter vaccines and other biologics. Thermostable biobetters have the potential to take a large market share of the multibillion dollar biosimilars market.
UST is a privately held San Diego-based biopharmaceutical R&D company focused on the formulation of long-term ambient temperature stable biopharmaceuticals. UST offers VitriLife® research and development services for its customers as well as formulation of oral, respiratory, transdermal, sublingual, and other delivery devices for AT stable vaccines and other biopharmaceuticals.
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SOURCE Universal Stabilization Technologies, Inc.