Commercial-scale Preservation of Therapeutically-active Stem Cell-derived Products For Worldwide Marketplace Opportunities
SAN DIEGO—March 24, 2015—Stemedica Cell Technologies Inc., (Stemedica), announced today that Universal Stabilization Technologies (UST) has granted to Stemedica subsidiary StemProtein, LLC, an exclusive worldwide license to its technology known as Preservation by Vaporization (PBV) for industrial scale stabilization of stem cells and stem cell derivatives. This license will allow Stemedica and StemProtein to manufacture stem cell-secreted therapeutic proteins in a VitriLife™ state, that remain shelf stable and therapeutically active at ambient temperatures for two or more years.
“UST’s technology immediately accelerates Stemedica’s development of a wide range of products containing stem cell factors for consumer and medical markets worldwide,” said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer. “PBV significantly improves the bioactivity of preserved stem cell factors for reconstitution in many forms – from powders to gels, from bandages to liquids. PBV-preserved proteins are superior in activity compared to lyophilized proteins.” Stemedica products currently in development include eye drops, inhalable dry powders, wound dressings, injectable (parenteral) solutions, nose drops, sublingual tablets and a variety of skincare and dental products. “In addition to the significant consumer opportunities, we are optimistic about the role stabilized products may have in helping to treat a number of medical conditions including skin damage, eye diseases, cardiovascular and neurological conditions and in working to prevent or to slow down disease development such as Alzheimer’s disease,” said Dr. Tankovich.
UST’s Preservation by Vaporization is a unique technology that preserves the biological activity of stem cell proteins at room temperature and significantly cuts the time and cost of manufacturing compared to conventional methods of preservation while increasing final product yields as reconstituted in its various distribution and packaging forms. PBV technology provides an efficient process for converting stem cell factors into fine powders that retain their natural efficacy for eventual bulk processing and packaging of product for mass consumer and medical markets.
“I am pleased to enter into this collaboration with Stemedica,” said Victor Bronshtein, PhD, founder of Universal Stabilization Technologies and inventor of PBV. “Stemedica’s cGMP manufacturing and its unmatched command of commercial scale-up technologies are cornerstones for manufacturing pharmaceutical and over-the-counter products for consumer and medical markets.”
The patented PBV technology immobilizes biologicals in glassy carbohydrates (a VitriLife™ state) that enables its stable storage and shipping without refrigeration. PBV preserves a mixture of macromolecules that are secreted by stem cells in culture. The thermostable mixture contains sensitive biologicals, such as cytokines, chemokines, growth factors, matricellular proteins, enzymes, mRNAs and microRNAs.
“UST’s propriety dosage format will enable Stemedica’s preserved stem cell products to meet ambient temperature (-20°C to +40°C) shelf-life standards for a pharmaceutical or over-the-counter product,” said Yuri Kudinov, MD, PhD, Vice President of Research at StemProtein. “Thermostable stem cell products will ensure the confidence of patients and prescribing physicians that a product provides the therapeutic activity listed on the label, not merely at the time of manufacture, but at the time of use. This is not the case for many stem cell products now marketed through consumer channels.”
About Universal Stabilization Technologies
Universal Stabilization Technologies, Inc. (UST) is a privately-held service and product development company based in San Diego, CA. UST’s mission is long-term stabilization (preservation) at high ambient temperatures of vaccines and other biopharmaceuticals, probiotics, blood and other cells or cellular components. UST’s patented industrial-scale Preservation by Vaporization (PBV) process technology makes it possible to achieve higher yields after drying and better stability during storage at ambient or even higher temperatures (including 37°C or higher) than is currently possible with conventional techniques such as freeze drying or spray drying. The PBV process has been successfully applied to make thermostable formulations of a wide range of biologics, including probiotic bacteria, live attenuated vaccines for human and animal markets, blood plasma and other blood-derived products. The process is scalable for batch or continuous load operations and can be executed using a conventional freeze dryer.
Founded by Victor Bronshtein, PhD, UST has applied contemporary physics, physical biochemistry and process engineering for development of advanced preservation technologies. The PBV platform extends into numerous business areas: pharmaceuticals, biopharmaceuticals, foods, cosmetics, etc.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty biopharmaceutical company which manufactures best-in-class allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging and ischemic stroke. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California and can be found online at www.stemedica.com.
Biotechnology, bio-therapeutics, biologics, drug delivery, drug formulation, stem cells, stem cell factors, skincare and cosmetics, wound dressing, ophthalmology, pulmonology, neurology, cardiology, VitriLife, foam drying, thermostable
VP, Marketing & Business Development