VirTech Bio Development Lab
Leading the way in the development of human-derived HBOC solutions.
Meeting the still unmet need for a temporary blood substitute with better science: a new human hemoglobin megapolymer
The analytical and process development lab team developed a novel formulation, a “next generation” polymer of hemoglobin that is large enough to prevent extravosation, or leakage out of the blood vessels, which causes them to constrict. The patented formulation is designed not only to deliver oxygen but to have viscosity properties and osmotic properties similar to blood to protect the blood vessels and avoid fluid shifts – all issues seen with previous HBOC generations which were not approved. The team developed a highly reproducible scalable manufacturing process designed to yield a room-temperature stable product and enable transfer to a contract manufacturer, saving time and reducing manufacturing facility costs. That transfer has now occurred!
Experience Matters.
VirTech Bio assembled a scientific team comprised of scientists who were directly involved with almost all the prior generations of HBOCs that progressed to clinical trials. Each member has decades of experience in this field. Their combined “lessons learned” from prior scientific and commercial efforts, and their dedicated persistence, represent a unique resource on which to build this company. The team is led by the former head of the US Army’s Combat Casualty Care Research Program who was first a trauma physician. The team’s experience and potential to succeed where others have failed is unmatched.
Making the Vision Real
The VirTech Bio Development Lab has helped engineer OxyBridge to be scalable, readily manufacturable and practical for emergency services: long shelf life with no refrigeration requirements.
Product Development Approach
First product – in vivo:VirTech Bio has developed OxyBridge™ for treatment of hemorrhagic shock. OxyBridge is a concentrated hemoglobin solution containing 100 grams of hemoglobin per Liter, which carries nearly as much oxygen as fresh whole blood. Human hemoglobin is ultra-polymerized in a patented process to form a megapolymer which circulates for many hours, restoring oxygen delivery to critical tissues.
Second product – ex vivo:OxyBridge™ is also under development as a perfusion solution for use with organ perfusion devices that support donor organs prior to transplant. For this second product the polymerized hemoglobin is added to a solution of electrolytes that is similar to what is currently used with such devices. The hemoglobin solution transports oxygen to the organ to increase viability of the organ prior to transplant and is considered a device for this application. Successful pre-clinical studies have been published and the product for this device indication is likely to be the first to market.
Third product – Veterinary:A polymerized hemoglobin product was approved by FDA for veterinary use 25 years ago and rapidly adopted by veterinary surgeons, but the manufacturer is no longer in business. VirTech Bio is developing a similar product to meet the needs of veterinary surgeons and for field use in the military’s K-9 soldiers. Although OxyBridge™ has been tested in animal models of hemorrhage successfully, and may be utilized for the military’s K9 soldiers, the eventual veterinary product is expected to be a smaller polymer of hemoglobin than OxyBridge and will be less expensive to produce.
Fourth product – Research:An oxygen carrying solution is needed by researchers developing tissues and organs in the laboratory, either as alternatives to transplant or for drug testing as alternatives to animal models. Once these biofabricated tissues and organs reach a certain scale, they generate an oxygen demand that exceeds what diffusion alone can meet. A stable hemoglobin solution can be used to facilitate oxygen diffusion in these systems and can be marketed as a reagent.