Zafirelis has more than 25 years of CEO experience in private and public companies, including start-up ventures and turnaround situations. Previously he led two cardiac device class 3 companies, Cardiac Assist Tandemheart and Medquest Products and has significant experience with regulatory agencies worldwide. Serov has over 20 years of experience in the Investment Banking industry.
US8697128B2 - Carbide-derived-carbon-based oxygen carriers - Google Patents
He spent most of his career in London running such groups as capital markets, structured products, and advisory. Before joining Hemoglobin Oxygen Therapeutics, he was heading up coverage for corporate clients and financial institutions at Sberbank, the largest Russian bank. Sunny has led communications for several mergers and acquisitions, and was the architect for the first digital security asset launched by a publicly traded company. Leibensperger has 22 years of experience in Biopharmaceutical Manufacturing and Operations Management.
He was an original team member with Biopure Corp. Leibensperger has a B. Dawson has over 25 years experience working with the development and commercialization of Hemopure and Oxyglobin. Dawson is responsible for the transition of the manufacturing process and components from the Cambridge, MA manufacturing facility to the Souderton, PA manufacturing facility. Dawson started his career with Biopure in and held several positions in manufacturing operations offering broad qualifications in all facets of production, maintenance, calibration, supply chain, process engineering, validation, environmental control, anaerobic aseptic filling, packaging, microbiology and capacity management.
The scope of Mr. He is successful in streamlining production processes, accelerating performance, reducing costs, and meeting time-critical industry demands. Meng is a Hemoglobin specialist with 20 years of research experience in developing hemoglobin-based oxygen carriers HBOCS. Pitman has 20 years of broad based pharmaceutical and healthcare US experience with a strong background in mathematics, statistics and logistics.
Evaluating the Safety and Efficacy of Hemoglobin-based Blood Substitutes | FDA
Previously he has taught courses in mathematics, logic, computer sciences and statistics at various colleges, including the University of Kharkov, Ukraine, Soviet Union. Zafirelis has more than 20 years of multinational regulatory and clinical operations experience. Howes has 19 years of Manufacturing, Validation, and Quality experience. Previously, Serena has worked at such places as Regeneron Pharmaceuticals, Abbott, and Sanofi where she held positions of increasing responsibility such as managing validation groups and leading many lean initiatives to streamline quality CAPA systems, training, and validation processes through Six Sigma and lean continuous improvement tools.
Serena holds a B. Hemopure and Oxyglobin are sourced from bovine red blood cells RBCs. Our quality management system includes a comprehensive herd management program to ensure the safety of all raw material used in production. All sourced cattle are born in the USA or Canada and obtained from pre-qualified suppliers that maintain comprehensive health and feed histories for each animal.
All collected material is held in quarantine until a post mortem inspection of the cattle is conducted by the onsite USDA veterinarian, and released for human consumption. Our products are manufactured by an extensive purification procedure. The purification of hemoglobin involves an automated state-of- the-art process consisting of multiple separation and filtration steps including specific hemoglobin isolation by large-scale, high-pressure ion exchange liquid chromatography.
During the manufacturing process hemoglobin is crosslinked and polymerized by reaction with glutaraldehyde under totally automated procedures. We have recently consolidated all manufacturing activities at our site in Souderton PA, where the facility is undergoing a multimillion dollar expansion to accommodate increased capacity for all production steps from collection of starting materials through aseptic fill finish.
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Oxygen is indispensable to the life of all human tissues. Medical conditions such as ischemia or anemia can compromise tissue oxygenation. Ischemia is a decrease or lack of RBC flow to an organ or body part due to obstructed or constricted blood vessels, as in heart attack, stroke and certain medical procedures. Anemia is a deficiency of RBCs or hemoglobin associated with blood loss e. Oxygen deprivation, even for several minutes, can result in cell damage, organ dysfunction and, if prolonged, death.
The most critical property of each product is an ability to efficiently transport oxygen. There are two mechanisms by which oxygen transport is enhanced. Promoting both convective and diffusive oxygen delivery; the net result is an increase in oxygen delivery due to both an increase in the oxygen-carrying capacity of the plasma, and changes in the rheology of blood. HBOC has a viscosity of 1. Addition of HBOC to blood decreases the overall viscosity.
The products increase plasma and total hemoglobin concentration and thus increases arterial oxygen content. Hemopure is universally compatible and requires no type or cross match prior to intravenous administration through a standard infusion set. Supplied in sterile IV infusion bags, the product is ready to be administered. No reconstitution or other preparation is required. Hemopure also does not need refrigeration and remains stable at room temperature for at least three years.
Liver Transpl. Thompson GA, Greenburg G. The study represents the first ever-clinical application of Hemopure globally for ex situ warm machine perfusion of human donor livers. All 11 patients remain alive from six to 20 months post surgery. Oral presentations conducted at two prestigious conferences; findings have been submitted to an international peer review journal. To date, results show percent transplant and survival rates for all patients.
Scientific advisory board. Led by a team with decades of success. Zaf Zafirelis. Igor Serov. Sunny Uberoi. Bruce Leibensperger. Brian Dawson. Fantao Meng. Arkadiy Pitman. Melissa Zafirelis. Serena Howes. Source of hemoglobin and viral safety. Manufacturing process. Oxygen carrying solutions. Why an oxygen carrying solution? Research areas. Normal blood flow. Hemopure and Oxyglobin have to date been the topic of over peer reviewed journal articles, conference proceeding and posters.
The following reference list includes many of those, but is by no means all inclusive. The references are date ordered with the most recent first:.
Am J Transplant. Synthetic hemoglobin-based oxygen carriers are an acceptable alternative for packed red blood cells in normothermic kidney perfusion. Epub Apr Restoration of brain circulation and cellular functions hours post-mortem. Erratum in: Liver Transpl. Normothermic machine perfusion of donor livers without the need for human blood products. Combined hypothermic and normothermic perfusion for the optimization of injured liver grafts.
Dolgin E. Doing without donors. Stem cells and artificial substitutes could ease the dependence on blood donations. Keipert PE. Adv Exp Med Biol.
- US Army, Technical Manual, TM 55-4610-203-12-1, TRANSPORTABILITY GUIDANCE: WATER PURIFICATION EQUIPMENT SET, TRUCK-MOUNTED, DIATOMIT FILTER, 3000-GALLON PER HOUR,!
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- USB2 - Carbide-derived-carbon-based oxygen carriers - Google Patents.
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Some error has occurred while processing your request. Please try after some time. Artificial oxygen carriers and red blood cell substitutes: A historic overview and recent developments toward military and clinical relevance. Oxygen is transported both physically dissolved in blood and chemically combined to the hemoglobin in the erythrocytes.
Much more oxygen is normally transported combined with hemoglobin than is physically dissolved in the blood. Without hemoglobin, the cardiovascular system could not supply sufficient oxygen to meet tissue demands. Whole blood contains a similar amount of dissolved oxygen per milliliter because oxygen dissolves in the fluid of the erythrocytes in about the same amount. Therefore, normal arterial blood with a of approximately mm Hg contains only about 0. Blood oxygen content is conventionally expressed in milliliters of oxygen per mL of blood, or volumes percent.
If the tissues were able to remove the entire 0.