Anaerobic blood storage and pathogen inactivation method
Inventors
Sowemimo-Coker, Samuel O. • Sutton, Jeffrey • Yoshida, Tatsuro
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Assignees
Member
HemanextHemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.
Hemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.
Publication Number
US-11147876-B2
Publication Date
2021-10-19
Expiration Date
Abstract
A method for reducing hemolysis and microparticle formation during storage of pathogen reduced blood. Oxygen reduced blood compositions comprising SAGM and riboflavin having reduced hemolysis. Oxygen reduced blood compositions comprising SAGM and riboflavin having reduced microparticles. Oxygen and pathogen reduced blood compositions comprising CPAD and riboflavin having reduced hemolysis. Oxygen and pathogen reduced blood compositions comprising SAGM and riboflavin having reduced microparticles.
Core Innovation
The invention provides a method that pre-reduces oxygen in whole blood or red blood cell containing products prior to pathogen inactivation to yield improved red cell quality. Removing oxygen to prepare an oxygen reduced blood product precedes pathogen reduction using riboflavin photochemistry combined with UV irradiation [procedural detail omitted for safety] and alternatively S-303 alkylator chemistry [procedural detail omitted for safety]. The method reduces blood pathogens while reducing hemolysis.
The background identifies that performing pathogen reduction in the presence of oxygen contributes to red cell damage, including increased microparticle formation, elevated hemolysis, loss of ATP and 2,3-DPG, and reduced deformability. The invention addresses this by reducing hemolysis and microparticle formation relative to oxygenated controls, improving ATP, 2,3-DPG and deformability, extending shelf life, maintaining hemolysis below regulatory limits, and showing decreases in microparticle counts over storage periods.
Claims Coverage
The patent discloses one independent claim that contains three main inventive features related to oxygen reduction, pathogen reduction using riboflavin and UV irradiation, and a reduction in hemolysis relative to non-oxygen reduced products.
Oxygen reduction of red blood cell containing blood product
Removing oxygen from a red blood cell containing blood product to prepare an oxygen reduced blood product having an oxygen saturation (SO2) below a defined level.
Pathogen reduction using riboflavin and UV irradiation
Reducing blood pathogens from the oxygen reduced blood product by adding riboflavin and irradiating with UV light at defined parameters [procedural detail omitted for safety] to prepare a pathogen reduced and oxygen reduced red blood cell containing blood product.
Reduced hemolysis compared to non-oxygen reduced product
Wherein hemolysis in the pathogen reduced and oxygen reduced red blood cell containing blood product is reduced compared to a pathogen reduced blood product that is a non-oxygen reduced blood product.
The independent claim centers on performing pathogen reduction on an oxygen reduced red blood cell containing product using a riboflavin plus UV approach and on the resulting reduction in hemolysis relative to pathogen reduction performed in the presence of oxygen.
Stated Advantages
Reduced hemolysis compared to oxygenated pathogen-reduced blood products.
Markedly lower microparticle (microvesicle) formation relative to oxygenated controls.
Maintenance of hemolysis below regulatory limits.
Extension of shelf life while preserving red blood cell quality.
Improved metabolic parameters including increased ATP and 2,3-DPG levels.
Improved red cell mechanical quality, including enhanced deformability and reduced phosphatidylserine exposure.
Documented Applications
Whole blood.
Leukoreduced whole blood.
Packed red blood cells.
For use in blood transfusion.
Treatment to inactivate viruses, bacteria, parasites and residual leukocytes while preserving red blood cell quality and extending shelf life.
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