Anaerobic blood storage and pathogen inactivation method
Inventors
Sowemimo-Coker, Samuel O. • Sutton, Jeffrey • Yoshida, Tatsuro
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
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-11911471-B2
Publication Date
2024-02-27
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 reduces oxygen in whole blood prior to pathogen inactivation to reduce hemolysis and microparticle formation and to extend shelf life. The approach combines oxygen reduction with subsequent pathogen reduction using a photosensitizer (riboflavin) and irradiation [procedural detail omitted for safety], or an alternative pathogen inactivator S-303 with a thiol additive (glutathione). Anaerobic storage with oxygen and optionally carbon dioxide control maintains product quality and preserves biochemical and cellular endpoints during storage.
Pathogen-reduction treatments can increase hemolysis and microparticle formation and thereby limit storage life, and reducing oxygen prior to treatment addresses this problem. The disclosure describes deoxygenation methods [procedural detail omitted for safety] integrated with pathogen-reduction workflows, including riboflavin plus UV and S-303 plus glutathione. The intended outcome is improved storage stability and reduced cellular damage during and after pathogen reduction.
Pathogen-reduced whole blood that is not oxygen reduced exhibits increased microparticles, increased hemolysis, loss of ATP and 2,3-DPG, altered deformability, and higher residual pathogen levels during storage. Lowering oxygen before pathogen reduction and maintaining reduced oxygen during storage preserves biochemical and cellular endpoints and lowers residual pathogen concentration. The approach is described for whole blood and derived components.
Claims Coverage
The patent includes one independent claim that recites four main inventive features.
Oxygen reduction of whole blood prior to pathogen reduction
Reducing oxygen from whole blood to prepare an oxygen reduced whole blood product having an oxygen saturation (SO2) of [procedural detail omitted for safety].
Addition of riboflavin as photosensitizer
Adding riboflavin to the oxygen reduced whole blood product to [procedural detail omitted for safety] as part of the pathogen reduction process.
UV irradiation for pathogen reduction
Irradiating the riboflavin-containing whole blood product with UV light [procedural detail omitted for safety] to reduce blood pathogens.
Microparticle reduction performance
Obtaining a reduction in microparticles by between 20 and 60% relative to a whole blood product from which blood pathogens are reduced and oxygen is not reduced.
The independent claim covers deoxygenating whole blood prior to riboflavin-mediated UV pathogen reduction to achieve specified reductions in microparticles and preserve product quality during storage.
Stated Advantages
Approximately 20–50% (and up to ≥50%) reductions in hemolysis versus pathogen-treated blood that is not oxygen-reduced.
Two- to nine-fold reductions in microparticles over storage (reports up to 9-fold at 2–6 weeks).
Potential shelf-life extension by 1–3 weeks while keeping hemolysis below regulatory limits (≤0.8–1.0%).
Improved biochemical quality endpoints such as ATP and 2,3-DPG.
Improved cellular deformability and reduced phosphatidylserine exposure.
Lower residual pathogen levels in treated whole blood.
Improved overall storage quality of whole blood products under reduced oxygen conditions.
Documented Applications
Improving storage quality of whole blood by reducing oxygen prior to pathogen inactivation to reduce microparticle formation and preserve biochemical and cellular endpoints.
Applying the oxygen reduction approach in combination with riboflavin-based photochemical pathogen reduction.
Applying the oxygen reduction approach in combination with alternative pathogen inactivators (S-303 with a thiol additive) to reduce hemolysis and microparticles and improve storage outcomes.
Storage of oxygen-reduced, pathogen-reduced whole blood under reduced-oxygen conditions to maintain product quality during storage.
Whole blood and derived components including leukoreduced packed red blood cells (LRpRBCs), plasma, and platelets.
Compatibility with Mirasol, Hemanext, and other pathogen-reduction systems.
Interested in licensing this patent?