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-12364760-B2
Publication Date
2025-07-22
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 pathogen-inactivation methods and improved whole blood compositions by performing pathogen reduction on oxygen-reduced, and optionally carbon-dioxide-reduced, whole blood collected in citrate phosphate dextrose (CPD). The methods combine inclusion of a photosensitizer (primarily riboflavin) and ultraviolet irradiation [procedural detail omitted for safety] while the blood has reduced dissolved gases. Processing and product forms include leukoreduced whole blood and related blood component variants.
The specification also provides an alternative pathogen-inactivation chemistry using S-303 with glutathione under oxygen- or oxygen-plus-carbon-dioxide-reduced conditions. Devices and consumables enable gas reduction and anaerobic storage, including barrier bags, oxygen absorbers, deoxygenation modules, and UV irradiation chambers or windows. The invention encompasses anaerobic storage of the treated, reduced-gas blood products to preserve quality.
The background identifies that standard pathogen inactivation and storage processes are associated with increased microparticle formation, elevated hemolysis, declines in ATP and 2,3‑DPG, reduced deformability, and other storage lesion metrics. The invention addresses these problems by reducing oxygen, and optionally carbon dioxide, prior to pathogen reduction to improve multiple quality metrics and to enhance pathogen-inactivation efficacy when combined with certain chemistries.
Claims Coverage
The independent claims cover oxygen-reduced and oxygen-and-carbon-dioxide-reduced CPD whole blood, each characterized by inclusion of a photosensitizer (riboflavin) and UV irradiation for pathogen inactivation.
Oxygen-reduced whole blood collected in CPD
Whole blood collected in citrate phosphate dextrose (CPD) that is oxygen reduced, comprises riboflavin as a photosensitizer [procedural detail omitted for safety], and has been irradiated with UV light for pathogen inactivation [procedural detail omitted for safety].
Oxygen- and carbon dioxide-reduced whole blood collected in CPD
Whole blood collected in citrate phosphate dextrose (CPD) that is oxygen and carbon dioxide reduced, comprises riboflavin as a photosensitizer [procedural detail omitted for safety], and has been irradiated with UV light for pathogen inactivation [procedural detail omitted for safety].
The independent claims principally combine gas-reduced CPD whole blood with inclusion of a photosensitizer (riboflavin) and UV irradiation to provide pathogen-inactivated blood, with embodiments that further tighten gas thresholds and assert improved quality outcomes relative to non-reduced CPD whole blood.
Stated Advantages
Substantially reduced hemolysis of pathogen-inactivated blood products compared to non-gas-reduced CPD whole blood.
Multi-fold reductions in microparticle formation during storage of pathogen-inactivated blood products compared to non-gas-reduced CPD whole blood.
Improved cellular quality metrics including higher ATP and 2,3‑DPG and improved red cell deformability.
Improved efficacy of S-303 pathogen inactivation when used in combination with oxygen reduction and glutathione.
Enables extended shelf life of pathogen-reduced blood products with extended preservation of quality.
Documented Applications
Pathogen inactivation of whole blood and blood components using gas-reduced processing combined with photosensitizer addition and UV irradiation.
Alternative pathogen-inactivation chemistry using S-303 with glutathione under oxygen- or oxygen-plus-carbon-dioxide-reduced conditions.
Anaerobic storage of oxygen- and/or carbon-dioxide-reduced, pathogen-inactivated whole blood to preserve quality metrics during storage.
Use of devices and consumables for deoxygenation and anaerobic storage of blood products, including barrier bags, oxygen absorbers, deoxygenation modules, and UV irradiation chambers or windows.
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