# US 12,214,093 B2 · Pathogen reduced platelet compositions and related methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,214,093 B2 - Document ID: US12214093B2 - Status: Granted - Kind: B2 - Application number: 16/227,094 - Filed: 2018-12-20 - Published: 2019-09-05 - Granted: 2025-02-04 - Earliest claimed: 2017-12-20 - Assignees: Sexton Biotechnologies, Inc. - Applicants: Sexton Biotechnologies, Inc. - Inventors: Steven Charlebois; Sreedhar Thirumala - Web page: https://patentgrep.com/patent/US12214093B2 ## CPC - A61L 2/087: Particle radiation, e.g. electron-beam, alpha or beta radiation - A61K 35/19: Platelets; Megacaryocytes - A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells - A61P 37/00: Drugs for immunological or allergic disorders - C12N 5/0644: {Platelets; Megakaryocytes} - C12N 5/0662: {Stem cells} - A61L 2103/05: Living organisms or biological materials - A61L 2103/09: Blood or products thereof - C12N 2500/84: from mammals - C12N 2501/11: Epidermal growth factor [EGF] - C12N 2501/115: Basic fibroblast growth factor (bFGF, FGF-2) - C12N 2501/135: Platelet-derived growth factor [PDGF] - C12N 2501/15: Transforming growth factor beta (TGF-β) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) ## Abstract Disclosed are methods for treating platelet compositions (e.g. platelet concentrates and/or platelet lysates) with electron beam radiation, where the compositions are in a frozen state during irradiation with the e-beam radiation. The methods can be conducted using e-beam radiation at doses effective to reduce the pathogen content of the compositions while retaining highly beneficial bioactivities of the compositions. Also disclosed are compositions preparable by the methods, and methods and compositions involving the use of the e-beam treated materials. ## Claims ### Claim 1 A method for making a pathogen reduced platelet composition, comprising: irradiating a frozen composition comprising a platelet lysate with electron beam radiation having an energy level of 5 MeV to 15 MeV, wherein the irradiating is conducted to apply 60 kGy to 100 kGy of electron beam radiation to the frozen composition, wherein the electron beam radiation is applied to a first side of the frozen composition and to a second side of the frozen composition opposite the first side, and wherein a thickness of the frozen composition between the first side and the second side is 0.5-5 cm. ### Claim 2 (depends on 1) The method of claim 1, wherein during said irradiating the frozen composition is contained within a container, and wherein the electron beam radiation penetrates through the container and into the frozen composition. ### Claim 3 (depends on 1) The method of claim 1, also comprising applying cooling to the frozen composition during the irradiating. ### Claim 4 (depends on 1) The method of claim 1, wherein the irradiating comprises irradiating the frozen composition with electron beam radiation at a dose effective to achieve a reduction in a level of at least one virus in the composition. ### Claim 5 (depends on 4) The method of claim 4, wherein the reduction is at least a 3-Log reduction. ### Claim 6 (depends on 5) The method of claim 5, wherein the virus is a Bovine Viral Diarrhea Virus. ### Claim 7 (depends on 1) The method of claim 1, wherein the irradiating is conducted so as to provide a max/min radiation dose ratio of 1:5 or lower, wherein the max/min dose ratio is a ratio of a maximum dose received by any portion of the frozen composition to a minimum dose received by any portion of the frozen composition. ### Claim 8 (depends on 1) The method of claim 1, including, prior to said irradiating, conforming a deformable container containing the composition in liquid form to a first shape and freezing the composition with said container in said first shape to provide said frozen composition. ### Claim 9 (depends on 1) The method of claim 1, also comprising, after said irradiating, thawing the frozen composition to form a liquid composition. ### Claim 10 (depends on 9) The method of claim 9, also comprising, after said thawing, transferring the liquid composition to one container or to multiple containers in a sterile transfer operation.