JP-2022532262-A5 -

Dates

Publication Date

20230512

Application Date

20200501

Description

The materials and methods described herein can offer several advantages. Firstly, they can enable the collection of donors that would otherwise be omitted, thereby reducing competition for apheresis materials. [Invention 1001] A process for preparing a composition comprising platelets or platelet derivatives and an aqueous medium, comprising preparing a composition comprising platelets or platelet derivatives and an aqueous medium by tangential flow filtration (TFF) of a starting material comprising platelets, a diluted starting material comprising platelets, a concentrated platelet composition, or a combination thereof, The aqueous medium has a protein concentration of 50% or less of the protein concentration of donor apheresis plasma. process. [Invention 1002] The process of the present invention 1001, further comprising a pathogen reduction step. [Invention 1003] The process of the present invention 1002, wherein the pathogen reduction step precedes TFF. [Invention 1004] A process according to any one of the present invention 1001 to 1003, wherein the starting material has a protein concentration of about 60 to about 80 mg/mL. [Invention 1005] A process according to any one of the present invention 1001 to 1004, wherein the TFF includes diafiltering in at least two diavolutes. [Invention 1006] A process according to any one of the present invention 1001 to 1005, wherein the TFF includes diafiltration using a preparation comprising a buffer, a base, a packing agent, optionally a salt, and optionally at least one organic solvent. [Invention 1007] A process according to any one of the present invention 1001 to 1006, wherein the TFF comprises buffer exchange to a preparation comprising a buffer, a base, a packing agent, optionally a salt, and optionally at least one organic solvent. [Invention 1008] The process according to any one of the present invention 1006 to 1007, wherein the preparation comprises a buffer containing HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid), a base containing sodium bicarbonate, and a filler containing trehalose, polysucrose, or a combination thereof. [Invention 1009] The process according to any one of the present invention 1006 to 1008, wherein the preparation agent comprises an organic solvent including ethanol, DMSO, or a combination thereof. [Invention 1010] A process according to any one of the present invention 1001 to 1009, wherein the protein concentration of the aqueous medium is 30% or less of the protein concentration of the donor apheresis plasma. [Invention 1011] A process according to any one of the present invention 1001 to 1010, wherein the protein concentration of the aqueous medium is 10% or less of the protein concentration of the donor apheresis plasma. [Invention 1012] A process according to any one of the present invention 1001 to 1010, wherein the protein concentration of the aqueous medium is about 5% to about 15% of the protein concentration of the donor apheresis plasma. [Invention 1013] The process according to any one of the present invention 1001 to 1012, wherein the protein concentration of the aqueous medium is about 7% to about 10% of the protein concentration of the donor apheresis plasma. [Invention 1014] A process according to any one of the present invention 1001 to 1013, wherein the composition contains less than 5.0% fine particles (based on scattering intensity). [Invention 1015] A process according to any one of the present invention 1001 to 1013, wherein the composition contains less than 4.0% fine particles (based on scattering intensity). [Invention 1016] A process according to any one of the present invention 1001 to 1015, further comprising freeze-drying and/or cryopreserving the composition comprising platelets or platelet derivatives. [Invention 1017] A process according to any one of the present invention 1001 to 1016, further comprising thermally treating the composition comprising platelets or platelet derivatives. [Invention 1018] The process according to any one of the present invention 1001 to 1017, wherein the platelet or platelet derivative has at least 55% CD41 positivity. [Invention 1019] A process according to any one of the present invention 1001 to 1018, wherein the platelet or platelet derivative has at least 80% CD42 positive percentage. [Invention 1020] A process according to any one of the present invention 1001 to 1019, wherein the platelet or platelet derivative has at least 70% annexin V positive percentage. [Invention 1021] The process according to any one of the present invention 1001 to 1020, wherein the platelet or platelet derivative has at least 8% CD47 positivity. [Invention 1022] A process according to any one of the present invention 1001 to 1021, wherein the platelet or platelet derivative has at least 80% CD62 positive percentage. [Invention 1023] The process according to any one of the present invention 1001 to 1022, wherein the platelet or platelet derivative has fibrinogen associated wit