Kits and methods for preparing pathogen-inactivated platelet compositions
Provided are methods for preparing pathogen-inactivated platelet compositions, as well as processing sets and compositions related thereto.
1. A method of preparing a pathogen-inactivated platelet composition, comprising:
(a) mixing a platelet composition with a pathogen inactivation compound (PIC), wherein the PIC is a psoralen, and wherein the platelet composition has a volume of about 250 mL to about 750 mL;
(b) photochemically inactivating the platelet composition in admixture with the PIC; and
(c) transferring the resultant mixture of step (b) under sterile conditions to a container containing a compound adsorption device (CAD) to produce a pathogen-inactivated platelet composition;
wherein at least one of (i) and (ii) applies:
(i) the volume of the container containing the CAD is about 1.2 L to about 1.6 L; and
(ii) the surface area of the interior of the container containing the CAD is about 800 cm 2 to about 1200 cm 2 .
2. The method of claim 1 , further comprising:
(d) transferring the pathogen-inactivated platelet composition under sterile conditions from the container containing the CAD to one or more storage containers.
3. The method of claim 2 , wherein the one or more storage containers is two storage containers.
4. The method of claim 2 , wherein the one or more storage containers is three storage containers.
5. The method of claim 1 , wherein the volume of the container containing the CAD is about 1.2 L to about 1.6 L.
6. The method of claim 1 , wherein the surface area of the interior of the container containing the CAD is about 800 cm 2 to about 1200 cm 2 .
7. The method of claim 1 , wherein the platelet composition comprises at least about 6.0×10 11 platelets.
8. The method of claim 1 , wherein the method comprises, prior to step (a), collecting one or more platelet donations from one or more donors.
9. The method of claim 1 , wherein the CAD comprises at least about three grams of adsorbent beads.
10. The method of claim 9 , wherein the CAD comprises less than about seven grams of adsorbent beads.
11. The method of claim 1 , wherein the CAD comprises at least about seven grams of adsorbent beads.
12. The method of claim 2 , further comprising, after step (d), storing the pathogen-inactivated platelet composition in the one or more storage containers for at least 5 days at room temperature.
13. The method of claim 12 , wherein the storage is for up to 7 days at room temperature.
14. The method of claim 12 , wherein the pH of the pathogen-inactivated platelet composition after storage is ≥6.2.
15. The method of claim 1 , wherein the pathogen-inactivated platelet composition is one or more pathogen-inactivated platelet units suitable for infusion.
16. The method of claim 1 , wherein the platelet composition comprises about 6.0×10 11 to about 12.0×10 11 platelets.
17. The method of claim 1 , wherein the platelet composition comprises plasma.
18. The method of claim 1 , wherein the platelet composition comprises platelet additive solution.
19. The method of claim 12 , wherein the pH of the pathogen-inactivated platelet composition after storage is ≥6.4.
20. The method of claim 15 , wherein the pathogen-inactivated platelet unit suitable for infusion is a therapeutic dosage unit of pathogen-inactivated platelets.
21. The method of claim 15 , wherein the pathogen-inactivated platelet unit suitable for infusion comprises at least 2.0×10 11 platelets.
22. The method of claim 1 , wherein the platelet composition comprises at least 3.0×10 11 platelets.
23. The method of claim 3 , wherein the platelet composition comprises less than about 8.0×10 11 platelets.
24. The method of claim 4 , wherein the platelet composition comprises less than about 12.0×10 11 platelets.
25. The method of claim 1 , wherein the platelet composition has a volume of about 250 mL to about 650 mL.
26. A method of preparing a pathogen-inactivated platelet composition, comprising:
(a) mixing a platelet composition with a pathogen inactivation compound (PIC), wherein the PIC is a psoralen, and wherein the platelet composition has a volume of about 250 mL to about 750 mL;
(b) photochemically inactivating the platelet composition in admixture with the PIC;
(c) transferring the resultant mixture of step (b) under sterile conditions to a container containing a compound adsorption device (CAD) to produce a pathogen-inactivated platelet composition;
wherein the CAD comprises less than about seven grams of adsorbent beads, and at least one of (i) and (ii) applies:
(i) the volume of the container containing the CAD is about 1.2 to about 1.6 L; and
(ii) the surface area of the interior of the container containing the CAD is about 800 cm 2 to about 1200 cm 2 ; and
(d) transferring the pathogen-inactivated platelet composition under sterile conditions from the container containing the CAD to two storage containers,
wherein the pathogen-inactivated platelet composition in each of said two storage containers is a therapeutic dosage unit of pathogen-inactivated platelets suitable for infusion.
27. The method of claim 26 , wherein the platelet composition has a volume of about 250 mL to about 650 mL.
28. A method of preparing a pathogen-inactivated platelet composition, comprising:
(a) mixing a platelet composition with a pathogen inactivation compound (PIC), wherein the PIC is a psoralen, and wherein the platelet composition has a volume of about 250 mL to about 750 mL;
(b) photochemically inactivating the platelet composition in admixture with the PIC;
(c) transferring the resultant mixture of step (b) under sterile conditions to a container containing a compound adsorption device (CAD) to produce a pathogen-inactivated platelet composition;
wherein the CAD comprises at least about seven grams of adsorbent beads, and at least one of (i) and (ii) applies:
(i) the volume of the container containing the CAD is about 1.2 to about 1.6 L; and
(ii) the surface area of the interior of the container containing the CAD is about 800 cm 2 to about 1200 cm 2 ; and
(d) transferring the pathogen-inactivated platelet composition under sterile conditions from the container containing the CAD to three storage containers,
wherein the pathogen-inactivated platelet composition in each of said three storage containers is a therapeutic dosage unit of pathogen-inactivated platelets suitable for infusion.
29. The method of claim 28 , wherein the platelet composition has a volume of about 250 mL to about 650 mL.