US2021322479A1PendingUtilityA1

Methods for preparing platelet products

Assignee: CERUS CORPPriority: Jul 23, 2014Filed: Nov 23, 2020Published: Oct 21, 2021
Est. expiryJul 23, 2034(~8 yrs left)· nominal 20-yr term from priority
C12N 5/0644A61K 35/19
58
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Claims

Abstract

Provided herein are improved processes for preparing and treating platelet products. The methods are useful in the efficient preparation of platelet products with desirable characteristics, including pathogen inactivated platelet products.

Claims

exact text as granted — not AI-modified
1 - 163 . (canceled) 
     
     
         164 . A method of preparing a pooled platelet product, comprising:
 a) selecting a subset of whole blood units from a plurality of donated whole blood units;   b) centrifuging the selected subset of units under the same centrifugation conditions to provide each unit having a separated layer of platelet rich plasma;   c) isolating the separated layer of platelet rich plasma to provide a platelet rich plasma unit;   d) centrifuging the isolated platelet rich plasma unit to provide a platelet rich plasma unit having separated layers of platelet poor plasma and platelet concentrate;   e) isolating the separated layer of platelet concentrate to provide a platelet concentrate unit from the subset of whole blood units;   f) pooling at least seven isolated platelet concentrate units into one container to provide a pooled platelet product;   g) treating the pooled platelet product with a pathogen inactivation compound to inactivate pathogens, if present; and   h) transferring the pooled platelet product into two storage containers to provide a double dose pooled platelet product.   
     
     
         165 . The method of  claim 164 , comprising pooling 7-12 isolated platelet concentrate units. 
     
     
         166 . The method of  claim 165 , comprising pooling 7-10 isolated platelet concentrate units. 
     
     
         167 . The method of  claim 164 , wherein the pooled platelet product comprises at least about 6.0×10 11  platelets. 
     
     
         168 . The method of  claim 164 , where the double dose pooled platelet product comprises at least about 2×10 11  platelets per storage container. 
     
     
         169 . The method of  claim 168 , where the double dose pooled platelet product comprises at least about 3×10 11  platelets per storage container. 
     
     
         170 . The method of  claim 164 , wherein the isolated platelet concentrate further comprises donor plasma. 
     
     
         171 . The method of  claim 170 , wherein the donor plasma is plasma from the same donor as the isolated platelet concentrate. 
     
     
         172 . The method of  claim 170 , wherein the donor plasma is plasma from a different donor than the donor of the isolated platelet concentrate. 
     
     
         173 . The method of  claim 164 , further comprising adding an additive solution to the isolated platelet concentrate or the pooled platelet product. 
     
     
         174 . The method of  claim 164 , wherein the isolated platelet concentrate or the pooled platelet product comprises about 5 to 50% plasma and about 95 to 50% additive solution. 
     
     
         175 . The method of  claim 174 , wherein the isolated platelet concentrate or the pooled platelet product comprises about 30-50% plasma. 
     
     
         176 . The method of  claim 164 , wherein the isolated platelet concentrate has a volume of about 45-80 mL. 
     
     
         177 . The method of  claim 164 , wherein the isolated platelet concentrate has a volume of about 15-45 mL. 
     
     
         178 . The method of  claim 164 , wherein the isolated platelet concentrate has a volume of less than about 5 mL. 
     
     
         179 . The method of  claim 164 , wherein the pathogen inactivation compound is a photoactive pathogen inactivation compound selected from the group consisting of a psoralen, an isoalloxazine, an alloxazine, a phthalocyanine, a phenothiazine, a porphyrin, and merocyanine 540. 
     
     
         180 . The method of  claim 179 , wherein the pathogen inactivation compound is a psoralen. 
     
     
         181 . The method of  claim 180 , wherein the pathogen inactivation compound is amotosalen. 
     
     
         182 . The method of  claim 164 , further comprising a leukoreduction step. 
     
     
         183 . The method of  claim 182 , wherein the leukoreduction step is a filtration step. 
     
     
         184 . The method of  claim 164 , wherein the method is performed at least 2 hours after collection of the donated whole blood units. 
     
     
         185 . The method of  claim 164 , wherein the method is performed less than 24 hours after collection of the donated whole blood units. 
     
     
         186 . The method of  claim 164 , wherein the method is performed more than 8 hours and less than 24 hours after collection of the donated whole blood units. 
     
     
         187 . The method of  claim 164 , wherein the method is performed after an overnight storage of the donated whole blood units.

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