Methods and systems for cryopreservation and resuspension of body fluids

Abstract

The disclosure provides for a container system and method for the cryopreservation and resuspension of a body fluid. The container system may include a cryopreservation container comprising the body fluid in a cryopreservation liquid, a resuspension container comprising a resuspension solution, a connection tube sterilely connecting the cryopreservation container and the resuspension container, and at least one shut-off element actively associated with the connection tube.

What is claimed is: 
     
         1 . A method of resuspending a cryopreserved body fluid comprising:
 thawing a frozen container system comprising:
 a cryopreservation container comprising the body fluid in a cryopreservation liquid; 
 a resuspension container comprising a resuspension solution; 
 a connection tube sterilely connecting the cryopreservation container and the resuspension container; and 
 at least one shut-off element actively associated with the connection tube, 
 wherein the shut-off element is closed such that the body fluid in a cryopreservation liquid and resuspension solution cannot mix; 
 opening the shut-off element; and 
 adding at least a portion of the resuspension solution to the cryopreservation container to create a resuspended body fluid product. 
   
     
     
         2 . The method of  claim 1 , further comprising resting for a period of up to 30 minutes at room temperature after thawing the frozen container system. 
     
     
         3 . The method of  claim 1 , wherein the body fluid is selected from platelets and blood. 
     
     
         4 . The method of  claim 3 , wherein the body fluid is cryopreserved platelets. 
     
     
         5 . The method of  claim 1 , further comprising transporting the resuspended body fluid product to a site for transfusion. 
     
     
         6 . The method of  claim 1 , wherein the resuspended body fluid product is shelf stable for more than 4 hours. 
     
     
         7 . The method of  claim 6 , wherein the resuspended body fluid product remains shelf stable for at least 24 hours. 
     
     
         8 . The method of  claim 1 , wherein the resuspension solution is a transfusable solution. 
     
     
         9 . The method of  claim 8 , wherein the transfusable solution is selected from sterile NaCl, human plasma, and a platelet storage solution. 
     
     
         10 . The method of  claim 1 , wherein the container system is a closed and sterile system. 
     
     
         11 . A closed and sterile container system comprising:
 a cryopreservation container comprising a body fluid in a cryopreservation liquid;   a sterile filter sterilely and fluidly connected to the cryopreservation container; and   a resuspension container comprising a resuspension solution configured to connect to the sterile filter, wherein the sterile filter is configured to filter the resuspension solution when the resuspension solution is added to the cryopreservation container,   wherein the body fluid comprises concentrated platelets.   
     
     
         12 . The container system of  claim 11 , wherein the sterile filter is integrated with the cryopreservation container such that the connection remains sterile throughout freezing and thawing . 
     
     
         13 . The container system of  claim 11 , wherein a body fluid product is created in the container system by thawing the cryopreservation container, connecting the resuspension container to the sterile filter, and adding at least a portion of the resuspension solution to the body fluid, creating a resuspended body fluid product. 
     
     
         14 . The container system of  claim 13 , wherein the resuspended body fluid product remains shelf stable for more than 4 hours. 
     
     
         15 . The container system of  claim 11 , wherein the resuspension solution is a transfusable solution. 
     
     
         16 . The container system of  claim 15 , wherein the transfusable solution is selected from sterile NaCl, human plasma, and platelet storage solution. 
     
     
         17 . A method of resuspending a cryopreserved body fluid comprising:
 providing a frozen container system of  claim 11 ;   thawing the container system;   connecting the resuspension container comprising the resuspension solution to the sterile filter; and   adding at least a portion of the resuspension solution to the cryopreservation container, via the sterile filter, to create a resuspended body fluid product.   
     
     
         18 . The method of  claim 17 , further comprising transporting the resuspended body fluid product to a site for transfusion.