Methods for handling biological drugs containing living cells

Abstract

The present invention includes methods for handling live cell compositions in non-nutritive buffer. The cells in the compositions maintain their identity and functional characteristics after being stored in non-nutritive media up to about 72 hours. The storage method enables the cells to be manufactured at a processing facility and shipped to a point of care site. The invention also includes compositions that have been stored in non-nutritive buffer at storage temperatures while maintaining the functional characteristics.

What is claimed is: 
     
         1 . A method of administering immunotherapy to a patient comprising administering a composition comprising living cells formulated in non-nutritive buffer, wherein the composition has been stored for greater than about six hours in the non-nutritive buffer, wherein the living cells maintain their identity and at least one of the functional characteristics of the cells that defined the living cells prior to formulation in the non-nutritive buffer, the living cells useful in immunotherapy. 
     
     
         2 . The method of  claim 1  wherein the live cells are activated Th1 cells. 
     
     
         3 . The method of  claim 1  wherein the functional characteristic is expression of CD40L, FasL, perforin and granzyme B, expression of costimulatory molecules, expression of adhesion molecules, secretion of cytokines, chemokines or combinations thereof. 
     
     
         4 . The method of  claim 1  wherein the live cells in the composition express CD40L after storage in an amount of at least about 80% relative to the expression of CD40L at the time of formulation. 
     
     
         5 . The method of  claim 1  wherein the cells in the composition secrete IFN-γ after storage in an amount of at least about 80% compared to the levels at the time of formulation 
     
     
         6 . The method of  claim 1  wherein the live cells in the non-nutritive buffer are stored for at least about 72 hours. 
     
     
         7 . The method of  claim 1  wherein the composition has a cell viability of at least about 80% after storage. 
     
     
         8 . The method of  claim 5  wherein the secretion of IFN-γ after storage is recovered after incubation at 37° C. for at least 24 hours. 
     
     
         9 . The method of  claim 4  wherein the live cells in the non-nutritive buffer are stored for at least about 24 hours. 
     
     
         10 . The method of  claim 4  wherein the live cells in the non-nutritive buffer are stored for at least about 48 hours.