Systems and methods for freezing, storing and thawing biopharmaceutical material

Abstract

A system for controlled freezing, storing and thawing a biopharmaceutical material includes a flexible container and a supporting structure. The flexible container is adapted to receive the biopharmaceutical material therein for freezing, storing and thawing. The container further includes a flange and the supporting structure is engageable with the flange to receive the container. The supporting structure may position the container for freezing and may protect it during transport and storage.

1 . A system for freezing, storing and thawing a biopharmaceutical material, said system comprising: 
 a container means for receiving biopharmaceutical materials therein;    a support member forming a cavity configured to receive said container means therein and to support a weight of said container means when said container means holds biopharmaceutical materials; and    said cavity bounded by inner surfaces of said support member facing each other and by covering portions releasably engaged with said support member, said covering portions located opposite each other about said cavity and configured to allow flattening of said container means within said cavity.    
     
     
         2 . The system of  claim 1  wherein said covering portions are connected to each other by a connecting member.  
     
     
         3 . The system of  claim 2  wherein said covering portions are aligned substantially parallel to each other and said connecting member is aligned substantially perpendicular to said covering portions.  
     
     
         4 . The system of  claim 1  wherein opposite ends of a first covering portion of said covering portions are spaced from opposite ends of a second covering portion of said covering portions.  
     
     
         5 . The system of  claim 1  wherein said support member comprises feet allowing said support member to stand independently.  
     
     
         6 . The system of  claim 1  wherein said container means contains biopharmaceutical materials and said container means abuts said covering portions.  
     
     
         7 . The system of  claim 1  wherein said container means contains biopharmaceutical materials and said container means contacts said inner surfaces and said covering portions to substantially inhibit space between said container means and said inner surfaces and said covering portions.  
     
     
         8 . The system of  claim 1  wherein said container means is connected to said support member such that said container means is suspended from said support member in said cavity.  
     
     
         9 . The system of  claim 8  wherein said container means is suspended such that a height of said container means is substantially aligned with a height of said support member.  
     
     
         10 . The system of  claim 8  wherein said container means comprises a flange connected to said support member, said flange configured to support said weight of said container material when said flange is connected to said support member and said container means holds said biopharmaceutical materials.  
     
     
         11 . The system of  claim 1  wherein said container means is flexible in response to receiving the biopharmaceutical materials.  
     
     
         12 . A system for freezing, storing and thawing a biopharmaceutical material, said system comprising: 
 a container means for receiving biopharmaceutical materials therein;    a support member forming a cavity configured to receive said container means therein and to support a weight of said container means when said container means holds biopharmaceutical materials;    said cavity bounded by inner surfaces of said support member facing each other and by covering portions located opposite each other about said cavity; and    means for flattening said container means within said cavity.    
     
     
         13 . The system of  claim 12  wherein said covering portions are connected to each other by a connecting member.  
     
     
         14 . The system of  claim 13  wherein said covering portions are aligned substantially parallel to each other and said connecting member is aligned substantially perpendicular to said covering portions.  
     
     
         15 . The system of  claim 12  wherein opposite ends of a first covering portion of said covering portions are spaced from opposite ends of a second covering portion of said covering portions.  
     
     
         16 . The system of  claim 12  wherein said support member comprises feet configured to allow said support member to stand independently.  
     
     
         17 . The system of  claim 12  wherein said container means contains biopharmaceutical materials and said container means abuts said covering portions.  
     
     
         18 . The system of  claim 12  wherein said container means contains biopharmaceutical materials and said container means contacts said inner surfaces and said covering portions to substantially inhibit space between said container means and said inner surfaces and said covering portions.  
     
     
         19 . The system of  claim 12  wherein said container means is connected to said support member such that said container means is suspended from said support member in said cavity.  
     
     
         20 . The system of  claim 19  wherein said container means is suspended such that a height of said container means is substantially aligned with a height of said support member.  
     
     
         21 . The system of  claim 19  wherein said container means comprises a flange connected to said support member, said flange configured to support said weight of said container material when said flange is connected to said support member and said container means holds said biopharmaceutical materials.  
     
     
         22 . The system of  claim 12  wherein said container means is flexible in response to receiving the biopharmaceutical materials.  
     
     
         23 . A method for freezing, storing and thawing biopharmaceutical material, the method comprising: 
 providing a container means for receiving biopharmaceutical materials therein;    receiving the container means in a cavity of a support member and supporting a weight of the container means by the support member when the container means holds biopharmaceutical materials;    the cavity bounded by inner surfaces of the support member facing each other;    releasably engaging covering portions with the support member such that the covering portions are located opposite each other about the cavity; and    flattening the container means between the covering portions and within the cavity.    
     
     
         24 . The method of  claim 23  further comprising connecting the covering portions to each other by a connecting member.  
     
     
         25 . The method of  claim 24  wherein the covering portions are aligned substantially parallel to each other and the connecting member is aligned substantially perpendicular to the covering portions.  
     
     
         26 . The method of  claim 23  wherein opposite ends of a first covering portion of the covering portions are spaced from opposite ends of a second covering portion of the covering portions.  
     
     
         27 . The method of  claim 23  further comprising standing the support member independently on feet of the support member.  
     
     
         28 . The method of  claim 23  further comprising receiving biopharmaceutical materials in the container means, freezing the biopharmaceutical materials and maintaining the frozen biopharmaceutical materials entirely within the cavity.  
     
     
         29 . The method of  claim 23  further comprising receiving biopharmaceutical materials in the container means and abutting the container means with the covering portions.  
     
     
         30 . The method of  claim 23  receiving biopharmaceutical materials in the container means and abutting the container means with the inner surfaces and said covering portions to substantially inhibit space between the container means and the inner surfaces and the covering portions.  
     
     
         31 . The method of  claim 23  wherein the container means is connected to the support member such that the container means is suspended from the support member in the cavity.  
     
     
         32 . The method of  claim 31  wherein the container means is suspended such that a height of the container means is substantially aligned with a height of the support member.  
     
     
         33 . The method of  claim 31  wherein the container means comprises a flange connected to the support member, the flange configured to support the weight of the container material when the flange is connected to the support member and the container means holds the biopharmaceutical materials.  
     
     
         34 . The method of  claim 23  wherein the container means is flexible in response to receiving the biopharmaceutical materials.