Bulk freezing of biopharmaceuticals

Abstract

A system and method for bulk freezing is provided. In one embodiment, the system and method for bulk freezing includes a bulk freezing container adapted to hold at least one and preferably a plurality of bags holding a biopharmaceutical liquid. The bulk freezing container includes at least a first and second shelf having corrugations wherein the second shelf is vertically arranged above the first shelf with the bags disposed between the shelves. The bags and the corrugations of the first and second shelves define a plurality of substantially parallel flow channels through which a cryogenic cold fluid or a warming fluid is passed to freeze and/or thaw the biopharmaceutical fluid. In another embodiment, the bulk freezing system and method includes a bulk freezing container with a plurality of adjacent elongated chambers adapted for holding the biopharmaceutical fluid. The adjacent elongated chambers have side walls defining a plurality of substantially parallel flow channels between the plurality of adjacent elongated chambers through which a heat transfer medium is passed for heat exchange through the side walls of the elongated chambers to the fluid within the elongated chambers.

1 . A bulk freezing system comprising:
 a bulk freezing container having a first shelf and a second shelf each s corrugations, wherein said second shelf is arranged above said first shelf;   a support platform arranged to support said bulk freezing container; and   at least one bag adapted for holding a fluid and disposed between said first shelf and said second shelf, wherein said bag and said corrugations of said first and second shelf define a plurality of substantially parallel flow channels.   
     
     
         2 . A bulk freezing system comprising:
 a bulk freezing container having an upper structure comprising at least two adjacent elongated chambers adapted for holding a fluid, wherein said at least two adjacent elongated chambers have side walls, and a plurality of substantially parallel flow channels located between said at least two adjacent elongated chambers for heat exchange through said side walls of said at least two adjacent elongated chambers; and   a support platform adapted to support said bulk freezing container.   
     
     
         3 . The system of  claim 1 , further comprising a source of cryogenic cold fluid arranged to provide cryogenic cold fluid to said plurality of said flow channels within said bulk freezing container. 
     
     
         4 . The system of  claim 3 , wherein said source of cryogenic cold fluid provides a substantially uniform temperature and flow of cryogenic cold fluid to each bag or to said side walls of said elongated chambers within said bulk freezing container. 
     
     
         5 . The system of  claim 3 , wherein said bulk freezing container is moveably disposed in a bulk freezing chamber and said source of cryogenic cold fluid is delivered to said bulk freezing container within said bulk freezing chamber. 
     
     
         6 . The system of  claim 1 , further comprising a source of warming fluid arranged to provide warming fluid to said plurality of said flow channels within said bulk freezing container and wherein said source of warming fluid provides a substantially uniform temperature and flow of warming fluid to each bag or to said side walls of said elongated chambers within said bulk freezing container, 
     
     
         7 . The system of  claim 1 , wherein said fluid is a liquid and comprises biopharmaceuticals, microorganisms, live cells, stem cells, primary cells, cell lines, small multicellular organisms, complex cellular structures, live or attenuated viruses, nucleic acids, monoclonal antibodies, polyclonal antibodies, biomolecules, nonpeptide analogues, peptides, proteins, RNA, DNA, oligonucleotides, and/or viral particles. 
     
     
         8 . The system of  claim 1 , wherein said support platform includes rollers arranged to moveably dispose said bulk freezing container to one or more prescribed locations including a bulk freezing chamber, a cold storage location, a fluid filling station, or a shipment location. 
     
     
         9 . The system of  claim 1 , wherein said bulk freezing container further comprises a plurality of support rods arranged to support a set (no antecedent basis for set) of said first and second shelf and wherein said plurality of support rods are substantially horizontally arranged in said plurality of substantially parallel flow channels. 
     
     
         10 . The system of  claim 1 , wherein said at least one bag is configured to be filled or emptied while disposed between said first and second shelf. 
     
     
         11 . The system of  claim 1 , further comprising a plurality of bags disposed between said first and second shelf and wherein said bags are arranged to be simultaneously filled or emptied. 
     
     
         12 . The system of  claim 1 , wherein said corrugations of said first and second shelf define flow channels for a plurality of bags disposed above and below each of a set of said first and second shelf. 
     
     
         13 . A method for freezing and/or thawing a fluid in a bag comprising the steps of:
 providing a bulk freezing container comprising a first shelf and a second shelf each having corrugations;   providing a support platform arranged to support said first and second shelf providing at least one bag adapted for holding a fluid horizontally disposed between said first and second shelf, wherein at least one bag and said corrugations of said first and second shelf define a plurality of substantially parallel flow channels;   filling said at least one bag with said fluid; and   flowing a heat exchange medium through said plurality of flow channels to transfer heat with respect to said fluid in said at least one bag to freeze or thaw said fluid in said at least one bag.   
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 13 , wherein said method is a method for freezing said fluid and wherein said heat exchange medium is a cryogenic cold fluid. 
     
     
         16 . The method of  claim 13 , wherein said method is a method for warming said fluid and wherein said heat exchange medium is water. 
     
     
         17 . The method of  claim 13 , wherein the step of flowing the heat exchange medium through said flow channel(s) further comprises providing a substantially uniform temperature and flow of heat exchange medium via said flow channel(s) to each bag or side wall of said elongated chambers. 
     
     
         18 . The method of  claim 13 , wherein said fluid is a liquid and comprises biopharmaceuticals, microorganisms, live cells, stem cells, primary cells, cell lines, small multicellular organisms, complex cellular structures, live or attenuated viruses, nucleic acids, monoclonal antibodies, polyclonal antibodies, biomolecules, nonpeptide analogues, peptides, proteins, RNA, DNA, oligonucleotides, and/or viral particles. 
     
     
         19 . The method of  claim 13 , wherein said support platform includes rollers arranged to moveably dispose the bulk freezing container to one or more prescribed locations including a bulk freezing chamber, a cold storage location, a fluid filling station, or a shipment location. 
     
     
         20 . (canceled)