Aseptic bioprocess package

Abstract

An aseptic bioprocess package is provided herein. The aseptic bioprocess package includes a 2D flexible container including an interior compartment, a height having an upper half and a lower half, an inlet and an outlet, the inlet and the outlet being disposed on the same half of the 2D flexible container and a channel-forming feature in the interior compartment of the container, the channel-forming feature being configured to maintain a fluid flow path that fluidly connects the interior compartment of the flexible container with the outlet.

1 . An aseptic bioprocess package comprising:
 a 2D flexible container comprising an interior compartment, a height having an upper half and a lower half, an inlet and an outlet, the inlet and the outlet being disposed on the same half of the 2D flexible container; and   a channel-forming feature in the interior compartment of the container, the channel-forming feature being configured to maintain a fluid flow path that fluidly connects the interior compartment of the flexible container with the outlet.   
     
     
         2 . The aseptic bioprocess package of  claim 1 , wherein the 2D flexible container comprises two sheets hermetically sealed along edges of the two sheets to form the interior compartment. 
     
     
         3 . The aseptic bioprocess package of  claim 2 , wherein the two sheets comprise a film or laminate comprising a polymeric material selected from a group consisting of polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyethylene terephtalate (PET), polystyrene (PS), polycarbonate (PC), polymethylpentene (PMP), polyetheretherketone (PEEK) polytetrafluoroethylene (PTFE), polyfluoroalkoxy (PFA), polychlorotrifluoroethylene (PCTFE), ethylene vinyl acetate (EVA), and derivatives thereof. 
     
     
         4 . The aseptic bioprocess package of  claim 1 , wherein the inlet and the outlet comprise connectors having an internal fluid passage that permits the flow of fluids and/or other components into or out of the interior compartment of the flexible container. 
     
     
         5 . The aseptic bioprocess package of  claim 4 , wherein the connectors comprise rigid plastic. 
     
     
         6 . The aseptic bioprocess package of  claim 4 , wherein the connectors comprise flexible plastic tubing. 
     
     
         7 . The aseptic bioprocess package of  claim 1 , wherein the connectors comprise a face port. 
     
     
         8 . The aseptic bioprocess package of  claim 1 , comprising a port fitment having at least two ports, wherein one of the at least two ports is the inlet and another of the at least two ports is the outlet. 
     
     
         9 . The aseptic bioprocess package of  claim 1 , wherein the channel-forming feature comprises a solid extruded plastic component. 
     
     
         10 . The aseptic bioprocess package of  claim 9 , wherein the solid extruded plastic component is welded into a seam of the flexible container. 
     
     
         11 . The aseptic bioprocess package of  claim 9  comprising a plurality of connectors, wherein a first of the plurality of connectors is the inlet, a second of the plurality of connectors is the outlet and the solid extruded plastic component is disposed within a third of the plurality of connectors. 
     
     
         12 . The aseptic bioprocess package of  claim 9  comprising a port fitment having at least two ports, wherein a first of the at least two ports is the inlet, a second of the at least two ports is the outlet, and the solid extruded plastic component is disposed in a third of the plurality of ports. 
     
     
         13 . The aseptic bioprocess package of  claim 1 , wherein the channel-forming feature comprises a tubular plastic component. 
     
     
         14 . The aseptic bioprocess package of  claim 13 , wherein the tubular plastic component is welded into a seam of the flexible container. 
     
     
         15 . The aseptic bioprocess package of  claim 13  further comprising at least two inwardly facing face ports, wherein a first end of the tubular plastic component is attached to one of the at least two inwardly facing face ports and a second end of the tubular plastic component is attached to another of the at least two inwardly facing face ports. 
     
     
         16 . The aseptic bioprocess package of  claim 13  comprising a plurality of connectors, wherein a first of the plurality of connectors is the inlet, a second of the plurality of connectors is the outlet and the tubular plastic component is disposed within a third of the plurality of connectors. 
     
     
         17 . The aseptic bioprocess package of  claim 13  comprising a port fitment having at least two ports, wherein a first of the at least two ports is the inlet, a second of the at least two ports is the outlet, and the tubular plastic component is disposed in a third of the plurality of ports. 
     
     
         18 . The aseptic bioprocess package of  claim 1 , wherein the channel-forming feature comprises a raised portion which extends from an interior face of at least one of the two sheets. 
     
     
         19 . The aseptic bioprocess package of  claim 18 , wherein the raised portion comprises a plastic component attached to the interior face of the at least one of the two sheets. 
     
     
         20 . The aseptic bioprocess package of  claim 18 , wherein the raised portion comprises a textured portion of the interior face of the at least one of the two sheets. 
     
     
         21 . The aseptic bioprocess package of  claim 1 , further comprising a channel-forming feature extender having an opening disposed between a lower extension and an upper extension. 
     
     
         22 . The aseptic bioprocess package of  claim 21 , wherein the upper extension comprises an interior channel fluidly connecting the opening to the outlet. 
     
     
         23 . The aseptic bioprocess package of  claim 21 , further comprising a side extension comprising an interior channel fluidly connecting the opening to the interior channel of the upper extension. 
     
     
         24 . The aseptic bioprocess package of  claim 23 , wherein the angle between the side extension and the upper extension is about 90 degrees. 
     
     
         25 . The aseptic bioprocess package of  claim 23 , wherein the angle between the side extension and the upper extension is greater than about 90 degrees. 
     
     
         26 . The aseptic bioprocess package of  claim 1 , further comprising at least one hanging hole in the top welded edge of the container and at least one hanging hole in the bottom welded edge of the container. 
     
     
         27 . The aseptic bioprocess package of  claim 1 , further comprising a sealable opening in a face of at least one of two sheets of the flexible container. 
     
     
         28 . The aseptic bioprocess package of  claim 27  wherein the sealable opening comprises a collar and a sealing cap. 
     
     
         29 . A method for processing dry microcarrier material in a microcarrier bioprocess package, the method comprising:
 filling a bioprocess package with dry microcarrier material, the bioprocess package comprising:
 a 2D flexible container comprising an interior compartment, a height having an upper half and a lower half, an inlet and an outlet, the inlet and the outlet being disposed on the same half of the 2D flexible container; and 
 a channel-forming feature in the interior compartment of the container, the channel-forming feature being configured to maintain a fluid flow path that fluidly connects the interior compartment of the flexible container with the outlet; 
   sterilizing the dry microcarrier material in the bioprocess package;   hydrating the dry microcarrier material in the bioprocess package to form a hydrated microcarrier material;   washing the hydrated microcarrier material in the bioprocess package; and   aseptically transferring the hydrated microcarrier material from the bioprocess package to a cell culture vessel.   
     
     
         30 . The method of  claim 29 , wherein filling a bioprocess package with dry microcarrier material comprises adding dry microcarrier material to the interior compartment of the bioprocess package. 
     
     
         31 . The method of  claim 29 , wherein hydrating the dry microcarrier material in the bioprocess package comprises adding a hydrating fluid to the bioprocess package to contact the dry microcarrier material with the hydrating fluid. 
     
     
         32 . The method of  claim 31 , wherein hydrating the dry microcarrier material in the bioprocess package further comprises forming at least two liquid phases having different densities and dispensing the less dense upper liquid phases from the bioprocess package. 
     
     
         33 . The method of  claim 29 , wherein washing the hydrated microcarrier material comprises adding fluid and/or other components to the bioprocess package to contact the hydrated microcarrier material with the fluid and/or other components. 
     
     
         34 . The method of  claim 33 , wherein washing the hydrated microcarrier material further comprises forming at least two liquid phases having different densities and dispensing the less dense upper liquid phases from the bioprocess package. 
     
     
         35 . The method of  claim 29 , wherein aseptically transferring the hydrated microcarrier material comprises inverting the bioprocess package such that the half of the bioprocess package comprising the inlet and the outlet is positioned at the bottom of the bioprocess package such that gravity facilitates removal of the hydrated microcarrier material from the bioprocess package. 
     
     
         36 . The method of  claim 29 , wherein aseptically transferring the hydrated microcarrier material comprises fluidly connecting the bioprocess package to the cell culture vessel through an aseptic connector.