Method and System for Transferring Separation Resin

Abstract

A method and a system and a container system for transferring separation resin from at least one first container (3; 3′; 3a, 3b; 3a′, 3b′, 3c′, 3d′) to a second container (5; 5′), wherein said first container is a deformable, single-use separation resin storage container, said method comprising the steps of:preparing (S1) the at least one first container by providing a deformable, single-use container comprising an outlet port (4′) with a predefined volume of separation resin in a storage solution;fluidizing (S3) the separation resin in the at least one first container to provide a resin slurry, said fluidizing being performed by mechanical interaction to the first container from an outside of the first container to provide a deformation of said first container;fluidically connecting (S5) the outlet port (4′) of the at least one first container to an inlet port (103) of the second container;transferring (S7) separation resin from the at least one first container to the second container by generating a pressure difference between an interior of the second container and an interior of the first container where the pressure is lower in the second container.

1 .- 17 . (canceled) 
     
     
         18 . A container system, wherein said container system comprises:
 at least one first container which is a deformable, single-use separation resin storage container comprising a predetermined volume of separation resin and a predetermined volume of storage solution, said first container further comprising an outlet port arranged for transferring the separation resin; and   a mechanical interaction device provided in connection with an outside of the first container such that it can provide a deformation to said first container.   
     
     
         19 . The container system according to  claim 18 , wherein said mechanical interaction device is provided in a storage bin in which said first container is provided. 
     
     
         20 . The container system according to  claim 19 , wherein said mechanical interaction device is one or more of at least one movable bottom or side part in the storage bin, at least one inflatable air cushion inside the storage bin and a tilting device for tilting the storage bin. 
     
     
         21 . The container system according to  claim 18 , wherein said at least one first container is a flexible bag. 
     
     
         22 . The container system according to  claim 18 , wherein said container system is configured for use in the packing of a column for manufacturing-scale separation of a biopharmaceutical. 
     
     
         23 . A system for transferring separation resin between at least two containers, wherein said system comprises:
 at least one container system according to  claim 18 , said container system comprising at least one first container;   a second container comprising an inlet port which is fluidically connected to the outlet port of said at least one first container; and   a pressure difference generating device configured for transferring separation resin from the at least one first container to the second container by generating a pressure difference between an interior of the second container and an interior of the first container where the pressure is lower in the second container.   
     
     
         24 . The system according to  claim 23 , wherein said second container is a separation device. 
     
     
         25 . The system according to  claim 23 , wherein said pressure difference generating device is an under-pressure generating device configured for transferring separation resin from the at least one first container to the second container by generating an under-pressure in the second container in relation to the pressure in the first container. 
     
     
         26 . The system according to  claim 23 , wherein the system comprises two or more first containers connected in series or in parallel and which are fluidically connected to the second container. 
     
     
         27 . The system according to  claim 26 , wherein the outlet ports of the two or more first containers are connected to a resin transfer manifold which in turn is connected to the inlet of the second container. 
     
     
         28 . The system according to  claim 23 , wherein the at least one first container comprising separation resin has been sterilized by gamma radiation and an interior of the second container has been sterilized before they are fluidically connected by aseptic connections. 
     
     
         29 . The system according to  claim 23 , wherein said said pressure difference pressure generating device is at least one under-pressure generating device/vacuum production device connected to the second container and arranged for providing a degree of vacuum/under-pressure in the second container at least during a transferring of the separation resin from the at least one first container to the second container and wherein the at least one first container is connected to the second container by a transferring connection such that the separation resin initially provided in the at least one first container can be transferred from the at least one first container to the second container through the transferring connection by the vacuum/under-pressure provided to the second container. 
     
     
         30 . The system according to  claim 29 , wherein the transferring connection comprises disposable pre-sterilized connecting parts. 
     
     
         31 . The system according to  claim 29 , wherein the transferring connection comprises at least one valve whereby opening of the at least one valve allows vacuum/under-pressure provided to the second container to affect the content in the first container such that the separation resin initially provided in the first container is transferred to the second container through the transferring connection. 
     
     
         32 . The system according to  claim 23 , wherein the system further comprises a rinse bag connected to the first container said rinse bag comprising a rinsing solution for rinsing the first container when the separation resin has been transferred to the second container, said rinsing solution being transferred from the rinse bag to the first container by the same pressure difference as generated between an interior of the second container and the first container for transferring the separation resin. 
     
     
         33 . The system according to  claim 32 , wherein a rinse valve is provided between the rinse bag and the at least one first container such that rinsing solution is transferred from the rinse bag to the at least one first container by the pressure difference generated between the first and second containers when the rinse valve is open. 
     
     
         34 . The system according to  claim 23 , wherein the second container is a chromatography column connected to a liquid supply system such that the separation resin can be fluidized within the second container by the liquid supply system. 
     
     
         35 . The system according to  claim 34 , wherein the second container comprises a liquid distribution system at an inlet for the liquid supply system hereby improving a homogenization of the slurry provided by the fluidization. 
     
     
         36 . The system according to  claim 23 , wherein the second container comprises an adaptor defining the internal volume of the second container together with a bottom and internal walls of the second container, which adaptor can be used as the pressure difference generating device by raising it within the second container thus increasing the internal volume of the second container. 
     
     
         37 . The system according to  claim 23 , wherein said at least one first container is a flexible bag. 
     
     
         38 . The system according to  claim 23 , wherein said system is configured for use in the packing of a column for manufacturing-scale separation of a biopharmaceutical. 
     
     
         39 . A method for aseptic packing of a chromatography column with a separation resin comprising the steps of:
 filling a predetermined volume of separation resin and a volume of storage solution in a first container, said first container being a deformable, single-use container comprising an outlet port;   sterilizing the first container comprising the separation resin by gamma radiation;   sterilizing an interior of a chromatography column, said chromatography column being a second container;   aseptically connecting the first container to the second container;   fluidizing the separation resin in the at least one first container to provide a resin slurry, said fluidizing being performed by mechanical interaction to the first container from an outside of the first container to provide a deformation of said first container; and   transferring separation resin from the at least one first container to the second container by generating a pressure difference between an interior of the second container and an      
     
     
         40 . The method according to  claim 39 , wherein transferring the separation resin from the first container to the second container is performed according to claim  1 .