CELL PROCESSING CONTAINER, CELL PROCESSING SYSTEM AND METHODS OF USE THEREOF
The present disclosure relates to a cell processing container for use in one or more unit operations in cell and/or gene therapy manufacture, the container having a base section, a top section arranged substantially in parallel with the base section and a wall element arranged between the top section and the base section and defining an internal lumen of the container, in which the wall element of the cell culture container preferably is compressible with respect to the top and base section and the wall element of the cell culture container is composed of a flexible material, wherein the cell processing container comprises at least one sterile connector end configured to operatively couple with a further sterile connector end to form a sterile connector between the cell processing container and a further container to which the cell processing container is to be fluidly connected.
1 . A cell processing container for use in one or more unit operations in cell or gene therapy manufacture, the cell processing container comprising:
a base section, a top section arranged substantially in parallel with the base section and a wall element arranged between the top section and the base section and defining an internal lumen of the container,
wherein the wall element of the cell processing container is compressible with respect to the top and base section,
wherein the wall element of the cell processing container comprises a flexible material, and
wherein the cell processing container comprises at least one sterile connector end configured to operatively couple with a further sterile connector end to form a sterile connector between the cell processing container and a further component to which the cell processing container is to be fluidly connected.
2 . The cell processing container of claim 1 , wherein the at least one sterile connector end is a genderless sterile connector end configured to operatively couple with a further genderless sterile connector end.
3 . The cell processing container of claim 1 , wherein the at least one sterile connector end is a male sterile connector end configured to operatively couple with a female sterile connector end.
4 . The cell processing container of claim 1 , wherein the at least one sterile connector end is a female sterile connector end configured to operatively couple with a male sterile connector end.
5 . The cell processing container of claim 1 , comprising a plurality of sterile connector ends each configured to operatively couple with a separate further sterile connector end to form a plurality of sterile connectors between the cell processing container and at least one further component to which the cell processing container is to be fluidly connected.
6 . The cell processing container of claim 1 , comprising a plurality of sterile connector ends that are embedded in the cell processing container.
7 . The cell processing container of claim 1 , wherein the at least one sterile connector end is operatively coupled to a pinch valve embedded in the cell processing container.
8 . The cell processing container of claim 1 , wherein the cell processing container has a circular, square, rectangular, elliptical, or triangular cross section.
9 . The cell processing container of claim 8 , wherein the cell processing container has a circular shape and a number of sterile connector ends are connected to one or more of the top or base section of the cell processing container in a substantially circular pattern.
10 . A cell processing system, comprising:
a cell processing container for use in one or more unit operations in cell or gene therapy manufacture, the cell processing container comprising:
a base section, a top section arranged substantially in parallel with the base section and a wall element arranged between the top section and the base section and defining an internal lumen of the container,
wherein the wall element of the cell processing container is compressible with respect to the top and base section,
wherein the wall element of the cell processing container comprises a flexible material, and
wherein the cell processing container comprises at least one sterile connector end configured to operatively couple with a further sterile connector end to form a sterile connector between the cell processing container and a further component to which the cell processing container is to be fluidly connected, and
one or more auxiliary containers detachably connected to the cell processing container.
11 . The cell processing system of claim 10 , wherein a respective auxiliary container of the one or more auxiliary containers comprise the further sterile connector end and is connected to the cell processing container via the further sterile connector end.
12 . The cell processing system of claim 10 , wherein the one or more auxiliary containers are located on the top section of the cell processing container.
13 . The cell processing system of claim 10 , wherein the one or more auxiliary containers are located at or near the base section of the cell processing container.
14 . The cell processing system of any one of claim 10 , wherein the one or more auxiliary containers respectively comprise: a base section, a top section arranged substantially in parallel with the base section and a wall element arranged between the top section and the base section and defining an internal lumen of the container, wherein the wall element is compressible with respect to the top and base section, and wherein the wall element comprises a flexible material.
15 . A method, comprising controlling one or more unit operations in cell or gene therapy manicuring utilizing a cell processing system comprising:
a cell processing container for use in one or more unit operations in cell or gene therapy manufacture, the cell processing container comprising:
a base section, a top section arranged substantially in parallel with the base section and a wall element arranged between the top section and the base section and defining an internal lumen of the container,
wherein the wall element of the cell processing container is compressible with respect to the top and base section,
wherein the wall element of the cell processing container comprises a flexible material, and
wherein the cell processing container comprises at least one sterile connector end configured to operatively couple with a further sterile connector end to form a sterile connector between the cell processing container and a further component to which the cell processing container is to be fluidly connected, and
one or more auxiliary containers detachably connected to the cell processing container.
16 . The method of claim 15 , comprising: introducing a cell population of interest into the cell processing container and sequentially adding one or more reagents from one or more auxiliary containers into the cell processing container.