Self-contained disposable tubing set for sterile preparation of cells by culturing, centrifugation, and column chromatography

An interconnected assembly of disposable cell separation elements that is configured for sterile processing of a cell population by an automated cell separation apparatus, the elements of the assembly being optionally referred to collectively as a tubing set,

• wherein the assembly comprises:
• (a) a first connector configured for sterile connection to a first source of fluid;
• (b) a second connector configured for sterile connection to a second source of fluid;
• (c) a third connector configured for sterile connection to a sample container;
• (d) a rotatable container that contains a processing chamber, wherein the container is configured to rotate about a rotational axis, thereby applying centrifugal force to cells in the processing chamber so as to separate the cells according to a first characteristic;
• (e) a cell separation column that is configured to separate cells according to a second characteristic;
• (f) a first output container configured to receive cells separated by the apparatus;
• (g) a second output container configured to receive cells separated by the apparatus;
• and
• (h) a system of flow tubes that interconnect the aforelisted elements (a) to (g);
• wherein the interconnected assembly is configured so that a user can perform the following steps:
• (1) installing the assembly on the automated cell separation apparatus;
• then
• (2) connecting a source of media or buffer to the first connector;
• (3) connecting a source of a cell processing reagent to the second connector;
• (4) connecting a container that contains a sample of blood or bone marrow cells to the third connector;
• (5) operating the apparatus so as to obtain cells from the sample container, centrifuge cells from the sample in the processing chamber, combine the cells with the cell processing reagent, separate cells from the sample in the cell separation column, deliver a first separated population of cells from the sample into the first output container, and deliver a second population of cells from the sample into a second output container;
• followed by
• (6) removing the first and second output containers from the apparatus;
• and
• (7) removing the assembly from the apparatus;
• wherein the interconnected assembly is closed so that a sample of cells connected to the first connector in step (4) can be processed within the assembly by the automated cell separation apparatus in a manner that maintains sterility of the cells throughout step (5).