Systems and Methods for Point/Center-Of-Care Immunotherapy

Abstract

A cell modification device, comprising a centrifugation chamber with at least one cell modifying surface with a normal vector having an angle of 135-45° to the rotational axis of the centrifugation chamber, wherein the centrifugation chamber comprises at least one input/output port and the cells to be modified are immobilized at the cell modifying surfaces by the rotation of the centrifugation chamber at 2 to 2000 g. In an embodiment, the device is used as a point-of-care and/or portable device. Further, the present disclosure describes software that, when executed by a processor, causes the device to perform the disclosed functions.

What is claimed is: 
     
         1 . A method of separating, genetically-modifying, and formulating target cells obtained from a subject sample, the method comprising the steps of:
 (i) loading the subject sample into a cell modification device comprising:
 a fluidic circuit for processing the subject sample cells, the fluidic circuit comprising a sample input, a buffer input, and a centrifugal chamber; 
 a plurality of valves for selectively closing one or more flow paths of the fluidic circuit; 
 one or more selector(s) for separating cells to be modified of the subject sample cells from the remaining subject sample cells; 
 at least one pump to introduce the subject sample cells through at least a portion of the fluidic circuit; 
 memory storing instructions executable by one or more processors to control operation of the centrifugal chamber, the plurality of valves, the cell selector(s), and the pump; and 
   (ii) initiating execution of the instructions by the one or more processors to cause at least one of the plurality of valves, the one or more cell selectors, or the at least one pump to perform acts comprising:
 transferring the subject sample cells from the centrifugal chamber to the cell selector(s); 
 separating the cells to be modified from the remaining subject sample cells via operation of the cell selector(s) simultaneously or in tandem if more than one selector is used; 
 transferring the cells to be modified back into to the centrifugal chamber; 
 introducing a genetic modifier to the cells to be modified within the centrifugal chamber and/or the cell selector(s) to generate genetically-modified cells; and 
 formulating the genetically-modified cells into a formulation for therapeutic injection into a patient.