Apparatus and process for the automated manufacturing of genetically engineered cells from biological fluids
An automated apparatus suitable for the preparation of genetically transformed cells from biological fluids including of an operating unit and a rotating concentric hollow processing chamber able to automatically process biological samples, such as white blood cells from apheresis, bone marrow or cultured cells, to manufacture genetically engineered cells. The operating unit is rotatable around its center about a horizontal axis and the processing chamber is rotatable about its central rotor axis perpendicular with the rotating axis of the operating unit. The processing chamber can be operated at high rotating speeds when oriented vertically to generate centrifugal force on the contained sample allowing separation of solids from liquids and at low speeds or by series of fast sequential clockwise and counterclockwise rotations when oriented horizontally for incubation, solid resuspension and magnetic beads magnetic attachment.
1 . A rotating concentric hollow chamber configured for receiving fluids,
the rotating concentric hollow chamber being adapted for being operated by an operating unit operated in multiple orientations in space for performing cell processing,
the rotating concentric hollow chamber comprises two parts, a spherical top part and a narrow funnel shaped bottom part,
wherein the top part is a half sphere with the round part facing up with a protruding hole at its very top, and
wherein the narrow funnel shaped bottom part comprise a bottom hole at the very bottom of the funnel shape,
wherein in that the rotating concentric hollow chamber is rotatable about a central axis in both directions and rotatable about an external axis perpendicular to said central axis, so that when the rotating concentric hollow chamber is operated by means of the operating unit, the rotating concentric hollow chamber is shifted from a vertical to a horizontal position, and
wherein the narrow funnel shaped bottom part comprises a bottom edge of the half sphere positioned between a quarter and halfway of the total height of the rotating concentric hollow chamber forming a perpendicular angle with the bottom part of the rotating concentric hollow chamber which narrows down into a funnel shape that follows a concave arched curve with the bottom hole at its very bottom.
2 . The rotating concentric hollow chamber of claim 1 , wherein the bottom edge is characterized by a specific angle configured for serving as a location for solids to aggregate and attach upon centrifugation of said rotating concentric hollow chamber.
3 . The rotating concentric hollow chamber of claim 1 , wherein the rotating concentric hollow chamber is manufactured in medical grade plastic.
4 . The rotating concentric hollow chamber of claim 3 , wherein the medical grade plastic is chosen among polyethylene terephthalate or polystyrene.
5 . The rotating concentric hollow chamber of claim 1 , wherein the rotating concentric hollow chamber is fitted with an inlet stator at a top of the rotating concentric hollow chamber and an outlet stator at a bottom of the rotating concentric hollow chamber allowing liquids to be pumped in and out of the rotating concentric hollow chamber.
6 . A single use disposable kit comprising a rotating concentric hollow chamber according to claim 1 ,
wherein the rotating concentric hollow chamber is fitted with an inlet stator at a top of the rotating concentric hollow chamber and an outlet stator at a bottom of the rotating concentric hollow chamber allowing liquids to be pumped in and out of the rotating concentric hollow chamber,
and wherein each of the inlet stator and the outlet stator are connected to an independent set composed of a disposable peristaltic pump head connected to a disposable multiple-way rotary selector valve head connected to several reagent or product pouches.
7 . An automated apparatus suitable for the preparation of genetically transformed cells from biological fluids comprising the operating unit that is rotatable around its center about a horizontal axis,
wherein the operating unit comprises the rotating concentric hollow chamber according to claim 1 .
8 . The automated apparatus of claim 7 , wherein the apparatus further comprises a central axis shaft holding the operating unit providing support and electrical power.
9 . The automated apparatus of claim 7 , wherein the rotating concentric hollow chamber is fitted with an inlet stator at a top of the rotating concentric hollow chamber and an outlet stator at a bottom of the rotating concentric hollow chamber allowing liquids to be pumped in and out of the rotating concentric hollow chamber.
10 . The automated apparatus of claim 9 , wherein each of the inlet stator and the outlet stator are connected to an independent set composed of a disposable peristaltic pump head connected to a disposable multiple-way rotary selector valve head connected to several reagent or product pouches so as to form a disposable kit.
11 . The automated apparatus of claim 7 , wherein the operating unit is shaped as a hexagonal prism that possesses different functions for each of six operating unit faces and that can accommodate the rotating concentric hollow chamber in a rotor housing on one of the faces.
12 . The automated apparatus of claim 11 , wherein the six operating unit faces comprise:
two faces that are chambers configured for the storage of liquid bags that can be temperature controlled,
one face which is the rotor housing that holds the rotating concentric hollow chamber and is equipped with an actionable magnetic array,
one face that comprises a user interface as well as attachment points for a first peristaltic pump head and a first multiple-way rotary selector valve head,
one face that comprises attachment points for a second peristaltic pump head and a second multiple-way rotary selector valve head and,
one face that contains data input/output connectors, power connectors as well as venting for temperature control.
13 . The automated apparatus of claim 12 , wherein the actionable magnetic array consists in an arched shape designed to fit the bottom edge of the rotating concentric hollow chamber and further comprising one or more high magnetic field strength magnets.