Disposable bioreactor systems and methods

• US 20050272146A1
• Filed: 06/06/2005
• Published: 12/08/2005
• Est. Priority Date: 06/04/2004
• Status: Active Grant

• Current Assignee: Global Life Sciences Solutions USA LLC (Danaher Corporation)
• Original Assignee: Xcellerex, Inc. (General Electric Company)
• Inventors: Fisher, Michael, Hodge, Geoffrey, Galliher, Parrish
• Granted Patent: US 7,629,167 B2
• Time in Patent Office: Days
• US Class Current: 435/289.100
• CPC Class Codes: B01F 2101/44 Mixing of ingredients for microbiology, enzymology, in vitro culture or genetic manipulation
• CPC Class Codes: B01F 33/453 using supported or suspended stirring elements
• CPC Class Codes: B01F 35/513 Flexible receptacles, e.g. bags supported by rigid containers
• CPC Class Codes: B01F 35/5312 with vertical baffles mounted on the walls
• CPC Class Codes: C12M 23/14 Bags
• CPC Class Codes: C12M 27/02 Stirrer or mobile mixing elements
• CPC Class Codes: C12M 27/20 Baffles; Ribs; Ribbons; Auger vanes
• CPC Class Codes: C12M 41/12 of temperature controlling the temperature of chemical or physical processes B01J19/0013, heating or cooling apparatus for laboratory use B01L7/00
• CPC Class Codes: C12M 41/26 of pH
• CPC Class Codes: C12M 41/34 of gas
• CPC Class Codes: C12M 41/48 Automatic or computerized control automatic analysis G01N35/00

Abstract

Accordingly, in one embodiment of the invention, a bioreactor system is presented and includes a disposable container for housing biomaterials for processing, the disposable container including at least one input port, at least one exhaust port, at least one harvest port, and the integrity of the sterile environment is protected with sterile filters attached to all external open ports a structure for supporting the disposable container, one or more sensors for sensing one or more parameters of the biomaterials in the container, a heater for heating the contents of the container, the heater having a thermostat and mixing system arranged with the system such that biomaterials contained in the disposable container are mixed.

Claims

1. A bioreactor system comprising:

a disposable container for housing biomaterials for processing, the disposable container including at least one input port, at least one exhaust port;

at least one harvest port;

a structure for supporting the disposable container;

one or more sensors for sensing one or more parameters of the biomaterials in the container;

a heater for heating the contents of the container, the heater having a thermostat; and

mixing system arranged with the system such that biomaterials contained in the disposable container are mixed.

2. The bioreactor according to claim 1, wherein the disposable container comprises a plastic container or a flexible plastic bag.

3. The bioreactor according to claim 1, wherein the disposable container includes one or more baffles.

4. The bioreactor according to claim 1, wherein the mixing system comprises a bubble column in conjunction with a divider positioned in the interior of the container.

5. The bioreactor according to claim 1, wherein the mixing means comprises an impeller positioned within the container at a lower portion of the container, driven by a motor external to the container.

6. The bioreactor according to claim 5, wherein the impeller is magnetically coupled to the motor.

7. The bioreactor according to claim 5, wherein the impeller is mechanically coupled to the motor.

8. The bioreactor according to claim 1, wherein the heater comprises an area of material positioned on the exterior of the vessel holding the disposable container.

9. The bioreactor according to claim 1, wherein the heater comprises a blanket of material or metal jacket containing heated or cooled water wrapped around at least a portion on the exterior of the vessel holding the disposable container.

10. The bioreactor according to claim 9, wherein the heater is positioned within or on the exterior of the disposable container.

11. The bioreactor according to claim 1, wherein the one or more sensors comprise sensors for detecting at least one of dissolved oxygen, dissolved carbon dioxide, mixing rate, gas flow rate, temperature, pH and pressure.

12. The bioreactor system according to claim 1, further comprising a computer for controlling the system.

13. The bioreactor system according to claim 1, further comprising at least one of an air supply, a carbon dioxide supply, and oxygen supply.

14. The bioreactor system according to claim 1, further comprising transporting means for moving the support structure.

15. The bioreactor system according to claim 14, wherein the transporting means comprises a dolly.

16. A bioreactor system comprising:

a support structure;

a flexible plastic bag positioned within the support structure, the disposable container including;

an impeller plate affixed to a lower portion of the flexible plastic bag, the impeller plate including a post;

an impeller hub mounted on the post, the impeller hub having at least one impeller blade arranged on the post and having at least one magnet;

a motor having shaft, the motor being provided adjacent to or within the support structure; and

a motor hub mounted on the motor shaft, the motor hub including at least one magnet, wherein upon mounting of the flexible plastic bag within the support structure, the motor hub aligns with the impeller plate such that the magnet of the motor hub may align with the magnet of the impeller hub to drive the impeller hub when the motor shaft rotates.

17. The bioreactor system according to claim 16, wherein the motor hub further includes a lazy-susan bearing, wherein the bearing is positioned within the hub such that a portion of the bearing contacts one side of the impeller plate.

18. The bioreactor system according to claim 16, wherein the impeller plate further includes at least one porous element arranged to allow one or two-way fluid communication between an interior of the flexible plastic bag and an exterior of the flexible plastic bag.

19. The bioreactor system according to claim 18, wherein the fluid communication comprises introducing a gas sparge to the interior of the flexible plastic bag or removing fluids from the interior of the flexible plastic bag.

20. The bioreactor system according to claim 16, wherein the at least one impeller blade comprises a variable pitch impeller blade.

21. The bioreactor system according to claim 20, wherein the pitch of the impeller blade changes depending upon the rotational speed of the impeller hub.

22. The bioreactor system according to claim 20, wherein the pitch of the impeller blade is manually adjusted.

23. A bioreactor system comprising:

a support structure;

a flexible plastic bag positioned within the support structure, the disposable container including;

an impeller plate affixed to a lower portion of the flexible plastic bag;

a first shaft having a first end positioned within the interior of the flexible plastic bag and having a second end positioned on an exterior of the flexible plastic bag;

a seal surrounding the shaft;

an impeller hub mounted on the first end of the shaft, the impeller hub having at least one impeller blade arranged on the shaft;

a motor arranged adjacent to or within the support structure, upon mounting of the flexible plastic bag within the support structure, the second end of the shaft is driven by the motor.

24. The bioreactor system according to claim 23, wherein the impeller plate and/or seal includes a bearing.

25. The bioreactor system according to claim 23, wherein the impeller plate further includes at least one porous element arranged to allow one or two-way fluid communication between an interior of the flexible plastic bag and an exterior of the flexible plastic bag.

26. The bioreactor system according to claim 25, wherein the fluid communication comprises introducing a gas sparge to the interior of the flexible plastic bag or removing fluids from the interior of the flexible plastic bag.

27. The bioreactor system according to claim 23, wherein the at least one impeller blade comprises a variable pitch impeller blade.

28. The bioreactor system according to claim 27, wherein the pitch of the impeller blade changes depending upon the rotational speed of the impeller hub.

29. The bioreactor system according to claim 27, wherein the pitch of the impeller blade is manually adjusted.