Extra-capillary fluid cycling system and method for a cell culture device

1. A fluid cycling unit for maintaining and cycling fluid volumes in a chamber, comprising:

a housing;

a first flexible fluid reservoir disposed in said housing, said first fluid reservoir being in fluid communication with a chamber;

a second flexible reservoir located in said housing and adjacent to said first reservoir, said second flexible reservoir being in fluid communication with a pressure source;

a sensor plate movably disposed in the housing between said first and second reservoirs, wherein said second reservoir is pressurized to move said sensor plate in relation to said first reservoir to cause fluid cycling and maintain fluid volumes in the chamber; and

a sensor indicator connected to said sensor plate, wherein physical expansion and contraction of said first reservoir moves said sensor indicator within said housing such that the position of said sensor indicator can be sensed by a sensor in communication with a pressure source, and wherein the position of said sensor indicator drives the sensor to increase or reduce pressure within said second reservoir.

2. The fluid cycling unit of claim 1 , further comprising said sensor in communication with the pressure source, wherein said sensor indicator drives the sensor to expand or reduce the pressure within said second flexible reservoir.

3. The fluid cycling unit of claim 1 , wherein said chamber comprises a hollow fiber bioreactor that provides cell space and media component exchange.

4. The fluid cycling unit of claim 1 , wherein said sensor comprises two optical sensors that detect the low or high position of said sensor indicator.

5. The fluid cycling unit of claim 1 , wherein the position of said sensor indicator drives said sensor to increase or reduce pressure within said second reservoir, using a predictive algorithm, to effect cycling.

6. The fluid cycling unit of claim 1 , wherein expansion of said second reservoir forces said sensor plate toward said first reservoir, which compresses said first reservoir and forces fluid into said chamber, and wherein expansion of said first flexible reservoir forces said sensor plate toward said second reservoir, which compresses said second reservoir.

7. The fluid cycling unit of claim 1 , wherein said first reservoir is not vented.

8. An extra-capillary (EC) fluid cycling system for maintaining and cycling fluid volumes in a cell culture chamber of a cell culture environment comprising:

an extra-capillary fluid cycling unit, wherein said cycling unit comprises:

a housing, a first flexible extra-capillary fluid reservoir disposed in said housing,

a second flexible reservoir located in said housing and adjacent to said first reservoir,

a sensor plate movably disposed in said housing between said first and second reservoirs, wherein said first reservoir is in fluid communication with the cell culture chamber, and

a sensor indicator connected to said sensor plate;

a pressure source in communication with said second reservoir;

a sensor in communication with said pressure source, wherein said second reservoir is pressurized to move said sensor plate in relation to first reservoir to cause fluid cycling and maintain fluid volumes in the cell culture chamber, and wherein physical expansion and contraction of said first reservoir moves said sensor indicator within said housing such that the position of said sensor indicator can be sensed by said sensor in communication with said pressure source, and wherein the position of said sensor indicator drives said sensor to increase or reduce pressure within said second reservoir.

9. The extra-capillary fluid cycling unit of claim 8 , wherein the cell culture chamber comprises a hollow fiber bioreactor that provides cell space and media component exchange.

10. The EC fluid cycling system of claim 8 , wherein said sensor comprises two optical sensors that detect the low or high position of said sensor indicator.

11. The EC fluid cycling system of claim 8 , wherein the position of said sensor indicator drives said sensor to increase or reduce pressure within said second reservoir, using a predictive algorithm, to effect cycling.

12. The EC fluid cycling system of claim 8 , wherein expansion of said second reservoir forces said sensor plate toward said first reservoir, which compresses said first reservoir and forces fluid into said chamber, and wherein expansion of said first flexible reservoir forces said sensor plate toward said second reservoir, which compresses said second reservoir.

13. The EC fluid cycling system of claim 8 , wherein when said second reservoir is pressurized to apply force against said first reservoir to provide an elevated EC pressure moving fluid into an intra-capillary (IC) circuit, wherein expanding said second reservoir forces said sensor plate toward said first reservoir, compressing said first reservoir, wherein said sensor plate moves said position indicator, which is sensed when said first reservoir has emptied enough to compress to the EC lower level, whereupon said sensor senses this position, the pressure in the second reservoir is decreased, the pressure in the IC circuit is increased and the first reservoir starts to fill.

14. The EC fluid cycling system of claim 13 , wherein the IC circuit comprises said cell culture chamber, an IC reservoir, a circulation pump, and a gas exchanger.

15. The extra-capillary fluid cycling unit of claim 8 , wherein said first reservoir is not vented.

16. A method for extra-capillary fluid cycling in a cell culture chamber comprising the steps of:

providing an extra-capillary fluid cycling unit, said cycling unit comprising:

a housing,

a first flexible extra-capillary fluid reservoir disposed in the housing,

a second flexible reservoir located in the housing and adjacent to said first reservoir,

a sensor plate movably disposed in said housing between said first reservoir and said second reservoir; and

a sensor indicator connected to said sensor plate;

providing a pressure source in communication with said second reservoir;

providing a sensor in communication with said pressure source, wherein physical expansion and contraction of said first reservoir moves said sensor indicator within said housing such that the position of said sensor indicator can be sensed by said sensor in communication with said pressure source, and wherein the position of said sensor indicator drives said sensor to increase or reduce pressure within said second reservoir;

activating said pressure source to expand or contract said second reservoir;

moving said sensor plate to expand or contract said first reservoir; and

cycling the extra-capillary fluid through the cell culture chamber.

17. The method of claim 16 , wherein said step of cycling the extra-capillary fluid comprises moving the fluid through a cell space of the chamber and exchanging media components.

18. The method of claim 17 , further comprising the step of activating said sensor with said sensor indicator, wherein physical expansion and contraction of said first reservoir moves said sensor indicator within said housing to control the activation of said pressure source.

19. The method of claim 17 , wherein said step of cycling the extra-capillary fluid comprises moving the fluid through a cell space of the chamber and exchanging media components within a fluidically sealed circuit.

20. A cultureware module comprising a chamber and the fluid cycling unit of claim 1 , wherein said chamber is a cell culture chamber.

21. The cultureware module of claim 20 , wherein said chamber comprises a hollow fiber bioreactor that provides cell space and media component exchange.