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1. (WO2015175679) SYSTÈMES ET PROCÉDÉS DE RÉGULATION DE PROCÉDÉS DESTINÉS À ÊTRE UTILISÉS AVEC DES FILTRES ET PROCÉDÉS DE FILTRATION
Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

We claim:

1. A process control system comprising:

(a) one or more upstream processing units, each operating a flow rate;

(b) a tank connected to the one or more upstream processing units;

(c) a filter having an inlet, a permeate outlet and a retentate outlet connected to the tank;

(d) a feed pump having an inlet connected to the tank and an outlet connected to the inlet of the filter;

(e) a sensor disposed at the permeate outlet to determine a flow rate at the permeate outlet; and

(f) a control system that is one of the following (i) through (iv):

(i) coupled to the sensor and the upstream processes, and adapted to control the flow rate of one or more of the one or more upstream processing units according to the flow rate at the permeate outlet,

(ii) coupled to the sensor and the feed pump, and adapted to control the feed pump according to the flow rate at the permeate outlet,

(iii) coupled to the sensor and the feed pump, and adapted to control the feed pump according to the flow rate at the permeate outlet until a predetermined flow rate is reached for the feed pump, and to control the flow rate of one or more of the one or more upstream processing units according to the flow rate at the permeate outlet after the predetermined flow rate is reached for the feed pump, or

(iv) coupled to the sensor and the feed pump, and adapted to control the feed pump according to the flow rate at the permeate outlet until a predetermined flow rate is reached for the feed pump, and to permit a mismatch between the flow rate of the one or more upstream processing units and the flow rate of the feed pump after the predetermined flow rate is reached for the feed pump.

2. The process control system according to claim 1, wherein the control system is (i) coupled to the sensor and the upstream processes, and adapted to control the flow rate of one or more of the one or more upstream processing units according to the flow rate at the permeate outlet.

3. The process control system according to claim 2, wherein the control system is adapted to decrease the flow rate of one or more of the one or more upstream processing units according to a decrease in the flow rate at the permeate outlet.

4. The process control system according to claim 1, wherein the control system is (ii) coupled to the sensor and the feed pump, and adapted to control the feed pump according to the flow rate at the permeate outlet.

5. The process control system according to claim 4, wherein the control system is adapted to control the feed pump to maintain a flow rate at the permeate outlet that is matched to the flow rate of one or more of the one or more upstream processes.

6. The process control system according to claim 1, wherein the control system is (iii) coupled to the sensor and the feed pump, and adapted to control the feed pump according to the flow rate at the permeate outlet until a predetermined flow rate is reached for the feed pump, and to control the flow rate of one or more of the one or more upstream processing units according to the flow rate at the permeate outlet after the predetermined flow rate is reached for the feed pump.

7. The process control system according to claim 1, wherein the control system is (iv) coupled to the sensor and the feed pump, and adapted to control the feed pump according to the flow rate at the permeate outlet until a predetermined flow rate is reached for the feed pump, and to permit a mismatch between the flow rate of the one or more upstream processing units and the flow rate of the feed pump after the predetermined flow rate is reached for the feed pump.

8. The process control system according to any one of claims 6 to 7, wherein the predetermined flow rate is the maximum system flow rate.

9. A process control method for use with one or more upstream processing units each having a flow rate, a tank connected to the one or more upstream processing units, and a filter having an inlet, a permeate outlet and a retentate outlet connected to the tank, the method comprising:

(a) sensing a flow rate at the permeate outlet; and

(b) performing one of the following (i) through (iv):

(i) controlling a flow rate of one or more of the one or more upstream processing units according to the flow rate at the permeate outlet,

(ii) pumping material from the tank into the filter according to the flow rate at the permeate outlet,

(iii) pumping material from the tank into the filter according to a flow rate at the permeate outlet until a predetermined pumping flow rate is reached, and subsequently controlling the flow rate of one or more of the one or more upstream processing units once the predetermined pumping flow rate is reached, or

(iv) pumping material from the tank into the filter according to the flow rate at the permeate outlet until a predetermined pumping flow rate is reached, and subsequently pumping material from the tank into the filter to according to the predetermined pumping flow rate thereby permitting the volume in the tank to vary.

10. The process control method according to claim 9, wherein (b)(i) is performed.

11. The process control method according to claim 10, wherein the flow rate of one or more of the one or more upstream processing units is decreased according to a decrease in the flow rate at the permeate outlet.

12. The process control method according to claim 9, wherein (b)(ii) is performed.

13. The process control method according to claim 12, wherein the flow rate at the permeate outlet is matched to the flow rate of one or more of the one or more upstream processes.

14. The process control method according to claim 9, wherein (b)(iii) is performed.

15. The process control method according to claim 9, wherein (b)(iv) is performed.

16. The process control method according to any one of claims 14 to 15, wherein the predetermined flow rate is the maximum system flow rate.

17. A process of purifying a protein utilizing one or more upstream processing units each having a flow rate, a tank connected to the one or more upstream processing units, and a filter having an inlet, a permeate outlet and a retentate outlet connected to the tank, the process comprising:

(a) sensing a flow rate at the permeate outlet while the protein flows from the retentate outlet back to the tank;

(b) performing one of (i) through (iv):

(i) controlling a flow rate of one or more of the one or more upstream processing units according to the flow rate at the permeate outlet, the flow rate being a flow rate of a material at least partly including the protein,

(ii) pumping a material at least partly including the protein from the tank into the filter according to the flow rate at the permeate outlet,

(iii) pumping a material at least partly including the protein from the tank into the filter according to a flow rate at the permeate outlet until a predetermined pumping flow rate is reached, and subsequently controlling the flow rate of one or more of the one or more upstream processing units once the predetermined pumping flow rate is reached, or

(iv) pumping a material at least partly including the protein from the tank into the filter according to the flow rate at the permeate outlet until a predetermined pumping flow rate is reached, and subsequently pumping material from the tank into the filter to according to the predetermined pumping flow rate thereby permitting the volume in the tank to vary; and

(c) purifying the protein in an eluate.

18. The process control method according to claim 17, further comprising formulating the protein in a pharmaceutically acceptable excipient.

19. The process control method according to any one of claims 17 to 18, wherein (b)(i) is performed.

20. The process control method according to claim 19, wherein the flow rate of one or more of the one or more upstream processing units is decreased according to a decrease in the flow rate at the permeate outlet.

21. The process control method according to any one of claims 17 to 18, wherein (b)(ii) is performed.

22. The process control method according to claim 21, wherein the flow rate at the permeate outlet is matched to the flow rate of one or more of the one or more upstream processes.

23. The process control method according to any one of claims 17 to 18, wherein (b)(iii) is performed.

24. The process control method according to any one of claims 17 to 18, wherein (b)(iv) is performed.

25. The process control method according to any one of claims 23 to 24, wherein the predetermined flow rate is the maximum system flow rate.

26. A process control system comprising:

a microfiltration unit;

a single -pass tangential flow filter having an inlet, a permeate outlet and a retentate outlet;

a feed pump with an inlet connected to the microfiltration unit and an outlet connected to the inlet of the filter;

a permeate pump with an inlet connected to the permeate outlet of the filter; and

a control system coupled to the permeate pump and adapted to control the permeate pump to vary a flow reduction factor, where the flow reduction factor is the ratio of feed flow to retentate flow.

27. The process control system according to claim 26, wherein the control system is adapted to control the permeate pump to vary the flow reduction factor to achieve a target volume reduction factor, where the volume reduction factor is the ratio of cumulative feed volume to cumulative retentate volume.

28. The process control system according to claim 26, wherein the control system is adapted to control the permeate pump to vary the flow reduction factor in a series of stepwise changes.

29. The process control system according to claim 28, wherein the control system is adapted to control the permeate pump to vary the flow reduction factor in a series of stepwise increases.

30. The process control system according to claim 26, wherein the control system is adapted to control the permeate pump to vary the flow reduction factor continuously.

31. The process control system according to claim 26, wherein the control system is adapted to operate the permeate pump to provide a first flow reduction factor, to subsequently change to a second flow reduction factor that is different than the first flow reduction factor, and to operate the permeate pump to provide the second flow reduction factor.

32. The process control system according to claim 26, wherein the control system comprises at least one processor, the at least one processor programmed to control the permeate pump to vary the flow reduction factor.

33. The process control system according to claim 32, wherein the at least one processor is programmed to control the permeate pump to vary the flow reduction factor to achieve a target volume reduction factor, where the volume reduction factor is the ratio of cumulative feed volume to cumulative retentate volume.

34. The process control system according to claim 32, wherein the at least one processor is programmed to control the permeate pump to vary the flow reduction factor in a series of stepwise changes.

35. The process control system according to claim 34, wherein the at least one processor is programmed to control the permeate pump to vary the flow reduction factor in a series of stepwise increases.

36. The process control system according to claim 32, wherein the at least one processor is programmed to control the permeate pump to vary the flow reduction factor continuously.

37. The process control system according to claim 32, wherein the at least one processor is programmed to operate the permeate pump to provide a first flow reduction factor, to subsequently change to a second flow reduction factor that is different than the first flow reduction factor, and to operate the permeate pump to provide the second flow reduction factor.

38. The process control system according to claim 26, wherein the control system is coupled to the feed pump and adapted to control the feed pump to provide a constant flow rate.

39. The process control system according to claim 26, comprising a valve disposed between the retentate outlet and a mixing tank, the controller coupled to the valve and adapted to control the valve to provide a backpressure for the filter.

40. A process control method comprising:

pumping material through a single-pass tangential flow filter having an inlet, a permeate outlet and a retentate outlet; and

pumping permeate from the permeate outlet of the filter to vary a flow reduction factor, where the flow reduction factor is the ratio of feed flow to retentate flow.

41. The process control method according to claim 40, wherein the flow reduction factor is varied to achieve a target volume reduction factor, where the volume reduction factor is the ratio of cumulative feed volume to cumulative retentate volume.

42. The process control method according to claim 40, wherein the flow reduction factor is varied in a series of stepwise changes.

43. The process control method according to claim 42, wherein the flow reduction factor is varied in a series of stepwise increases.

44. The process control method according to claim 40, wherein the flow reduction factor is varied continuously.

45. The process control method according to claim 40, wherein pumping permeate comprises pumping permeate according to a first flow reduction factor, subsequently changing to a second flow reduction factor that is different than the first flow reduction factor, and pumping the permeate according to the second flow reduction factor.

46. The process control method according to claim 40, wherein the pumping material comprises pumping material at a constant feed flow.

47. The process control method according to claim 40, wherein the material comprises cellular material and a protein product.

48. The process control method according to claim 47, wherein the protein product comprises a monoclonal antibody.

49. The process control method according to any one of claims 40 to 48, wherein the material at least partly comprises a protein and the process further comprises purifying the protein with an eluate.

50. The process control method according to claim 49, further comprising formulating the protein in a pharmaceutically acceptable excipient.