IP Library › Granted Patent US 12,214,092
Granted Patent B2
US 12,214,092 · App. 18/084,344 · Granted Feb 4, 2025

Systems and methods for treating biological fluids

Inventors: Daniel Church (Danville, CA); Peter Bringmann (Concord, CA); Grace Castro (Martinez, CA); Thea Lu (Pleasant Hill, CA); Shelby Reinhardt (San Francisco, CA); Felicia Santa Maria (Bay Point, CA); Adonis Stassinopoulos (Del Mar, CA)
Assignee: Cerus Corporation
A61L2/0047A01N1/0215A01N1/0294A61K31/37A61K41/17A61L2/0076A61L2/26A61M1/3683B01J19/123H01L25/0753A61L2/24A61L2202/11A61L2202/122A61L2202/14A61L2202/22A61M2202/0415A61M2202/0427
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Quick Facts
Patent No.
US 12,214,092
App. No.
18/084,344
Granted
Feb 4, 2025
Kind
B2
Abstract

Provided are systems and methods for treating a biological fluid, e.g., to inactivate pathogens.

Claims (74)

1. A method for treating a biological fluid comprising:

providing a biological fluid in admixture with a photoactive pathogen inactivation compound; and

illuminating the biological fluid with ultraviolet light with a first peak wavelength of from about 315 nm to about 350 nm emitted by a set of one or more first light sources, wherein each of the one or more first light sources emits light has a full-width half-maximum (FWHM) spectral bandwidth of less than 20 nanometers, and

wherein illuminating the biological fluid occurs for a duration and at an intensity sufficient to inactivate a pathogen in the biological fluid when present.

2. The method of claim 1 , wherein the first peak wavelength is from about 315 to about 335 nm.

3. The method of claim 1 , wherein the first peak wavelength is from about 330 nm to about 350 nm.

4. The method of claim 1 , wherein the first peak wavelength is a peak wavelength of one first light source of the set of one or more first light sources.

5. The method of claim 4 , wherein the first peak wavelength is a peak wavelength of each of a plurality of first light sources of the set of one or more first light sources.

6. The method of claim 1 , wherein the first peak wavelength is an average peak wavelength of the set of one or more first light sources.

7. The method of claim 1 , further comprising illuminating the biological fluid with ultraviolet light with a second peak wavelength emitted by a set of one or more second light sources, wherein each of the one or more second light sources emits light has a full-width half-maximum (FWHM) spectral bandwidth of less than 20 nanometers, and wherein the second peak wavelength differs from first peak wavelength by at least 5 nm.

8. The method of claim 7 , wherein the second peak wavelength is a peak wavelength of one second light source of the set of one or more second light sources.

9. The method of claim 8 , wherein the second peak wavelength is a peak wavelength of each of a plurality of second light sources of the set of one or more second light sources.

10. The method of claim 7 , wherein the second peak wavelength is an average peak wavelength of the set of one or more second light sources.

11. The method of claim 1 , wherein the set of one or more first light sources comprises one or more LEDs.

12. The method of claim 1 , wherein the biological fluid is contained within a container, and wherein the set of one or more first light sources is disposed as an array of light sources, the set of one or more first light sources facing only one side of the container.

13. The method of claim 1 , wherein the photoactive pathogen inactivation compound is a psoralen.

14. The method of claim 13 , wherein the photoactive pathogen inactivation compound is amotosalen.

15. The method of claim 1 , further comprising, prior to illuminating the biological fluid with the ultraviolet light with the first peak wavelength:

introducing the biological fluid in admixture with the photoactive pathogen inactivation compound into a treatment chamber, the treatment chamber comprising one or more light sensors configured to detect light in the treatment chamber and a first array of light sources configured to illuminate the biological fluid in the treatment chamber, wherein the first array of light sources comprises a first light source channel comprising the set of one or more first light sources,

wherein illuminating the biological fluid comprises emitting light with the first peak wavelength from the first light source channel for a first duration and at a first intensity sufficient to inactivate a pathogen in the biological fluid when present.

16. The method of claim 15 , wherein each light source of the first light source channel is configured to emit ultraviolet light with a first peak wavelength between about 315 nm and about 350 nm.

17. The method of claim 15 , further comprising,

determining a set of characteristics of the biological fluid;

determining a treatment profile based on the set of characteristics of the biological fluid; and

adjusting or setting a set of parameters of the treatment chamber in accordance with the treatment profile.

18. The method of claim 17 , wherein illuminating the biological fluid is performed in accordance with the treatment profile, and wherein the first duration and the first intensity sufficient to inactivate the pathogen are determined from the treatment profile.

19. The method of claim 15 , wherein the first array of light sources comprises a second light source channel configured to emit light of a second peak wavelength.

20. The method of claim 19 , wherein the second peak wavelength differs from the first peak wavelength by at least 5 nm.

21. The method of claim 19 , wherein the second peak wavelength is in an ultraviolet A, ultraviolet B, or ultraviolet C spectrum.

22. The method of claim 19 , wherein the second light source channel comprises a set of one or more second light sources, wherein each of the one or more second light sources emits light having a full-width half-maximum (FWHM) spectral bandwidth of less than 20 nanometers.

23. The method of claim 17 , wherein the set of characteristics of the biological fluid includes one or more of a group comprising: a volume of the biological fluid, a type of the biological fluid, and a temperature of the biological fluid.

24. The method of claim 17 , wherein determining the treatment profile based on the set of characteristics of the biological fluid comprises determining the first intensity of light with the first peak wavelength or determining the first duration of emission of light with the first peak wavelength.

25. The method of claim 15 , wherein the treatment chamber further comprises a first platform positioned in the treatment chamber, the first platform carrying the biological fluid.

26. The method of claim 25 , wherein adjusting or setting a set of parameters of the treatment chamber comprises adjusting or setting a distance between the first array of light sources and the first platform.

27. The method of claim 1 , further comprising agitating the biological fluid.

28. The method of claim 1 , wherein a total dose of the ultraviolet light illuminating the biological fluid is about 0.5 J/cm 2 to about 50 J/cm 2 .

29. The method of claim 28 , wherein the total dose of the ultraviolet light illuminating the biological fluid emitted by the set of one or more first light sources is about 0.5 J/cm 2 to about 50 J/cm 2 .

30. The method of claim 1 , wherein the method for treating is sufficient to inactivate at least 1 log of a pathogen in the biological fluid when present, and wherein the biological fluid after illuminating is suitable for infusion into a subject without further processing to remove residual pathogen inactivation compound or photoproduct(s) thereof.

31. The method of claim 1 , wherein the method for treating is sufficient to inactivate at least 1 log of a pathogen in the biological fluid when present, and wherein the biological fluid after illuminating is suitable for infusion into a subject without subjecting the biological fluid to a compound removal step to remove residual pathogen inactivation compound or photoproduct(s) thereof.

32. The method of claim 1 , wherein the method for treating is sufficient to inactivate at least 1 log of a pathogen in the biological fluid when present, and wherein the biological fluid comprises 5 μM or less of the photoactive pathogen inactivation compound after illuminating.

33. The method of claim 1 , wherein the method for treating is sufficient to inactivate at least 1 log of a pathogen in the biological fluid when present, and wherein the biological fluid comprises 2 μM or less of the photoactive pathogen inactivation compound after illuminating.

34. The method of claim 1 , wherein a concentration of the photoactive pathogen inactivation compound in admixture with the biological fluid prior to illuminating is at least about 10 μM or at least about 50 μM.

35. The method of claim 1 , wherein a concentration of the photoactive pathogen inactivation compound in admixture with the biological fluid prior to illuminating is about 15 μM to about 150 μM.

36. The method of claim 1 , wherein a concentration of the photoactive pathogen inactivation compound in admixture with the biological fluid after illuminating is at least 3-fold less than the concentration of the photoactive pathogen inactivation compound in admixture with the biological fluid prior to illuminating.

37. The method of claim 1 , wherein the method for treating is sufficient to inactivate at least 4 log of a pathogen in the biological fluid when present.

38. The method of claim 1 , wherein the biological fluid after illuminating maintains sufficient biological activity so that the biological fluid is suitable for infusion into a subject.

39. The method of claim 1 , wherein the biological fluid comprises a blood product.

40. The method of claim 1 , wherein the biological fluid comprises a plasma composition.

41. The method of claim 40 , wherein a concentration of fibrinogen in the plasma composition after illuminating is at least 70% of the concentration of fibrinogen in the plasma composition prior to illuminating.

42. The method of claim 40 , wherein a concentration of factor VIII in the plasma composition after illuminating is at least 70% of the concentration of factor VIII in the plasma composition prior to illuminating.

43. The method of claim 1 , wherein the biological fluid comprises a platelet composition.

44. The method of claim 43 , wherein the biological fluid further comprises a platelet additive solution.

45. The method of claim 43 , wherein an amount of platelets in the platelet composition after illuminating is at least 80% platelet recovery.

46. The method of claim 43 , wherein the pH at 22° C. of the platelet composition after illuminating is at least 6.2.

47. The method of claim 1 , wherein the method comprises, prior to illuminating, incubating the biological fluid with the photoactive pathogen inactivation compound for a period of from 30 minutes to 24 hours.

48. The method of claim 3 , wherein the first peak wavelength is from about 340 nm to about 350 nm.

49. The method of claim 3 , wherein the first peak wavelength is 345±5 nm.

50. The method of claim 2 , wherein the first peak wavelength is from about 320 to about 330 nm.

51. The method of claim 2 , wherein the first peak wavelength is 325±5 nm.

52. The method of claim 7 , wherein the set of one or more second light sources comprises one or more LEDs.

53. The method of claim 1 , wherein the biological fluid is contained within a container, and wherein the set of one or more first light sources is disposed as a first array of light sources and a second array of light sources, the first array and the second array facing opposite sides of the container.

54. The method of claim 15 , wherein the treatment chamber further comprises a second array of light sources configured to illuminate the biological fluid in the treatment chamber, wherein the second array of light sources comprises a first light source channel of the second array of light sources comprising a set of one or more second light sources configured to emit light of a first peak wavelength of the second array, wherein illuminating the biological fluid comprises emitting light with the first peak wavelength of each of the first array of light sources and second array of light sources, for a first duration and at first intensity sufficient to inactivate a pathogen in the biological fluid when present.

55. The method of claim 54 , wherein the first peak wavelength of the second array of light sources is substantially the same as the first peak wavelength of the first array of light sources.

56. The method of claim 54 , wherein the second array of light sources comprises a second light source channel of the second array of light sources configured to emit light of a second peak wavelength, and wherein the second peak wavelength of the second array of light sources is substantially the same as the second peak wavelength of the first array of light sources.

57. The method of claim 1 , further comprising, prior to illuminating the biological fluid with the ultraviolet light with the first peak wavelength:

introducing the biological fluid in admixture with the photoactive pathogen inactivation compound into a system for treating the biological fluid, the system comprising:

a treatment chamber configured to receive the biological fluid;

one or more sensors configured to detect light in the treatment chamber;

a first array of light sources positioned to illuminate the biological fluid in the treatment chamber, wherein the first array of light sources comprises a first light source channel configured to emit ultraviolet light with a first peak wavelength of from about 315 nm to about 350 nm, and wherein the first light source channel comprises one or more light sources, each of which emits light having a full-width half-maximum (FWHM) spectral bandwidth of less than 20 nanometers; and

control circuitry, wherein the control circuitry comprises:

a memory;

one or more processors; and

one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors, the one or more programs when executed by the one or more processors cause the processor to: illuminate the biological fluid in admixture with the photoactive pathogen inactivation compound by controlling the first array of light sources to illuminate light for a duration and at an intensity sufficient to inactivate a pathogen in the biological fluid when present; and

illuminating the biological fluid for the duration and at the intensity sufficient to inactivate the pathogen in the biological fluid when present.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded May 20, 2026
From: MIDCAP FUNDING IV TRUST
To: CERUS CORPORATION
Reel/Frame 075583/0598 →
RELEASE OF SECURITY INTEREST Recorded May 20, 2026
From: MIDCAP FINANCIAL TRUST
To: CERUS CORPORATION
Reel/Frame 075610/0621 →
AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT (REVOLVING LOAN) Recorded Aug 29, 2025
From: CERUS CORPORATION
To: MIDCAP FUNDING IV TRUST
Reel/Frame 072727/0854 →
AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT (TERM LOAN) Recorded Aug 29, 2025
From: CERUS CORPORATION
To: MIDCAP FINANCIAL TRUST
Reel/Frame 072727/0928 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 18, 2024
From: CHURCH, DANIEL; BRINGMANN, PETER; CASTRO, GRACE; LU, THEA; REINHARDT, SHELBY; SANTA MARIA, FELICIA; STASSINOPOULOS, ADONIS
To: CERUS CORPORATION
Reel/Frame 068945/0359 →
Continuity (3)
Division 16236193 · Dec 28, 2018
Provisional Application 62612314 · Dec 29, 2017
Related Publication 20230226232A1 · Jul 20, 2023
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