IP Library Granted Patent US 10,842,818
Granted Patent B2
US 10,842,818 · App. 15/327,928 · Granted Nov 24, 2020

Methods for preparing platelet products

Inventor: Johannes Vermeij (Krimpen Aan den Ljssel, NL)
Assignee: Cerus Corporation
A61K35/19C12N5/0644
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Quick Facts
Patent No.
US 10,842,818
App. No.
15/327,928
Granted
Nov 24, 2020
Kind
B2
Abstract

Provided herein are improved processes for preparing and treating platelet products. The methods are useful in the efficient preparation of platelet products with desirable characteristics, including pathogen inactivated platelet products.

Claims (51)

1. A method of preparing a platelet product comprising:

a) identifying a plurality of donated whole blood units according to one or more parameters selected from the group consisting of hematocrit, hemoglobin, donor gender, whole blood volume, packed cell volume and platelet count;

b1) selecting a first subset of whole blood units from the plurality of donated whole blood units within a first specified range of at least two specified ranges for a given parameter of the one or more parameters; and

b2) selecting a second subset of whole blood units from the plurality of donated whole blood units within a second specified range of the at least two specified ranges for the given parameter; and

c) centrifuging the first selected subset of whole blood units and the second selected subset of whole blood units under different centrifugation conditions to provide each whole blood unit having a separated layer of platelet rich plasma; and

d) isolating the separated layer of platelet rich plasma from each whole blood unit to provide platelet rich plasma units.

2. The method of claim 1 , comprising identifying the plurality of donated whole blood units according to two or more said parameters.

3. The method of claim 1 , wherein the at least two specified ranges for a parameter are non-overlapping ranges.

4. The method of claim 1 , wherein the one or more parameters include hematocrit.

5. The method of claim 1 , wherein the one or more parameters include hemoglobin.

6. The method of claim 1 , wherein the one or more parameters include donor gender.

7. The method of claim 1 , wherein the one or more parameters include whole blood volume.

8. The method of claim 1 , wherein each whole blood unit of the selected subset of whole blood units is within the same specified range for two or more of said parameters.

9. The method of claim 8 , wherein the two or more parameters include hematocrit and donor gender.

10. The method of claim 8 , wherein the two or more parameters include either:

donor gender and whole blood volume; or

donor gender and hemoglobin.

11. The method of claim 1 , wherein the specified range for the parameter in the first selected subset of whole blood units or the second selected subset of whole blood units is narrower than the range for the same parameter in the plurality of donated whole blood units.

12. The method of claim 1 , wherein the specified range for the parameter in the first selected subset of whole blood units or the second selected subset of whole blood units is narrower than the range for the same parameter for donated whole blood that meets the acceptance criteria of a regulatory agency or accrediting organization for donated whole blood.

13. The method of claim 12 , wherein the specified range for the parameter in the first selected subset of whole blood units or the second selected subset of whole blood units is narrower than the range for the same parameter for donated whole blood that meets the acceptance criteria of the U.S. Food and Drug Administration (FDA) or the AABB .

14. The method of claim 1 , further comprising:

e) centrifuging the isolated platelet rich plasma units to provide platelet rich plasma units having separated layers of platelet poor plasma and platelet concentrate; and

f) isolating the separated layers of platelet concentrate to provide platelet concentrate units.

15. A method of preparing a platelet product, comprising:

a) identifying a plurality of donated whole blood units according to donor gender;

b) selecting a first subset of whole blood units from the plurality of donated whole blood units, wherein each whole blood unit of the first selected subset is the same donor gender;

c) centrifuging the first selected subset of whole blood units under the same centrifugation conditions to provide each whole blood unit having a separated layer of platelet rich plasma;

d) isolating the separated layer of platelet rich plasma to provide a platelet rich plasma unit;

e) centrifuging the isolated platelet rich plasma unit to provide a platelet rich plasma unit having separated layers of platelet poor plasma and platelet concentrate;

f) isolating the separated layer of platelet concentrate to provide a platelet concentrate unit from the first subset of whole blood units;

g) selecting a second subset of whole blood units from the plurality of donated whole blood units, wherein each whole blood unit of the second selected subset is the same donor gender, and wherein the donor gender of the second selected subset is different from the donor gender of the first selected subset;

h) centrifuging the second selected subset of whole blood units under the same centrifugation conditions to provide each whole blood unit having a separated layer of platelet rich plasma, wherein the centrifugation conditions for the second subset of whole blood units are different from the centrifugation conditions of the first subset of whole blood units;

i) isolating the separated layer of platelet rich plasma to provide a platelet rich plasma unit;

j) centrifuging the isolated platelet rich plasma unit to provide a platelet rich plasma unit having separated layers of platelet poor plasma and platelet concentrate; and

k) isolating the separated layer of platelet concentrate to provide a platelet concentrate unit from the second subset of whole blood units.

16. The method of claim 14 , wherein the isolated platelet concentrate unit further comprises donor plasma.

17. The method of claim 14 , further comprising adding an additive solution to the isolated platelet concentrate unit.

18. The method of claim 14 , further comprising pooling two or more of the isolated platelet concentrate units into one container to provide a pooled platelet product.

19. The method of claim 1 , further comprising treating with a pathogen inactivation compound to inactivate pathogens, if present.

20. The method of claim 19 , wherein the pathogen inactivation compound is a photoactive pathogen inactivation compound selected from the group consisting of a psoralen, an isoalloxazine, an alloxazine, a phthalocyanine, a phenothiazine, a porphyrin, and merocyanine 540.

21. The method of claim 20 , wherein the pathogen inactivation compound is a psoralen.

22. The method of claim 21 , wherein the pathogen inactivation compound is amotosalen.

23. The method of claim 6 , wherein the specified range for donor gender in the selected subset of whole blood units is 100% female donors.

24. The method of claim 6 , wherein the specified range for donor gender in the selected subset of whole blood units is 100% male donors.

25. The method of claim 14 , wherein the isolated platelet concentrate unit comprises about 0.1×10 11 to about 2.2×10 11 platelets.

26. The method of claim 14 , wherein the isolated platelet concentrate unit has a volume of about 45-80 mL.

27. The method of claim 14 , wherein the isolated platelet concentrate unit has a volume of about 15-45 mL.

28. The method of claim 14 , wherein the isolated platelet concentrate unit has a volume of less than about 5 mL.

29. The method of claim 16 , wherein the donor plasma is an amount of remaining plasma from the platelet rich plasma unit.

30. The method of claim 18 , comprising pooling 3-6 isolated platelet concentrate units.

31. The method of claim 18 , comprising pooling 7-10 isolated platelet concentrate units.

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 Aug 4, 2020
From: VERMEIJ, JOHANNES
To: CERUS CORPORATION
Reel/Frame 053397/0631 →
Continuity (4)
Provisional Application 62028245 · Jul 23, 2014
Provisional Application 62068528 · Oct 24, 2014
Provisional Application 62185449 · Jun 26, 2015
Related Publication 20170202882A1 · Jul 20, 2017
Cited By (5)
US 12,214,092 US 12,282,015 US 12,343,436 US 12,514,944 US 12,558,442