IP Library › Granted Patent US 12,514,876
Granted Patent B2
US 12,514,876 · App. 17/205,932 · Granted Jan 6, 2026

Cryoprecipitate compositions and methods of preparation thereof

Inventors: Laurence Corash (San Francisco, CA); Elan Weiner (Vernon Hills, IL); Melody Holtan (Martinez, CA); Richard Benjamin (Potomac, MD)
Assignee: Cerus Corporation
A61K35/16A61J1/18A61K9/0019A61K38/363A61K38/37A61K41/17A61L2/0047A61M1/0272A61M1/0281A61K2035/124A61L2/07A61L2/081A61L2/087A61L2202/181A61L2202/22A61L2202/23A61M1/3683
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Quick Facts
Patent No.
US 12,514,876
App. No.
17/205,932
Granted
Jan 6, 2026
Kind
B2
Abstract

Provided herein are compositions and kits including a pathogen-inactivated cryoprecipitate suitable for infusion into a subject at least 1 day after thawing. The methods are useful in the efficient preparation of cryoprecipitates with desirable characteristics, including pathogen-inactivated cryoprecipitates that are suitable for infusion into a subject at least 1 day after thawing.

Claims (72)

1 . A method of infusing a cryoprecipitate into a subject, comprising infusing into the subject a composition comprising a cryoprecipitate at least 1 day after thawing the composition comprising the cryoprecipitate, wherein the composition comprising the cryoprecipitate is pathogen-inactivated.

2 . The method of claim 1 , wherein the method comprises infusing the composition into the subject at least 3 days after thawing the composition.

3 . The method of claim 1 , wherein the method comprises infusing the composition into the subject at least 5 days after thawing the composition.

4 . The method of claim 1 , wherein the method comprises infusing the composition into the subject within 7 days after thawing the composition.

5 . The method of claim 1 , wherein the subject suffers from bleeding.

6 . The method of claim 5 , wherein the bleeding is associated with fibrinogen deficiency.

7 . The method of claim 5 , wherein the bleeding is from massive hemorrhage.

8 . The method of claim 1 , wherein the subject suffers from von Willebrand disease.

9 . The method of claim 1 , wherein the composition comprising the cryoprecipitate is stored for at least 1 day at between 2° C. and 25° C. after thawing and prior to the infusion.

10 . The method of claim 1 , wherein the composition comprising the cryoprecipitate is stored for at least 1 day at between 20° C. and 25° C. after thawing and prior to the infusion.

11 . The method of claim 1 , wherein the composition comprising the cryoprecipitate is stored for at least 1 day at room temperature after thawing and prior to the infusion.

12 . The method of claim 1 , wherein the method does not comprise determining a level of factor VIII in the composition.

13 . The method of claim 12 , wherein the method does not comprise determining a level of factor VIII in the composition by determining the level of factor VIII in the composition itself or by determining the level of factor VIII in one or more cryoprecipitate sample(s) held to be representative of the composition.

14 . The method of claim 1 , wherein the composition comprises cryoprecipitate that is prepared from pathogen inactivated apheresis collected plasma.

15 . The method of claim 1 , wherein the composition comprises cryoprecipitate that is prepared from pathogen inactivated whole-blood derived plasma.

16 . The method of claim 1 , wherein the composition comprises cryoprecipitate that is prepared from plasma frozen within 24 hours of donation.

17 . The method of claim 1 , wherein the composition comprises cryoprecipitate prepared from at least about 550 mL and less than about 650 mL of pathogen-inactivated plasma.

18 . The method of claim 1 , wherein the composition comprises a first cryoprecipitate prepared from at least about 550 mL and less than about 650 mL of pathogen-inactivated plasma and a second cryoprecipitate prepared from at least about 550 mL and less than about 650 mL of pathogen-inactivated plasma, wherein the first and the second cryoprecipitates are combined prior to the infusion.

19 . The method of claim 18 , wherein the composition further comprises a third cryoprecipitate prepared from at least about 550 mL and less than about 650 mL of pathogen-inactivated plasma, wherein the first, second, and third cryoprecipitates are combined prior to the infusion.

20 . The method of claim 1 , wherein the composition comprises at least three cryoprecipitates that are combined prior to the infusion.

21 . The method of claim 1 , wherein the composition comprises cryoprecipitate prepared from plasma obtained from 2-6 donors.

22 . The method of claim 1 , wherein the composition comprises at least 600 mg of fibrinogen.

23 . The method of claim 22 , wherein the composition comprises at least 750 mg of fibrinogen.

24 . The method of claim 22 , wherein the composition comprises at least 1500 mg of fibrinogen.

25 . The method of claim 1 , wherein the cryoprecipitate has been pathogen-inactivated by photochemical inactivation.

26 . The method of claim 25 , wherein the cryoprecipitate has been pathogen-inactivated by photochemical inactivation with a psoralen.

27 . The method of claim 26 , wherein the psoralen is amotosalen.

28 . The method of claim 1 , wherein the cryoprecipitate is prepared from plasma that has been pathogen-inactivated in a first container suitable for photochemical inactivation of the plasma under sterile conditions;

wherein the first container is coupled to a compound absorption device (CAD) such that the pathogen-inactivated plasma can be transferred from the first container to the CAD under sterile conditions;

wherein the CAD is coupled to one or more second containers, each of which is coupled to the CAD such that the pathogen-inactivated plasma can be transferred from the CAD to the one or more second containers under sterile conditions; and

wherein the cryoprecipitate is contained within a third container configured to be coupled to one or more second containers, such that the pathogen-inactivated plasma can be transferred from the CAD to the one or more second containers to the third container under sterile conditions, wherein the third container is suitable for freezing the pathogen-inactivated plasma followed by thawing of the pathogen-inactivated plasma under conditions that provide for the formation of the cryoprecipitate.

29 . The method of claim 1 , wherein the composition is contained within a kit or container that further comprises a label or instructions indicating that the composition is suitable for use for at least 1 day after thawing.

30 . The method of claim 1 , wherein the composition is contained within a kit or container that further comprises a label or instructions indicating that the composition is suitable for use for up to about 7 days after thawing.

31 . The method of claim 1 , wherein the composition is contained within a kit or container that further comprises a label or instructions indicating that the composition is suitable for use for up to 5 days after thawing.

32 . The method of claim 1 , wherein the composition further comprises plasma of a volume from about 30 mL to about 150 mL.

33 . A method of infusing a cryoprecipitate into a subject, comprising infusing into the subject a cryoprecipitate produced by a method that comprises:

a) preparing a cryoprecipitate from pathogen-inactivated plasma;

b) freezing the cryoprecipitate; and

c) thawing the frozen cryoprecipitate;

wherein the cryoprecipitate is stored for at least 1 day at room temperature after thawing and prior to the infusion.

34 . The method of claim 33 , wherein the resulting cryoprecipitate of step c) is stored for at least 3 days at room temperature after thawing and prior to the infusion.

35 . The method of claim 33 , wherein the resulting cryoprecipitate of step c) is stored for at least 5 days at room temperature after thawing and prior to the infusion.

36 . The method of claim 33 , wherein the resulting cryoprecipitate of step c) is infused into the subject within 7 days after thawing.

37 . The method of claim 33 , wherein the subject suffers from bleeding.

38 . The method of claim 37 , wherein the bleeding is associated with fibrinogen deficiency.

39 . The method of claim 37 , wherein the bleeding is from massive hemorrhage.

40 . The method of claim 33 , wherein the subject suffers from von Willebrand disease.

41 . The method of claim 33 , wherein the resulting cryoprecipitate of step c) comprises at least 600 mg of fibrinogen.

42 . The method of claim 41 , wherein the resulting cryoprecipitate of step c) comprises at least 750 mg of fibrinogen.

43 . The method of claim 41 , wherein the resulting cryoprecipitate of step c) comprises at least 1500 mg of fibrinogen.

44 . The method of claim 33 , wherein the cryoprecipitate is prepared from at least about 550 mL and less than about 650 mL of pathogen-inactivated plasma.

45 . The method of claim 33 , further comprising, prior to step b), combining a first cryoprecipitate prepared from at least about 550 mL and less than about 650 mL of pathogen-inactivated plasma and a second cryoprecipitate prepared from at least about 550 mL and less than about 650 mL of pathogen-inactivated plasma.

46 . The method of claim 45 , further comprising, prior to step b), combining a third cryoprecipitate prepared from at least about 550 mL and less than about 650 mL of pathogen-inactivated plasma with the first and second cryoprecipitates.

47 . The method of claim 33 , wherein the resulting cryoprecipitate of step c) comprises 80-480 IU of factor VIII.

48 . The method of claim 33 , wherein the method does not comprise determining a level of factor VIII in the cryoprecipitate composition.

49 . The method of claim 48 , wherein the method does not comprise determining a level of factor VIII in the cryoprecipitate by determining the level of factor VIII in the cryoprecipitate itself or by determining the level of factor VIII in one or more cryoprecipitate sample(s) held to be representative of the cryoprecipitate.

50 . The method of claim 33 , wherein the plasma has been pathogen-inactivated by photochemical inactivation.

51 . The method of claim 50 , wherein the plasma has been pathogen-inactivated by photochemical inactivation with a psoralen.

52 . The method of claim 51 , wherein the psoralen is amotosalen.

53 . The method of claim 33 , wherein the cryoprecipitate is prepared from plasma that has been pathogen-inactivated in a first container suitable for photochemical inactivation of the plasma under sterile conditions;

wherein the first container is coupled to a compound absorption device (CAD) such that the pathogen-inactivated plasma can be transferred from the first container to the CAD under sterile conditions; and

wherein the cryoprecipitate is frozen and thawed in steps b) and c) within one or more second containers, each of which is coupled to the CAD such that the pathogen-inactivated plasma can be transferred from the CAD to the one or more second containers under sterile conditions, and each of which is suitable for freezing the pathogen-inactivated plasma followed by thawing of the pathogen-inactivated plasma under conditions that provide for the formation of the cryoprecipitate.

54 . The method of claim 33 , wherein the cryoprecipitate is prepared from plasma that has been pathogen-inactivated in a first container suitable for photochemical inactivation of the plasma under sterile conditions;

wherein the first container is coupled to a compound absorption device (CAD) such that the pathogen-inactivated plasma can be transferred from the first container to the CAD under sterile conditions; and

wherein the cryoprecipitate is frozen and thawed in steps b) and c) within a third container configured to be coupled to one or more second containers, such that the pathogen-inactivated plasma can be transferred from the CAD to the one or more second containers to the third container under sterile conditions, wherein the third container is suitable for freezing the pathogen-inactivated plasma followed by thawing of the pathogen-inactivated plasma under conditions that provide for the formation of the cryoprecipitate.

55 . The method of claim 33 , further comprising combining a first and a second cryoprecipitate prior to freezing in step b).

56 . The method of claim 55 , wherein the method comprises combining at least three cryoprecipitates prior to freezing in step b).

57 . The method of claim 33 , wherein the cryoprecipitate is prepared from pathogen inactivated apheresis collected plasma.

58 . The method of claim 33 , wherein the cryoprecipitate is prepared from pathogen inactivated whole-blood derived plasma.

59 . The method of claim 33 , wherein the cryoprecipitate is prepared from plasma frozen within 24 hours of donation.

60 . The method of claim 33 , wherein the resulting cryoprecipitate of step c) further comprises plasma of a volume from about 30 mL to about 150 mL.

61 . The method of claim 33 , wherein the cryoprecipitate is stored for at least 1 day at between 20° C. and 24° C. after thawing and prior to the infusion.

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 Jul 14, 2021
From: CORASH, LAURENCE; WEINER, ELAN; HOLTAN, MELODY; BENJAMIN, RICHARD
To: CERUS CORPORATION
Reel/Frame 056856/0275 →
Continuity (4)
Division 15192900 · Jun 24, 2016
Provisional Application 62245927 · Oct 23, 2015
Provisional Application 62185519 · Jun 26, 2015
Related Publication 20210260114A1 · Aug 26, 2021
References Cited (290)
US 5098372A · Jonsson · 1992 [cited by applicant]
US 5167656A · Lynn · 1992 [cited by applicant]
US 5288605A · Lin et al. · 1994 [cited by applicant]
US 5399719A · Wollowitz et al. · 1995 [cited by applicant]
US 5405343A · Mohr · 1995 [cited by applicant]
US 5459030A · Lin et al. · 1995 [cited by applicant]
US 5482828A · Lin et al. · 1996 [cited by applicant]
US 5556993A · Wollowitz · 1996 [cited by applicant]
US 5559250A · Cook · 1996 [cited by applicant]
US 5578736A · Wollowitz · 1996 [cited by applicant]
US 5585503A · Wollowitz · 1996 [cited by applicant]
US 5589462A · Patat · 1996 [cited by applicant]
US 5593823A · Wollowitz et al. · 1997 [cited by applicant]
US 5618662A · Lin et al. · 1997 [cited by applicant]
US 5625079A · Wollowitz et al. · 1997 [cited by applicant]
US 5654443A · Wollowitz · 1997 [cited by applicant]
US 5691132A · Wollowitz et al. · 1997 [cited by applicant]
US 5712085A · Wollowitz · 1998 [cited by applicant]
US 5871900A · Wollowitz · 1999 [cited by applicant]
US 5908742A · Lin et al. · 1999 [cited by applicant]
US 5965349A · Lin · 1999 [cited by applicant]
US 5972593A · Wollowitz · 1999 [cited by applicant]
US 6004741A · Wollowitz · 1999 [cited by applicant]
US 6004742A · Wollowitz · 1999 [cited by applicant]
US 6017691A · Wollowitz et al. · 2000 [cited by applicant]
US 6093725A · Cook et al. · 2000 [cited by applicant]
US 6099734A · Mclarty · 2000 [cited by applicant]
US 6133460A · Wollowitz et al. · 2000 [cited by applicant]
US 6143490A · Cook et al. · 2000 [cited by applicant]
US 6171777B1 · Cook · 2001 [cited by applicant]
US 6177441B1 · Cook et al. · 2001 [cited by applicant]
US 6194139B1 · Wollowitz · 2001 [cited by applicant]
US 6218100B1 · Wollowitz · 2001 [cited by applicant]
US 6251580B1 · Lin · 2001 [cited by applicant]
US 6270952B1 · Cook et al. · 2001 [cited by applicant]
US 6281225B1 · Hearst et al. · 2001 [cited by applicant]
US 6364864B1 · Mohiuddin · 2002 [cited by applicant]
US 6410219B1 · Cook et al. · 2002 [cited by applicant]
US 6420570B1 · Wollowitz · 2002 [cited by applicant]
US 6433343B1 · Cimino et al. · 2002 [cited by applicant]
US 6455286B1 · Wollowitz · 2002 [cited by applicant]
US 6469052B2 · Wollowitz · 2002 [cited by applicant]
US 6503699B1 · Wollowitz et al. · 2003 [cited by applicant]
US 6514987B1 · Cook et al. · 2003 [cited by applicant]
US 6544727B1 · Hei · 2003 [cited by applicant]
US 6548242B2 · Horowitz et al. · 2003 [cited by applicant]
US 6565802B1 · Hanley · 2003 [cited by applicant]
US 6586749B2 · Cimino · 2003 [cited by applicant]
US 6686480B2 · Wollowitz · 2004 [cited by applicant]
US 6709810B2 · Cook · 2004 [cited by applicant]
US 6936413B1 · Bischof · 2005 [cited by applicant]
US 6949753B2 · Cimino · 2005 [cited by applicant]
US 6951713B2 · Hei et al. · 2005 [cited by applicant]
US 7025877B1 · De Gheldere · 2006 [cited by applicant]
US 7037642B2 · Hei et al. · 2006 [cited by applicant]
US 7068361B2 · Cimino · 2006 [cited by applicant]
US 7105093B2 · De Gheldere · 2006 [cited by applicant]
US 7264608B2 · Bischof · 2007 [cited by applicant]
US 7293985B2 · Cook · 2007 [cited by applicant]
US 7425304B2 · De Gheldere · 2008 [cited by applicant]
US 7445756B2 · Moore · 2008 [cited by applicant]
US 7534348B2 · Reitz · 2009 [cited by applicant]
US 7611831B2 · Hei · 2009 [cited by applicant]
US 7655392B2 · Stassinopoulos · 2010 [cited by applicant]
US 8296071B2 · Edrich et al. · 2012 [cited by applicant]
US 8439889B2 · Sano · 2013 [cited by applicant]
US 8900805B2 · Mufti et al. · 2014 [cited by applicant]
US 9259525B2 · Hei · 2016 [cited by applicant]
US 9713627B2 · Mufti · 2017 [cited by applicant]
US 10357516B2 · Mufti · 2019 [cited by applicant]
US 10799533B2 · Corash · 2020 [cited by applicant]
US 11096963B2 · Corash et al. · 2021 [cited by applicant]
US 20010009756A1 · Hei · 2001 [cited by applicant]
US 20010018179A1 · Hei · 2001 [cited by applicant]
US 20020006393A1 · Wollowitz · 2002 [cited by applicant]
US 20020028432A1 · Cook · 2002 [cited by applicant]
US 20020042043A1 · Stassinopoulos · 2002 [cited by applicant]
US 20020115585A1 · Hei · 2002 [cited by applicant]
US 20020192632A1 · Hei · 2002 [cited by applicant]
US 20030062483A1 · Cimino · 2003 [cited by applicant]
US 20030105339A1 · Wollowitz · 2003 [cited by applicant]
US 20030113704A1 · Stassinopoulos · 2003 [cited by applicant]
US 20030185804A1 · Wollowitz et al. · 2003 [cited by applicant]
US 20030207247A1 · Stassinopoulos et al. · 2003 [cited by applicant]
US 20040021809A1 · Sumiyoshi et al. · 2004 [cited by applicant]
US 20040029897A1 · Cook · 2004 [cited by applicant]
US 20040180321A1 · Cook · 2004 [cited by applicant]
US 20040185544A9 · Hei · 2004 [cited by applicant]
US 20040185553A9 · Hei · 2004 [cited by applicant]
US 20040197343A1 · Dubensky et al. · 2004 [cited by applicant]
US 20040228877A1 · Dubensky et al. · 2004 [cited by applicant]
US 20050142542A1 · Hei · 2005 [cited by applicant]
US 20050175625A1 · Jaffee et al. · 2005 [cited by applicant]
US 20050202395A1 · Edrich et al. · 2005 [cited by applicant]
US 20050249748A1 · Dubensky et al. · 2005 [cited by applicant]
US 20050281783A1 · Kinch et al. · 2005 [cited by applicant]
US 20060009399A1 · Davis · 2006 [cited by applicant]
US 20060115466A1 · Stassinopoulos · 2006 [cited by applicant]
US 20070031457A1 · Dubensky et al. · 2007 [cited by applicant]
US 20070190029A1 · Pardoll et al. · 2007 [cited by applicant]
US 20070190063A1 · Bahjat et al. · 2007 [cited by applicant]
US 20070207170A1 · Dubensky et al. · 2007 [cited by applicant]
US 20070207171A1 · Dubensky et al. · 2007 [cited by applicant]
US 20100133160A1 · Hei · 2010 [cited by applicant]
US 20100310524A1 · Bechor et al. · 2010 [cited by applicant]
US 20110033554A1 · Burnouf · 2011 [cited by applicant]
US 20110286987A1 · Mufti · 2011 [cited by applicant]
US 20130143198A1 · Sailliol · 2013 [cited by applicant]
US 20130274444A1 · Schulz et al. · 2013 [cited by applicant]
US 20150157665A1 · Mufti · 2015 [cited by applicant]
US 20160354533A1 · Hei · 2016 [cited by applicant]
US 20170027986A1 · Corash et al. · 2017 [cited by applicant]
US 20170202882A1 · Vermeij · 2017 [cited by applicant]
US 20170304363A1 · Corash · 2017 [cited by applicant]
US 20180008639A1 · Mufti · 2018 [cited by applicant]
US 20180185484A1 · Greenman et al. · 2018 [cited by applicant]
US 20180289873A1 · David · 2018 [cited by applicant]
US 20180318348A1 · Corash et al. · 2018 [cited by applicant]
US 20190085289A1 · Greenman · 2019 [cited by applicant]
US 20190209718A1 · Church · 2019 [cited by applicant]
US 20210322479A1 · Vermeij · 2021 [cited by applicant]
US 20220031917A1 · Cahyadi et al. · 2022 [cited by applicant]
US 20220118136A1 · Church et al. · 2022 [cited by applicant]
US 20240173351A1 · Corash · 2024 [cited by applicant]
EP 0534178A2 · 1993 [cited by applicant]
GB 1516698A · 1978 [cited by applicant]
WO 199300005A1 · 1993 [cited by applicant]
WO 199305822A1 · 1993 [cited by applicant]
WO 199317553A1 · 1993 [cited by applicant]
WO 199403054A1 · 1994 [cited by applicant]
WO 199427433A1 · 1994 [cited by applicant]
WO 199500141A1 · 1995 [cited by applicant]
WO 199512973A1 · 1995 [cited by applicant]
WO 199519705A1 · 1995 [cited by applicant]
WO 199608965A1 · 1996 [cited by applicant]
WO 199614737A1 · 1996 [cited by applicant]
WO 199614739A1 · 1996 [cited by applicant]
WO 199614740A1 · 1996 [cited by applicant]
WO 199639815A1 · 1996 [cited by applicant]
WO 199639818A1 · 1996 [cited by applicant]
WO 199639820A1 · 1996 [cited by applicant]
WO 199640857A1 · 1996 [cited by applicant]
WO 199721346A1 · 1997 [cited by applicant]
WO 199818908A1 · 1998 [cited by applicant]
WO 199830327A1 · 1998 [cited by applicant]
WO 199830545A1 · 1998 [cited by applicant]
WO 199903976A2 · 1999 [cited by applicant]
WO 199903976A3 · 1999 [cited by applicant]
WO 199926476A1 · 1999 [cited by applicant]
WO 199934839A1 · 1999 [cited by applicant]
WO 199934914A1 · 1999 [cited by applicant]
WO 199934915A1 · 1999 [cited by applicant]
WO 199963981A2 · 1999 [cited by applicant]
WO 199963981A3 · 2000 [cited by applicant]
WO 200191775A2 · 2001 [cited by applicant]
WO 200191775A3 · 2002 [cited by applicant]
WO 2003047650A2 · 2003 [cited by applicant]
WO 2003049784A2 · 2003 [cited by applicant]
WO 2003049784A3 · 2003 [cited by applicant]
WO 2003061379A2 · 2003 [cited by applicant]
WO 2003065787A2 · 2003 [cited by applicant]
WO 2003078023A1 · 2003 [cited by applicant]
WO 2003061379A3 · 2003 [cited by applicant]
WO 2003090794A1 · 2003 [cited by applicant]
WO 2003065787A3 · 2003 [cited by applicant]
WO 2003047650A3 · 2004 [cited by applicant]
WO 2004049914A2 · 2004 [cited by applicant]
WO 2004050029A2 · 2004 [cited by applicant]
WO 2004050848A2 · 2004 [cited by applicant]
WO 2004050897A2 · 2004 [cited by applicant]
WO 2004050897A3 · 2004 [cited by applicant]
WO 2004050029A3 · 2004 [cited by applicant]
WO 2004084936A2 · 2004 [cited by applicant]
WO 2004050848A3 · 2004 [cited by applicant]
WO 2004110481A2 · 2004 [cited by applicant]
WO 2004049914A3 · 2005 [cited by applicant]
WO 2005009463A2 · 2005 [cited by applicant]
WO 2004110481A3 · 2005 [cited by applicant]
WO 2005037233A2 · 2005 [cited by applicant]
WO 2004084936A3 · 2005 [cited by applicant]
WO 2005009463A3 · 2005 [cited by applicant]
WO 2005067460A2 · 2005 [cited by applicant]
WO 2005071088A2 · 2005 [cited by applicant]
WO 2005092372A2 · 2005 [cited by applicant]
WO 2005071088A3 · 2005 [cited by applicant]
WO 2005037233A3 · 2006 [cited by applicant]
WO 2006050328A1 · 2006 [cited by applicant]
WO 2005092372A3 · 2006 [cited by applicant]
WO 2005067460A3 · 2006 [cited by applicant]
WO 2007022511A2 · 2007 [cited by applicant]
WO 2007022520A2 · 2007 [cited by applicant]
WO 2007022520A3 · 2007 [cited by applicant]
WO 2007022511A3 · 2007 [cited by applicant]
WO 2007103225A2 · 2007 [cited by applicant]
WO 2007103261A2 · 2007 [cited by applicant]
WO 2007117371A2 · 2007 [cited by applicant]
WO 2007103225A3 · 2008 [cited by applicant]
WO 2007103261A3 · 2008 [cited by applicant]
WO 2007117371A3 · 2008 [cited by applicant]
WO 2009118331A1 · 2009 [cited by applicant]
WO 2009126786A2 · 2009 [cited by applicant]
WO 2009126786A3 · 2010 [cited by applicant]
WO 2012018484A2 · 2012 [cited by applicant]
WO 2012018484A3 · 2012 [cited by applicant]
WO 2012071135A2 · 2012 [cited by applicant]
WO 2012071135A3 · 2012 [cited by applicant]
WO 2016014854A1 · 2016 [cited by applicant]
WO 2016057965A1 · 2016 [cited by applicant]
WO 2016115535A1 · 2016 [cited by applicant]
WO 2016210374A1 · 2016 [cited by applicant]
WO 2017070619A1 · 2017 [cited by applicant]
WO 2017120545A2 · 2017 [cited by applicant]
WO 2017120545A3 · 2017 [cited by applicant]
WO 2018119462A1 · 2018 [cited by applicant]
WO 2018125994A1 · 2018 [cited by applicant]
WO 2018161020A1 · 2018 [cited by applicant]
Ofosu et al, Thromb Haemost, 2008, 99:851-862. (Year: 2008). [cited by examiner]
Anonymous. (Nov. 17, 2005). “Guideline on the Core SPC for Human Albumin Solution (CPMP/PhVWP/BPWG/2231/99 rev. 2),” Committee for Medicinal Products for Human Use (CHMP) pp. 1-10. [cited by applicant]
Asselta, R. et al. (2006). “The Molecular Basis of Quantitative Fibrinogen Disorders,” Journal of Thrombosis and Haemostasis 4:2115-2129. [cited by applicant]
Aznar, J.A. et al. (Jan. 1, 2000). “Influence of Methylene Blue Photoinactivation Treatment on Coagulation Factors from Fresh Frozen Plasma, Cryoprecipitates and Cryosupernatants,” Vox Sanguinis 78:156-160. [cited by applicant]
Backholer, L. et al. (2016). “Paired Comparison of Methylene Blue- and Amotosalen-Treated Plasma and Cryoprecipitate,” VoxSanguinis 10 pages. [cited by applicant]
Bhakta, V. et al. (Feb. 2014, e-pub. May 21, 2013). “Stability of Relevant Plasma Protein Activities in Cryosupernatant Plasma Units During Refrigerated Storage for up to 5 Days Postthaw,” Transfusion 54(2):418-425. [cited by applicant]
Bryant, B. et al. (May 1, 2007). “Pathogen Inactivation: The Definitive Safeguard for the Blood Supply,” pp. 719-733. [cited by applicant]
Burnouf, T. et al. (Feb. 2011). “Pathogen Reduction Technique for Fresh-Frozen Plasma Fraction Minipools Prepared in Disposable Processing Bag Systems,” Transfusion 51:446-447. [cited by applicant]
Burnouf, T. et al. (Nov. 1, 2007). “Preparation and Viral Inactivation of Cryoprecipitate in Blood Banks in Resource-Limited Countries,” ISBT Science Series, 2(2):121-128. [cited by applicant]
Cid, J. et al. (Mar. 2013). “Quantitative and Qualitative Analysis of Coagulation Factors in Cryoprecipitate Prepared from Fresh-Frozen Plasma Inactivated with Amotosalen and Ultraviolet A Light,” Blood Components, 53(3… [cited by applicant]
Circular of Information for the Use of Human Blood and Blood Components (Apr. 2013)., AABB, American Red Cross, American's Blood Centers, and Armed Services Blood Program, 42 pages. [cited by applicant]
Committee for Medicinal Products for Human Use(CHMP) (Nov. 17, 2005). “Guideline on the Core SPC for 7-12 Human Albumin Solution (CPMP/PhVWP/BPWG/2231/99 rev.2),”, 10 pages. [cited by applicant]
Dyck, P.J.et al. (Dec. 1994). “A Plasma Exchange Versus Immune Globulin Infusion Trial in Chronic Inflammatory Demyelinating Polyradiculoneuropathy,” Ann. Neurol. 36(6):838-845. [cited by applicant]
Ekiaby. (Jun. 2013). “Safety and Efficacy of Mini-Pool S/D Cryoprecipitate-Poor-Plasma (S/D-CPP) in Partial Volume Therapeutic Plasma Exchange,” Vox Sanguinus 105(Suppl. 1):257, Abstract P-571. 1 page. [cited by applicant]
El-Ekiaby, M. (2010). “Solvent-Detergent Filtered (S/D-F) Fresh Frozen Plasma and Cryoprecipitate Minipools Prepared in a Newly Designed Integral Disposable Processing Bag System,” Transfusion Medicine 20:48-61. [cited by applicant]
Electronic Code of Federal Regulations (2019). Title 21: Food and Drugs, Section 606.122: Circular of Information, retrieved from https://www.ecfr.gov/cgi-bin/text-idx?SID=36cf34a3930282fa3928d7c7d8de61b0&mc=tr . . . la… [cited by applicant]
Ettinger, A. et al. (2012). “Preparation of Cryoprecipitate From Riboflavin and UV Light-Treated Plasma,” Transfusion and Apheresis Science 46:153-158. [cited by applicant]
European Office Action, dated May 24, 2019, for European Patent Application No. 16738300.9, 5 pages. [cited by applicant]
Extended European Search Report, mailed Oct. 30, 2019, for European Patent Application No. 16858399.5, 19 pages. [cited by applicant]
Garwood, M. et al. (Sep. 2003). “The Effect of Methylene Blue Photoinactivation and Methylene Blue Removal on the Quality of Fresh-Frozen Plasma,” Transfusion 43(9):1238-1247. [cited by applicant]
Green, I. et al. (Jun. 2016). “The Hemostatic Properties of Thawed Pooled Cryoprecipitate Up to 72 Hours,” Blood Components 56:1356-1361. [cited by applicant]
Greenhalgh, D.G. (Jul./Aug. 2007). “Burn Resuscitation,” Journal of Burn Care & Research 28(4):555-565. [cited by applicant]
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components U.S. Department of Health and Human Services, (Aug. 2013), 83 pages. [cited by applicant]
Hayek, S. et al. (Mar. 2011). “Burn Resuscitation: Is It Straightforward or a Challenge?,” Annals of Bums and Fire Disasters XXIV(1):17-21. [cited by applicant]
Herbrecht, R. et al. (2013). “Comparative Effectiveness and Safety of Pathogen Inactivated (Amotosalen-UVA) and Conventional Plasma for Treatment of Auto-Immune Thrombotic Thrombocytopenia Purpura (TTP): A 15-Year Retro… [cited by applicant]
Hornsey, V.S. et al. (Oct. 2009). “Pathogen Reduction of Fresh Plasma Using Riboflavin and Ultraviolet Light: Effects on Plasma Coagulation Proteins,” Transfusion 49(10):2167-2172. [cited by applicant]
Inaba, K. (May 2011). “Freeze-Dried Plasma,” J. Trauma 70(5):S57-S58. [cited by applicant]
Intercept Blood System, “Platelet and Plasma Synergy: A Single System for Two Components,” Cerus Corporation (2006), 3 pages. [cited by applicant]
International Preliminary Report on Patentability issued Dec. 26, 2017, for PCT Application No. PCT/US2016/039428, filed Jun. 24, 2016, 12 pages. [cited by applicant]
International Preliminary Report on Patentability, issued Apr. 28, 2018, for PCT Application No. PCT/US2016/058318, filed Oct. 21, 2016, 13 pages. [cited by applicant]
International Search Report mailed on Dec. 13, 2016, for PCT Application No. PCT/US2016/039428, internationally filed on Jun. 24, 2016, 8 pages. [cited by applicant]
International Search Report, mailed Dec. 20, 2016, for PCT Application No. PCT/US2016/058318, 4 pages. [cited by applicant]
Irsch, J. et al. (2011, e-pub. Jan. 27, 2011). “Pathogen Inactivation of Platelet and Plasma Blood Components for Transfusion Using the INTERCEPT Blood System™,” Transfus. Med. Hemother. 38:19-31. [cited by applicant]
Irsch, J. et al. (2015). “Update on Pathogen Inactivation Treatment of Plasma, With the INTERCEPT Blood System: Current Position on Methodological, Clinical and Regulatory Aspect,” Transfusion and Apheresis Science. 52(… [cited by applicant]
Irsch, J. et al. (Jan. 1, 2010, e-pub. Aug. 30, 2009). “INTERCEPT Plasma: Comparability With Conventional Fresh-Frozen Plasma Based on Coagulation Function—An In Vitro Analysis,” Vox Sanguinis 98(1):47-55. [cited by applicant]
Klein, H.G et al. (Mar. 1, 2005). “Pathogen Inactivation Technology: Cleaning the Blood Supply,” Journal of Internal Medicine, 257(3):224-237. [cited by applicant]
Lozano, M. et al. (Nov. 1, 2013). “Pathogen Inactivation: Coming of Age,” Current Opinion in Hematology, 20(6):540-545. [cited by applicant]
McQuilten, Z.K. et al. (2017, e-pub. Jun. 27, 2017). “Fibrinogen Concentration and Use of Fibrinogen Supplementation With Cryoprecipitate in Patents With Critical Bleeding Receiving Massive Transfusion: A Bi-National Co… [cited by applicant]
Mintz, P.D. et al. (2000). “SP71—Preparation of Cryoprecipitate From Photochemically Treated Fresh Frozen Plasma,” Transfusion 40:63S. [cited by applicant]
Mintz, P.D. et al. (2004). “Therapeutic Plasma Exchange (TPE) for Thrombotic Thrombocytopenia Purpura (TTP) Using Plasma Prepared With Photochemical Treatment (INTERCEPT Plasma),” Abstract 838 Blood 104(11):239a. [cited by applicant]
Mintz, P.D. et al. (May 1, 2006). “Photochemically Treated Fresh Frozen Plasma for Transfusion of Patients with Acquired Coagulopathy of Liver Disease,” 107(9):3753-3760. [cited by applicant]
Mintz, P.D. et al. (Oct. 2006). “A Randomized, Controlled Phase III Trial of Therapeutic Plasma Exchange With Fresh-Frozen Plasma (FFP) Prepared With Amotosalen and Ultraviolet a Light Compared to Untreated FFP in Throm… [cited by applicant]
Mirasol (TerumoBCT) “Pathogen Reduction Technology (PRT) System: A Proven Approach to Improved Blood Safety,” retrieved from https://www.terumobct.com/miraso.pdf, last visited Jun. 18, 2018, 8 pages. [cited by applicant]
Nascimento, B. et al. (Dec. 1, 2014). “Cryoprecipitate Therapy,” British Journal of Anaesthesia 113(6):922-934. [cited by applicant]
New and Emerging Health Technology Report: Technologies for the Inactivation/Reduction of Pathogens in Blood Products, (Jul. 2011) 108 pages. [cited by applicant]
Octaplas, Octapharma, “Highlights of Prescribing Information,” retrieved from https://www.fda.gov/downloads/biologicsbloodvaccines/.../ucm336161.pdf, lasted visited Aug. 22, 2018, 8 pages. [cited by applicant]
O'Shaughnessy, D.F. et al. (May 12, 2004). “Guidelines for the Use of Fresh-Frozen Plasma, Cryoprecipitate and Cryosupernatant,” British Journal of Haematology 126:11-28. [cited by applicant]
Picker, S.M. (Jan. 1, 2013). “Pathogen Reduction Technologies: The Best Solution for Safer Blood?” Journal of Blood Disorders & Transfusion, 3(5), 5 pages. [cited by applicant]
Press Release (Oct. 31, 2018). “Cerus Received FDA Breakthrough Device Designation for Pathogen-Reduced Cryoprecipitate,” retrieved from https://www.marketwatch.com/press-release/cerus-receives-fda-breakthrough-device-d… [cited by applicant]
Prodouz, K.N. et al. (1992). “Effects of Two Viral Inactivation Methods on Platelets: Laser-UV Radiation and Merocyanie 540-Mediated Photoinactivation,” Blood Cells 18(1): 101-116. [cited by applicant]
Radosevich, M. et al. (2010, e-pub. Jul. 29, 2009). “Intravenous Immunoglobulin G: Trends in Production Methods, Quality Control and Quality Assurance,” Vox Sanguinis 98:12-28. [cited by applicant]
Rummler, S. et al. (2013). “SP57—Efficacy and Safety of Pathogen Reduced Plasma in Plasma Therapy in Germany,” Transfusion. 53( up. 2):77A. [cited by applicant]
Sailliol, A. et al. (Jan. 2013). “The Evolving Role of Lyophilized Plasma in Remote Damage Control Resuscitation in the French Armed Forces Health Service,” Transfusion 53(Suppl. 1):65S-71S. [cited by applicant]
Schlenke, P. et al. (2008). “Photochemical Treatment of Plasma With Amotosalen and UVA Light: Process Validation in Three European Blood Centers,” Transfusion 48:697-705, 9 pages. [cited by applicant]
Sheffield, W.P. et al. (2016). “Stability of Coagulation Protein Activities in Single Units of Pools of Cryoprecipitate During Storage at 20-24° C for Up to 24 H,” VoxSanguinis 110:12-19. [cited by applicant]
Singapore Search Report, dated Dec. 12, 2018, for Singapore Patent Application No. 11201710548R, 5 pages. [cited by applicant]
Singapore Written Opinion, dated Dec. 12, 2018, for Singapore Patent Application No. 11201710548R, 9 pages. [cited by applicant]
Singapore Written Opinion, dated Oct. 31, 2019, for Singapore Patent Application No. 11201710548R, 6 pages. [cited by applicant]
Sofer, G. (Aug. 2002). “Virus Inactivation in the 1990s- and Into the 21st Century: Part 2, Red Blood Cells and Platelets,” BioPharm pp. 42-49. [cited by applicant]
Solheim et al. (Jan. 2000). “Viral safety of Solvent/Detergent-Treated Plasma,” Transfusion 40(1):84-90. [cited by applicant]
Spivey, M.A. et al. (1992). “Postfiltration Factor VIII and Fibrinogen Levels in Cryoprecipitate Stored at Room Temperature and at 1 to 6° C,” Transfusion 32(4):340-343. [cited by applicant]
Theraflex (MacoPharma) MB Plasma System, retrieved from https://blood-safety.macopharma.com/category/products/theraflex-mb-plasma-products/product.pdf lasted visited Jun. 18, 2018, 4 pages. [cited by applicant]
U.S. Appl. No. 09/238,355, Greenman, W. et al., filed Jan. 27, 1999. [cited by applicant]
UTMB Health Blood Transfusion Services. “Plasma,” retrieved from internet URL: http://www.utmb.edu/bloodbank/blood-bank-transfusion-services/component-therapy/plasma, last visited Mar. 15, 2019, 1 page. [cited by applicant]
Ward, D.M. (2011, e-pub. Aug. 31, 2011). “Conventional Apheresis Therapies: A Review,” J. Clin. Apheresis 26:230-238. [cited by applicant]
Wiltshire, M. et al. (2013). “Quality of Cryoprecipitate Manufactured From Fresh Frozen Plasma Treated With Methylene Blue or Intercept Pathogen Inactivation Systems,” Vox Sanguinis 105(Suppl. 1):157, Abstract P-264, 1 … [cited by applicant]
Winters, J.L. (2012). “Plasma Exchange: Concepts, Mechanisms, and an Overview of the American Society for Apheresis Guidelines,” Hematology 2012:7-12. [cited by applicant]
Wong, H. et al. (Sep. 22, 2016). “Cryoprecipitate Transfusion: Current Perspectives,” International Journal of Clinical Transfusion Medicine 4:89-97. [cited by applicant]
Written Opinion mailed on Dec. 13, 2016, for PCT Application No. PCT/US2016/039428, filed on Jun. 24, 2016, 11 pages. [cited by applicant]
Written Opinion mailed on Dec. 20, 2016, for PCT Application No. PCT/US2016/058318, filed on Jun. 24, 2016, 12 pages. [cited by applicant]
Yarranton, H. et al. (Sep. 2005). “Coagulation Factor Levels in Cryosupernatant Prepared From Plasma Treated With Amotosalen Hydrochloride (S-59) and Ultraviolet A Light,” Transfusion 45:1453-1458. [cited by applicant]
Yazer, M.H. (2018). “Congress Review: Auditing as a Means of Detecting Waste,” ISBT Science Series 13:29-34. [cited by applicant]
Extended European Search Report, mailed Sep. 10, 2024, for European Patent Application No. 24161270.4, 11 pages. [cited by applicant]
Soundar, E. P. et al. (Sep. 2018, e-pub. Oct. 30, 2017). “Characteristics of Thawed Pooled Cryoprecipitate Stored at Refrigerated Temperature for 24 Hours,” Blood Transfus. 16(5): 443-446. [cited by applicant]