CN1893960B - 从非高加索人血浆生产的普遍适用的病毒灭活血浆 - Google Patents
从非高加索人血浆生产的普遍适用的病毒灭活血浆 Download PDFInfo
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Abstract
由10％或更多属于非高加索人群的供者收集的人用血浆，血浆可以如此获得：混合A血型和B血型、任选地AB型的血或血浆，而不混合相当大量的O血型的血或血浆，其特征在于，4-8份血或血浆来自具有A血型的供者，超过3份-7份血或血浆来自具有B血型的供者，0-2份血或血浆来自具有AB血型的供者。
Description
技术领域
本发明涉及从基本上是非高加索人的供者收集的血浆、包含本发明血浆的药物制剂和本发明的血浆用于制造药物的用途。
背景技术
Karl Landsteiner发现了人类血液中的血型和固有的个体间差异。ABO血型系统包含4种主要表现型：O、A、B和AB，表现型由9号染色体上ABO基因座的共显性等位基因来控制。
在血栓性血小板减少性紫癜和重复性大体积血浆交换中，输ABO一致的或相容的血浆，例如特定血型的FFP可以有效的并且通常良好耐受的治疗各种类型复合或分离的凝血因子缺乏。然而输血浆原则上给接受者带来不利事件的一些风险，包括传播传染性和非传染性疾病。
非传染性不利事件通常在例如输血的供者红细胞和接受者抗体之间的免疫不相容性导致输入细胞的加速破坏时发生。根据Landsteiner定律，如果红细胞中不存在相应的抗原则任何人类个体的血浆中含相应抗体。例如，向B型患者输A型供者血浆，来自供者血浆的抗-B抗体将与患者红细胞反应并导致其破坏。相似地，来自B型供者的血浆包含抗-A抗体，它与A型患者是不相容的；来自O型供者的血浆包含抗-A和抗-B抗体，它与具有A、B或AB血型的患者不相容。因此，血型必须匹配以避免基于ABO不相容性的反应。
除了非传染性不利事件，许多传染性因子，包括病毒、细菌和寄生虫，可以通过输血传播。公知的病毒包括甲型肝炎病毒(HAV)、乙型肝炎病毒(HBV)、丙型肝炎病毒(HCV)、1型和2型人免疫缺陷病毒(HIV-1/2)和人细小病毒(PV)。通过引入供者筛选和新测试方法，尤其是通过引入病毒灭活和/或病毒去除步骤，将传播病毒感染的风险降到最低限度。这些步骤包括通过溶剂/去污剂处理(EP-A-0 131740)、照射和巴氏消毒灭活病毒，或通过纳滤去除病毒。
溶剂/去污剂处理的具有特定血型的人类血浆，例如A、B、O或AB型Octaplas(Octapharma AG Switzerland)，已经被开发出来作为FFP的替代物以防止病毒传播。
原则上普遍适用的血浆可以通过只使用AB型血浆获得，其中即不包含抗-A抗体也不包含抗-B抗体(IgM和IgG)，因此与任何患者相容，而与其血型无关。然而，AB型供者的频率(4％)是有限的。如果来自B型和A型供者的抗-A和/或抗-B抗体分别被去除和/或通过与不同血型的血浆的最佳混合而被中和，就得到适于万能输血的血浆。已经描述过抗体的这种中和作用(WO-A-99/07390)，包括混合6-10份A血型的血或血浆、1-3份B血型的血或血浆、和任选地0-1.5份AB血型的血或血浆，而不混入相当大量的来自O血型的血或血浆。
原则上所有人种共享同一血液系统，尽管四种主要ABO血型的频率在全世界的人群中不同。测定抗-A和抗-B抗体的效价，出人意料的发现不同的种族之间ABO血型的频率和血型特异性抗体的效价均不同。高加索人中，通常来说，B型和O型受检者中抗-A的效价趋向于比A型和O型受检者中抗-B的效价高。相反地，非高加索人背景的人中，例如非裔美洲人、西班牙人或土著美洲人供者中，抗-B与抗-A的效价几乎一样高。因此，将高加索人的血浆与相当部分的来自非高加索人的血浆按照前面提到的比率混合，没有发现血型特异性抗体的最佳中和作用。例如，通过混合7份A血型的血浆和3份B血型的血浆，其中相当一部分收集自非高加索人供者，在血浆收集混合物中发现IgM和IgG类型的高抗-B效价。
发明内容
本发明的一个目的是开发进一步适用的病毒灭活血浆，所述血浆由不同血型血浆的最佳混合制得，不同血型的血浆来自来源于高加索人的血或血浆和部分非高加索人供者的血或血浆，如非裔美洲人、西班牙人和土著美洲人起源的供者，以辅助混合物中血型特异性抗体的最佳中和。
这个目的通过从10％或更多属于非高加索人的供者收集的人用血浆来解决，血浆可以如此获得：混合A血型和B血型、任选地AB型的血或血浆，而不混合相当大量的O血型的血或血浆，其中包含：
-4-8份具有A血型的供者的血或血浆，
-超过3份-7份具有B血型的供者的血或血浆，
-0-2份具有AB血型的供者的血或血浆。
O血型组分可以存在于本发明的血浆中，只要这些组分不引入基本超过A血型或B血型抗原总浓度的抗体即可。
本发明的血浆产品中，通过不同血型的最佳混合，ABO血型特异性抗体基本上被游离血型物质中和，因此，该血浆可以不管患者的ABO血型进行输血。因此，本发明的血浆进一步降低了与输血相关的感染和与ABO不相容性相关的死亡的风险。
本发明的另一个实施方案中，血浆混合物由下列组成：
-5-6份来自具有A血型的供者的血或血浆，
-4-5份来自具有B血型的供者的血或血浆，
-0-1份来自具有AB血型的供者的血或血浆，和
-基本上没有来自O血型的供者的血或血浆。
至于本发明血浆的ABO血型特异性抗体的效价，具体而言，抗-A和抗-B IgM抗体低于16，抗-A和抗-B IgG抗体低于64。本发明的另一种血浆混合物中，抗-A和抗-B IgM抗体的效价低于8，抗-A和抗-B IgG抗体的效价低于32，使用技术人员已知的和在欧洲药典中描述的测试法(间接库姆斯氏实验)。
优选地，本发明的血浆通过EP-A-131740的方法灭活，已知的是溶剂/去污剂处理、照射、巴氏消毒和/或纳滤。典型的溶剂/去污剂处理例如是使用去污剂如氧乙烯化多酚如Triton-X-100、和/或脂肪酸的聚氧化乙烯衍生物例如吐温80和磷酸三丁酯(TNBP)或它们的组合。还可用于病毒灭活的是饱和和不饱和的、中到长链脂肪酸或其盐，优选辛酸或其盐。其它的方法是照射、巴氏消毒或纳滤。本领域的技术人员已知所有这些方法。
优选地，冷冻或冻干本发明的血浆。
本发明的血浆显示与新鲜冷冻血浆相当的凝集活性。
本发明通过下面的实施例进一步举例说明。
实施例1
190kg A血型的新鲜冷冻血浆，156kg B血型的血浆和34kg AB血型的血浆，所有血浆的供者中有相当一部分是非高加索人，在37℃下解冻后混合。得到的血浆混合物通过使用溶剂/去污剂方法灭活病毒。去除病毒灭活试剂并冻干之后，测定游离的IgM和IgG型的抗-A和抗-B抗体的量。IgM型抗-A和抗-B抗体的效价低于8，IgG型抗-A和抗-B抗体的效价低于32。
实施例2
205kg A血型的新鲜冷冻血浆和137kg B血型的血浆，所有血浆的供者中有相当一部分是非高加索人，在37℃下解冻后混合。使用和实施例1中同样的步骤。IgM型抗-A和抗-B抗体的效价低于8，IgG型抗-A和抗-B抗体的效价低于32。
Claims (11)
1.从10％或更多属于非高加索人群的供者收集的人用血浆，所述血浆可以如此获得：
混合A血型和B血型、任选地AB血型的血或血浆，而不混合O血型的血或血浆，其特征在于
-5-6份血或血浆来自具有A血型的供者，
-4份-5份血或血浆来自具有B血型的供者，
-0-1份血或血浆来自具有AB血型的供者。
2.根据权利要求1的血浆，通过任何病毒灭活或病毒去除方法灭活病毒。
3.根据权利要求2的血浆，其中通过溶剂/去污剂处理、照射、巴氏消毒和/或纳滤灭活血浆。
4.根据权利要求3的血浆，其中通过使用去污剂如氧乙烯化多酚如Triton-X-100、和/或脂肪酸的聚氧化乙烯衍生物如Tween80和磷酸三丁酯(TNBP)或其组合进行病毒灭活。
5.根据权利要求3的血浆，通过用长链脂肪酸如辛酸或相应的盐处理灭活病毒。
6.根据前述任一项权利要求的血浆，基本上不含病毒灭活剂。
7.根据前述任一项权利要求的血浆，其中关于ABO血型特异性抗体的效价，抗-A和抗-B IgM抗体低于16，抗-A和抗-B IgG抗体低于64。
8.根据前述任一项权利要求的血浆，其是液体、冷冻、干燥或冻干的形式。
9.一种药物组合物，包含权利要求1-8中任一项的血浆。
10.前述任一项权利要求的血浆用于制造治疗凝血因子缺乏、血栓形成性紫癜的药物和用于重复性大体积血浆交换的用途。
11.制造权利要求1-8中任一项的血浆的方法，包括混合
-4-8份来自具有A血型的供者的血或血浆，
-超过3份-7份来自具有B血型的供者的血或血浆，
-0-2份来自具有AB血型的供者的血或血浆。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP03029359.1 | 2003-12-19 | ||
| EP03029359 | 2003-12-19 | ||
| PCT/EP2004/053608 WO2005058334A1 (en) | 2003-12-19 | 2004-12-20 | A universally applicable virus inactivated blood plasma produced from portions of non-caucasian plasma |
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| Publication Number | Publication Date |
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| CN1893960A CN1893960A (zh) | 2007-01-10 |
| CN1893960B true CN1893960B (zh) | 2012-10-31 |
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| Country | Link |
|---|---|
| US (2) | US20070071829A1 (zh) |
| EP (1) | EP1696940B1 (zh) |
| JP (1) | JP2007514716A (zh) |
| KR (1) | KR101077976B1 (zh) |
| CN (1) | CN1893960B (zh) |
| AT (1) | ATE357242T1 (zh) |
| AU (1) | AU2004298790B2 (zh) |
| BR (1) | BRPI0417680A (zh) |
| CA (1) | CA2550060A1 (zh) |
| CY (1) | CY1106661T1 (zh) |
| DE (1) | DE602004005501T2 (zh) |
| DK (1) | DK1696940T3 (zh) |
| ES (1) | ES2281848T3 (zh) |
| IL (1) | IL175558A0 (zh) |
| NO (1) | NO20062360L (zh) |
| PL (1) | PL1696940T3 (zh) |
| PT (1) | PT1696940E (zh) |
| RS (1) | RS50508B (zh) |
| RU (1) | RU2362571C2 (zh) |
| SI (1) | SI1696940T1 (zh) |
| UA (1) | UA83528C2 (zh) |
| WO (1) | WO2005058334A1 (zh) |
| ZA (1) | ZA200604941B (zh) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1958618A1 (de) | 2007-02-15 | 2008-08-20 | Octapharma AG | Verfahren zur Gefriertrocknung mit optimierter Rekonstitution von Biopolymeren |
| FR2963737B1 (fr) * | 2010-08-16 | 2013-04-05 | Etat Francais Ministere De La Defense Service De Sante Des Armees | Procede de lyophilisation de plasma sanguin |
| EP3093035A1 (en) | 2015-05-13 | 2016-11-16 | Sanofi-Aventis Deutschland GmbH | Injection device for delivery of a liquid medicament |
| CN107496453A (zh) * | 2017-08-13 | 2017-12-22 | 发贵科技（贵州）有限公司 | 一种有病毒灭活功能的血浆抗凝剂 |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1272061A (zh) * | 1997-08-05 | 2000-11-01 | 奥克塔法马有限公司 | 通用血浆 |
| CN1321468A (zh) * | 2001-04-18 | 2001-11-14 | 杜祖鹰 | 无血型冻干血浆及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4664913A (en) * | 1982-05-24 | 1987-05-12 | Xoma Corporation | Method for treating plasma for transfusion |
| US4764369A (en) * | 1983-07-14 | 1988-08-16 | New York Blood Center Inc. | Undenatured virus-free biologically active protein derivatives |
| US5217627A (en) * | 1990-11-06 | 1993-06-08 | Pall Corporation | System and method for processing biological fluid |
| AU667530B2 (en) * | 1992-05-28 | 1996-03-28 | New York Blood Center, Inc., The | Removal of antibodies from blood-derived compositions while retaining coagulation factors |
| US20030133829A1 (en) * | 2001-12-21 | 2003-07-17 | Baxter Healthcare Corporation | Process for inactivating pathogens in a biological material |
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- 2004-12-20 SI SI200430285T patent/SI1696940T1/sl unknown
- 2004-12-20 US US10/580,548 patent/US20070071829A1/en not_active Abandoned
- 2004-12-20 PT PT04804944T patent/PT1696940E/pt unknown
- 2004-12-20 DE DE602004005501T patent/DE602004005501T2/de active Active
- 2004-12-20 WO PCT/EP2004/053608 patent/WO2005058334A1/en active Application Filing
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2006
- 2006-05-11 IL IL175558A patent/IL175558A0/en not_active IP Right Cessation
- 2006-05-23 NO NO20062360A patent/NO20062360L/no not_active Application Discontinuation
- 2006-06-15 ZA ZA200604941A patent/ZA200604941B/en unknown
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2007
- 2007-06-15 CY CY20071100800T patent/CY1106661T1/el unknown
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2010
- 2010-08-24 US US12/805,920 patent/US20110104298A1/en not_active Abandoned
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1272061A (zh) * | 1997-08-05 | 2000-11-01 | 奥克塔法马有限公司 | 通用血浆 |
| CN1321468A (zh) * | 2001-04-18 | 2001-11-14 | 杜祖鹰 | 无血型冻干血浆及其制备方法 |
Also Published As
| Publication number | Publication date |
|---|---|
| EP1696940B1 (en) | 2007-03-21 |
| CA2550060A1 (en) | 2005-06-30 |
| EP1696940A1 (en) | 2006-09-06 |
| BRPI0417680A (pt) | 2007-03-20 |
| PL1696940T3 (pl) | 2007-08-31 |
| DE602004005501T2 (de) | 2007-11-29 |
| RU2362571C2 (ru) | 2009-07-27 |
| US20110104298A1 (en) | 2011-05-05 |
| NO20062360L (no) | 2006-05-23 |
| KR20060126662A (ko) | 2006-12-08 |
| KR101077976B1 (ko) | 2011-10-28 |
| PT1696940E (pt) | 2007-05-31 |
| US20070071829A1 (en) | 2007-03-29 |
| AU2004298790B2 (en) | 2010-04-08 |
| DE602004005501D1 (de) | 2007-05-03 |
| ATE357242T1 (de) | 2007-04-15 |
| WO2005058334A1 (en) | 2005-06-30 |
| IL175558A0 (en) | 2006-09-05 |
| RS50508B (sr) | 2010-03-02 |
| SI1696940T1 (sl) | 2007-08-31 |
| AU2004298790A1 (en) | 2005-06-30 |
| UA83528C2 (uk) | 2008-07-25 |
| DK1696940T3 (da) | 2007-07-30 |
| CN1893960A (zh) | 2007-01-10 |
| JP2007514716A (ja) | 2007-06-07 |
| CY1106661T1 (el) | 2012-05-23 |
| ZA200604941B (en) | 2007-11-28 |
| RU2006126055A (ru) | 2008-01-27 |
| ES2281848T3 (es) | 2007-10-01 |
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