JP6411360B2 - 治療タンパク質の精製方法 - Google Patents
治療タンパク質の精製方法 Download PDFInfo
- Publication number
- JP6411360B2 JP6411360B2 JP2015545601A JP2015545601A JP6411360B2 JP 6411360 B2 JP6411360 B2 JP 6411360B2 JP 2015545601 A JP2015545601 A JP 2015545601A JP 2015545601 A JP2015545601 A JP 2015545601A JP 6411360 B2 JP6411360 B2 JP 6411360B2
- Authority
- JP
- Japan
- Prior art keywords
- fibrinogen
- solution
- vwf
- resin
- factor viii
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
- B01D15/361—Ion-exchange
- B01D15/363—Anion-exchange
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/363—Fibrinogen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/18—Ion-exchange chromatography
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/75—Fibrinogen
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Hematology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Analytical Chemistry (AREA)
- Toxicology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Materials For Medical Uses (AREA)
- Enzymes And Modification Thereof (AREA)
Applications Claiming Priority (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261733761P | 2012-12-05 | 2012-12-05 | |
| US61/733,761 | 2012-12-05 | ||
| EP13153898 | 2013-02-04 | ||
| EP13153898.5 | 2013-02-04 | ||
| US13/803,740 | 2013-03-14 | ||
| US13/803,740 US20140154233A1 (en) | 2012-12-05 | 2013-03-14 | Method of purifying therapeutic proteins |
| AU2013203357A AU2013203357B2 (en) | 2012-12-05 | 2013-04-10 | A method of purifying therapeutic proteins |
| AU2013203357 | 2013-04-10 | ||
| PCT/AU2013/001414 WO2014085861A1 (en) | 2012-12-05 | 2013-12-05 | A method of purifying therapeutic proteins |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018178301A Division JP6836562B2 (ja) | 2012-12-05 | 2018-09-25 | 治療タンパク質の精製方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016501878A JP2016501878A (ja) | 2016-01-21 |
| JP2016501878A5 JP2016501878A5 (enExample) | 2017-01-19 |
| JP6411360B2 true JP6411360B2 (ja) | 2018-10-24 |
Family
ID=47630209
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015545601A Active JP6411360B2 (ja) | 2012-12-05 | 2013-12-05 | 治療タンパク質の精製方法 |
| JP2018178301A Active JP6836562B2 (ja) | 2012-12-05 | 2018-09-25 | 治療タンパク質の精製方法 |
| JP2021016182A Active JP7774384B2 (ja) | 2012-12-05 | 2021-02-04 | 治療タンパク質の精製方法 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018178301A Active JP6836562B2 (ja) | 2012-12-05 | 2018-09-25 | 治療タンパク質の精製方法 |
| JP2021016182A Active JP7774384B2 (ja) | 2012-12-05 | 2021-02-04 | 治療タンパク質の精製方法 |
Country Status (12)
| Country | Link |
|---|---|
| US (5) | US20140154233A1 (enExample) |
| EP (2) | EP3483173A1 (enExample) |
| JP (3) | JP6411360B2 (enExample) |
| KR (2) | KR102403847B1 (enExample) |
| CN (2) | CN109125714B (enExample) |
| AU (2) | AU2013203357B2 (enExample) |
| BR (1) | BR112015012854B1 (enExample) |
| CA (2) | CA3185085A1 (enExample) |
| PL (1) | PL2928905T3 (enExample) |
| RU (1) | RU2685956C2 (enExample) |
| SG (2) | SG11201504372UA (enExample) |
| WO (1) | WO2014085861A1 (enExample) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013135684A1 (en) | 2012-03-13 | 2013-09-19 | Octapharma Ag | Improved process for production of fibrinogen and fibrinogen produced thereby |
| US10188965B2 (en) | 2012-12-05 | 2019-01-29 | Csl Behring Gmbh | Hydrophobic charge induction chromatographic depletion of a protein from a solution |
| US20140154233A1 (en) | 2012-12-05 | 2014-06-05 | Csl Limited | Method of purifying therapeutic proteins |
| GB201506113D0 (en) | 2015-04-10 | 2015-05-27 | Ge Healthcare Bio Sciences Ab | Method for chromatography |
| GB201506117D0 (en) | 2015-04-10 | 2015-05-27 | Ge Healthcare Bio Sciences Ab | Method for chromatography |
| WO2017118910A1 (en) * | 2016-01-07 | 2017-07-13 | Eio Biomedical Ltd | Methods, compositions and kits for reducing tissue adhesions |
| WO2018007767A1 (fr) | 2016-07-06 | 2018-01-11 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Fibrinogène liquide stable |
| IL265102B2 (en) * | 2016-09-01 | 2023-11-01 | Plas Free Ltd | Human Blood-Derived Products Having Decreased Fibrinolytic Activity And Uses Thereof In Hemostatic Disorders |
| KR20200038309A (ko) * | 2017-08-23 | 2020-04-10 | 체에스엘 베링 게엠베하 | 폰 빌레브란트 인자의 바이러스 여과 방법 |
| CN109078628B (zh) * | 2018-08-27 | 2021-06-11 | 西北大学 | 一种以苄胺为配基的高效疏水相互作用色谱介质、制备方法及其在蛋白质复性与纯化的应用 |
| FR3090321B1 (fr) * | 2018-12-21 | 2023-07-14 | Lab Francais Du Fractionnement | Procédé de filtration du fibrinogène |
| US20220380439A1 (en) | 2020-11-09 | 2022-12-01 | Takeda Pharmaceutical Company Limited | Purification of fviii from plasma using silicon oxide adsorption |
| CA3215331A1 (en) | 2021-04-13 | 2022-10-20 | Toshiharu Motokubota | Liquid composition comprising factor viii or factor viii/von willebrand factor complex |
| CN115181178B (zh) * | 2021-09-04 | 2024-04-26 | 广东双林生物制药有限公司 | 一种从冷沉淀中制备人纤维蛋白原的方法 |
| MX2024008243A (es) | 2021-12-30 | 2024-09-04 | Baxter Int | Soluciones de fibrinogeno y trombina para un sellador de fibrina y un kit de sellador de fibrina. |
Family Cites Families (36)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4764369A (en) | 1983-07-14 | 1988-08-16 | New York Blood Center Inc. | Undenatured virus-free biologically active protein derivatives |
| US4540573A (en) | 1983-07-14 | 1985-09-10 | New York Blood Center, Inc. | Undenatured virus-free biologically active protein derivatives |
| FR2632309B1 (fr) | 1988-06-07 | 1990-08-24 | Lille Transfusion Sanguine | Procede de purification par voie chromatographique de proteines, notamment de facteur viii, et les produits obtenus |
| CA2117058A1 (en) * | 1991-09-05 | 1993-03-18 | Daphne C. Tse | Topical fibrinogen complex |
| FR2686883B1 (fr) * | 1992-02-04 | 1994-05-13 | Aquitaine Develop Transf Sanguin | Procede de fabrication de fibrinogene de tres haute purete, fibrinogene de tres haute purete obtenu ainsi qu'une composition pharmaceutique le contenant. |
| CA2195127C (en) * | 1994-07-14 | 2007-06-19 | Ruth Laub | Concentrate of fibrinogene obtained from blood plasma, process and plant for its preparation |
| AU3463495A (en) * | 1994-09-02 | 1996-03-27 | New York Blood Center, Inc., The | Production and secretion of recombinant fibrinogen by yeast |
| US6037457A (en) * | 1997-01-31 | 2000-03-14 | The University Of North Carolina At Chapel Hill | Method for recombinant fibrinogen production |
| FR2772381B1 (fr) | 1997-12-15 | 2001-06-08 | Lab Francais Du Fractionnement | Procede de preparation par filtration d'une solution de facteur viii securisee viralement |
| DE69931645T2 (de) * | 1998-09-24 | 2007-05-16 | Pharming Intellectual Property Bv | Reinigung von fibrinogen aus flüssigkeiten mittels ausfällung und hydrophobischer-interaktion-chromatographie |
| DE60042343D1 (de) * | 1999-12-23 | 2009-07-16 | Csl Ltd | Abtrennung von fibrinogen von plasmaproteasen |
| WO2001046016A1 (en) | 1999-12-23 | 2001-06-28 | Rast Rodger H | System and method for providing individualized dosing |
| DE10022092A1 (de) * | 2000-05-08 | 2001-11-15 | Aventis Behring Gmbh | Stabilisiertes Protein-Präparat und Verfahren zu seiner Herstellung |
| PL205685B1 (pl) * | 2001-05-21 | 2010-05-31 | Omrix Biopharm Sa | Sposób in vitro usuwania lub wyodrębniania plazminogenu lub plazminy w obecności fibrynogenu, stałe podłoże powinowactwa do oczyszczania mieszaniny zawierającej fibrynogen i plazminę i/lub plazminogen oraz krioprecypitat |
| AUPR638801A0 (en) | 2001-07-13 | 2001-08-09 | Life Therapeutics Limited | Factor viii separation |
| JP2005508925A (ja) * | 2001-10-03 | 2005-04-07 | クリストファー ジェイ ウールヴァートン | 貯蔵安定なフィブリノーゲン溶液 |
| AU2002340776A1 (en) * | 2001-10-30 | 2003-05-12 | Novozymes A/S | High throughput isolation of proteins by charge induction chromatography |
| DE10211632A1 (de) | 2002-03-15 | 2003-10-09 | Aventis Behring Gmbh | Verfahren zur Abtrennung von Viren aus einer Proteinlösung durch Nanofiltration |
| JP4319979B2 (ja) * | 2002-04-26 | 2009-08-26 | ジェネンテック・インコーポレーテッド | タンパク質の非アフィニティ精製 |
| GB0216001D0 (en) * | 2002-07-10 | 2002-08-21 | Nat Blood Authority | Process and composition |
| DE10261126A1 (de) | 2002-08-13 | 2004-03-04 | Aventis Behring Gmbh | Lagerungsstabile, flüssige Fibrinogen-Formulierung |
| DE10246125A1 (de) | 2002-10-01 | 2004-04-15 | Aventis Behring Gmbh | Konzentrat eines Faktor VIII:C-haltigen von-Willebrand-Faktors und das dazu gehörige Verfahren |
| ES2214967B1 (es) | 2003-03-06 | 2005-06-16 | Probitas Pharma, S.A | Procedimiento para la eliminacion de virus en soluciones de fibrinogeno y fibrinogeno obtenido por dicho procedimiento. |
| DE102004009400A1 (de) * | 2004-02-24 | 2005-09-08 | Zlb Behring Gmbh | Fibrinogen Reinigung |
| CA2583081A1 (en) * | 2004-06-16 | 2006-01-19 | Bio-Rad Laboratories, Inc. | Multichemistry fractionation |
| ATE546520T1 (de) * | 2007-01-04 | 2012-03-15 | Crucell Holland Bv | Faktor-xi-reinigung |
| EP2167526B1 (en) | 2007-07-11 | 2011-03-30 | Novo Nordisk A/S | Purification of factor viii using a mixed-mode or multimodal resin |
| EP2027875A1 (en) * | 2007-08-23 | 2009-02-25 | Octapharma AG | A Process for Isolation and Purification of a Target Protein free of Prion Protein (PrPSC) |
| FR2920429B1 (fr) * | 2007-08-30 | 2012-10-05 | Lfb Biotechnologies | Procede de purification du facteur viii et du facteur von willebrand |
| WO2009090056A2 (en) | 2008-01-18 | 2009-07-23 | F. Hoffmann-La Roche Ag | Purification of not-glycosylated polypeptides |
| SI2300497T1 (sl) * | 2008-06-24 | 2013-02-28 | Octapharma Ag | Postopek za äťiĺˇäťenje koagulacijskega faktorja viii |
| CA2785594C (en) * | 2010-01-08 | 2018-04-17 | Profibrix Bv | Fibrinogen preparations enriched in fibrinogen with an extended alpha chain |
| ES2586698T3 (es) * | 2010-09-20 | 2016-10-18 | Octapharma Ag | Proceso para la producción de fibrinógeno |
| EP2649087A1 (en) * | 2010-12-08 | 2013-10-16 | Amgen Inc. | Ion exchange chromatography in the presence of an amino acid |
| WO2013135684A1 (en) | 2012-03-13 | 2013-09-19 | Octapharma Ag | Improved process for production of fibrinogen and fibrinogen produced thereby |
| US20140154233A1 (en) | 2012-12-05 | 2014-06-05 | Csl Limited | Method of purifying therapeutic proteins |
-
2013
- 2013-03-14 US US13/803,740 patent/US20140154233A1/en not_active Abandoned
- 2013-04-10 AU AU2013203357A patent/AU2013203357B2/en active Active
- 2013-12-05 SG SG11201504372UA patent/SG11201504372UA/en unknown
- 2013-12-05 RU RU2015126551A patent/RU2685956C2/ru active
- 2013-12-05 CN CN201811091750.9A patent/CN109125714B/zh active Active
- 2013-12-05 EP EP18207150.6A patent/EP3483173A1/en active Pending
- 2013-12-05 WO PCT/AU2013/001414 patent/WO2014085861A1/en not_active Ceased
- 2013-12-05 EP EP13861334.4A patent/EP2928905B1/en active Active
- 2013-12-05 KR KR1020217010484A patent/KR102403847B1/ko active Active
- 2013-12-05 CA CA3185085A patent/CA3185085A1/en active Pending
- 2013-12-05 SG SG10201704484QA patent/SG10201704484QA/en unknown
- 2013-12-05 PL PL13861334T patent/PL2928905T3/pl unknown
- 2013-12-05 JP JP2015545601A patent/JP6411360B2/ja active Active
- 2013-12-05 CN CN201380063945.1A patent/CN104981476B/zh active Active
- 2013-12-05 BR BR112015012854-8A patent/BR112015012854B1/pt active IP Right Grant
- 2013-12-05 KR KR1020157017824A patent/KR102240978B1/ko active Active
- 2013-12-05 AU AU2013354899A patent/AU2013354899B2/en active Active
- 2013-12-05 CA CA2893373A patent/CA2893373A1/en not_active Abandoned
-
2014
- 2014-11-06 US US14/535,085 patent/US9598461B2/en active Active
-
2017
- 2017-02-03 US US15/424,072 patent/US20170143805A1/en not_active Abandoned
-
2018
- 2018-09-25 JP JP2018178301A patent/JP6836562B2/ja active Active
- 2018-12-10 US US16/214,519 patent/US11426680B2/en active Active
-
2021
- 2021-02-04 JP JP2021016182A patent/JP7774384B2/ja active Active
- 2021-03-01 US US17/188,173 patent/US20210283530A1/en active Pending
Also Published As
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| Publication | Publication Date | Title |
|---|---|---|
| JP7774384B2 (ja) | 治療タンパク質の精製方法 | |
| AU2003244850B2 (en) | Processes for the preparation of fibrinogen | |
| US10806755B2 (en) | Plasma-supplemented formulation | |
| US10188965B2 (en) | Hydrophobic charge induction chromatographic depletion of a protein from a solution | |
| HK40007788A (en) | Separation of fibrinogen, fviii and/or vwf from plasma proteases by hcic | |
| ES2711455T3 (es) | Un método de purificación de proteínas terapéuticas | |
| HK1214833B (en) | A method of purifying therapeutic proteins | |
| RU2559576C1 (ru) | Способ получения вирусбезопасного полного протромбинового комплекса |
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