EA034602B1 - Способ получения обогащенной igg-композиции из криосупернатантной плазмы - Google Patents

Способ получения обогащенной igg-композиции из криосупернатантной плазмы Download PDF

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Publication number
EA034602B1
EA034602B1 EA201500848A EA201500848A EA034602B1 EA 034602 B1 EA034602 B1 EA 034602B1 EA 201500848 A EA201500848 A EA 201500848A EA 201500848 A EA201500848 A EA 201500848A EA 034602 B1 EA034602 B1 EA 034602B1
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EA
Eurasian Patent Office
Prior art keywords
igg
iii
fraction
suspension
solution
Prior art date
Application number
EA201500848A
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English (en)
Russian (ru)
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EA201500848A1 (ru
Inventor
Леопольд Брукшвайгер
Соня Сфатос
Юлиа Нюрнбергер
Вольфганг Тешнер
Харальд Арно Буттервек
Ханс-Петер Шварц
Томас Гундингер
Бернхард Кельбль
Райнхард Граузенбургер
Азра Плевляковиц
Original Assignee
Баксалта Инкорпорейтед
Баксалта Гмбх
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Application filed by Баксалта Инкорпорейтед, Баксалта Гмбх filed Critical Баксалта Инкорпорейтед
Publication of EA201500848A1 publication Critical patent/EA201500848A1/ru
Publication of EA034602B1 publication Critical patent/EA034602B1/ru

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14Blood; Artificial blood
    • A61K35/16Blood plasma; Blood serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/55Protease inhibitors
    • A61K38/57Protease inhibitors from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39516Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
    • A61K39/39525Purification
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0026Blood substitute; Oxygen transporting formulations; Plasma extender
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • AHUMAN NECESSITIES
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    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/12Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the preparation of the feed
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • B01D15/362Cation-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • B01D15/363Anion-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/42Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424Elution mode
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/02Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
    • B01J20/10Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising silica or silicate
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/30Extraction; Separation; Purification by precipitation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/34Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis

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  • Animal Behavior & Ethology (AREA)
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  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
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  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Developmental Biology & Embryology (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Virology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oncology (AREA)
  • Urology & Nephrology (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
EA201500848A 2010-05-26 2010-05-27 Способ получения обогащенной igg-композиции из криосупернатантной плазмы EA034602B1 (ru)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AU2010202125A AU2010202125B1 (en) 2010-05-26 2010-05-26 A method to produce an immunoglobulin preparation with improved yield

Publications (2)

Publication Number Publication Date
EA201500848A1 EA201500848A1 (ru) 2016-06-30
EA034602B1 true EA034602B1 (ru) 2020-02-25

Family

ID=42727304

Family Applications (4)

Application Number Title Priority Date Filing Date
EA201500848A EA034602B1 (ru) 2010-05-26 2010-05-27 Способ получения обогащенной igg-композиции из криосупернатантной плазмы
EA201291355A EA023446B1 (ru) 2010-05-26 2010-05-27 СПОСОБ ПОЛУЧЕНИЯ ОБОГАЩЕННОЙ IgG-КОМПОЗИЦИИ ИЗ ПЛАЗМЫ
EA201291367A EA025826B1 (ru) 2010-05-26 2011-05-26 Удаление сериновых протеаз путем обработки тонкоизмельченным диоксидом кремния
EA201691558A EA034530B1 (ru) 2010-05-26 2011-05-26 Удаление сериновых протеаз путем обработки тонкоизмельченным диоксидом кремния

Family Applications After (3)

Application Number Title Priority Date Filing Date
EA201291355A EA023446B1 (ru) 2010-05-26 2010-05-27 СПОСОБ ПОЛУЧЕНИЯ ОБОГАЩЕННОЙ IgG-КОМПОЗИЦИИ ИЗ ПЛАЗМЫ
EA201291367A EA025826B1 (ru) 2010-05-26 2011-05-26 Удаление сериновых протеаз путем обработки тонкоизмельченным диоксидом кремния
EA201691558A EA034530B1 (ru) 2010-05-26 2011-05-26 Удаление сериновых протеаз путем обработки тонкоизмельченным диоксидом кремния

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Country Link
US (6) US8993734B2 (enExample)
EP (6) EP2803349B1 (enExample)
JP (6) JP5876474B2 (enExample)
KR (3) KR101647617B1 (enExample)
CN (5) CN102970975B (enExample)
AR (4) AR076800A1 (enExample)
AU (8) AU2010202125B1 (enExample)
BR (2) BR112012029893B1 (enExample)
CA (2) CA2800155A1 (enExample)
CL (3) CL2012003290A1 (enExample)
CO (2) CO6660438A2 (enExample)
DK (3) DK2554160T3 (enExample)
EA (4) EA034602B1 (enExample)
ES (4) ES2959234T3 (enExample)
HK (1) HK1213790A1 (enExample)
HR (3) HRP20141109T1 (enExample)
HU (1) HUE064400T2 (enExample)
IL (2) IL223149A (enExample)
MX (4) MX349815B (enExample)
MY (3) MY173299A (enExample)
PL (4) PL2445482T3 (enExample)
PT (3) PT2554160E (enExample)
SG (3) SG10201505161SA (enExample)
TW (3) TWI531577B (enExample)
WO (1) WO2011149472A1 (enExample)

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TWI532498B (zh) 2008-03-17 2016-05-11 巴克斯特保健公司 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法
EP2477603B1 (en) * 2009-09-17 2016-03-30 Baxalta Incorporated Stable co-formulation of hyaluronidase and immunoglobulin, and methods of use thereof
US10787701B2 (en) 2010-04-05 2020-09-29 Prognosys Biosciences, Inc. Spatially encoded biological assays
AU2010202125B1 (en) 2010-05-26 2010-09-02 Takeda Pharmaceutical Company Limited A method to produce an immunoglobulin preparation with improved yield
WO2011150284A2 (en) 2010-05-26 2011-12-01 Baxter International Inc. Removal of serine proteases by treatment with finely divided silicon dioxide
KR20130093607A (ko) * 2010-07-23 2013-08-22 백스터 인터내셔널 인코포레이티드 혈장으로부터 인터-알파-억제제 단백질 (iaip)의 제조
ES2596407T3 (es) * 2011-04-08 2017-01-09 Universidad De Costa Rica Método para la producción de formulaciones inyectables de productos proteicos hemoderivados y productos obtenidos utilizando dicho método
PT2791675T (pt) 2011-12-13 2018-07-27 Baxalta Inc Medição de autoanticorpos em condições de baixa condutividade
TWI629283B (zh) * 2012-02-23 2018-07-11 巴克斯歐塔公司 來自血漿中的免疫球蛋白之i-iv-1部分沉澱
RU2487725C1 (ru) * 2012-03-15 2013-07-20 Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации (ФГУП "НПО "Микроген" Минздрава России) Способ получения концентрированного иммуноглобулинового препарата для подкожного введения
AU2013203043B2 (en) 2013-03-15 2016-10-06 Takeda Pharmaceutical Company Limited Methods to produce a human plasma-derived igg preparation enriched in brain disease-related natural iggs
CN103197053B (zh) * 2013-03-15 2015-02-18 上海市血液中心 一种抗IgA抗体检测试剂盒
CN104072601A (zh) * 2014-07-03 2014-10-01 成都蓉生药业有限责任公司 血液制品中fii沉淀的制备方法
CN104086642A (zh) * 2014-07-03 2014-10-08 成都蓉生药业有限责任公司 血液制品中fi+iii上清的制备方法
CN104086646B (zh) * 2014-07-03 2018-10-09 成都蓉生药业有限责任公司 血液制品中fv沉淀的制备方法
GB201413227D0 (en) * 2014-07-25 2014-09-10 Bioproducts Lab Ltd Process
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CN204424090U (zh) 2014-11-28 2015-06-24 比亚迪股份有限公司 薄膜电容器
US20160289301A1 (en) * 2015-04-02 2016-10-06 Kieu Hoang Process of cloning and further purification to make a recombinant intravenous immunoglobulin
CN107921079A (zh) * 2015-04-02 2018-04-17 K·黄 由组分iii制造静脉注射免疫球蛋白的方法
CN107921080A (zh) * 2015-04-02 2018-04-17 K·黄 由组分iii制造并纯化出用于静脉注射的凝血酶原复合物浓缩剂的方法以及治疗和预防具有抑制剂的a型血友病或感染了hiv‑1和hiv‑2的b型血友病患者的方法
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