AU2010202125B1 - A method to produce an immunoglobulin preparation with improved yield - Google Patents
A method to produce an immunoglobulin preparation with improved yield Download PDFInfo
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- AU2010202125B1 AU2010202125B1 AU2010202125A AU2010202125A AU2010202125B1 AU 2010202125 B1 AU2010202125 B1 AU 2010202125B1 AU 2010202125 A AU2010202125 A AU 2010202125A AU 2010202125 A AU2010202125 A AU 2010202125A AU 2010202125 B1 AU2010202125 B1 AU 2010202125B1
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- igg
- composition
- alcohol
- precipitation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A61K35/16—Blood plasma; Blood serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
-
- 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
- A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
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- A—HUMAN NECESSITIES
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/55—Protease inhibitors
- A61K38/57—Protease inhibitors from animals; from humans
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
- A61K39/39525—Purification
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0026—Blood substitute; Oxygen transporting formulations; Plasma extender
-
- A—HUMAN NECESSITIES
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- 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
- B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
- B01D15/12—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the preparation of the feed
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- 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
- B01D15/362—Cation-exchange
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
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- 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
-
- 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
- B01D15/42—Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
- B01D15/424—Elution mode
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/02—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
- B01J20/10—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising silica or silicate
-
- 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
- C07K1/30—Extraction; Separation; Purification by precipitation
-
- 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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- 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
-
- 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
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (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)
- Analytical Chemistry (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Zoology (AREA)
- Cell Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biotechnology (AREA)
- Biomedical Technology (AREA)
- Developmental Biology & Embryology (AREA)
- Virology (AREA)
- Dermatology (AREA)
- Marine Sciences & Fisheries (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Diabetes (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Ophthalmology & Optometry (AREA)
Priority Applications (106)
| 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 |
| ES14176511T ES2959234T3 (es) | 2010-05-26 | 2010-05-27 | Procedimiento para preparar una composición de IgG enriquecida a partir de plasma |
| SG10201505161SA SG10201505161SA (en) | 2010-05-26 | 2010-05-27 | Method For Preparing An Enriched IGG Composition From Plasma |
| HK12110936.2A HK1170168B (en) | 2010-05-26 | 2010-05-27 | Method for preparing an enriched igg composition from plasma |
| CN201510158213.1A CN104958761B (zh) | 2010-05-26 | 2010-05-27 | 从血浆制备富含IgG的组合物的方法 |
| ARP100101844A AR076800A1 (es) | 2010-05-26 | 2010-05-27 | Metodo para producir una preparacion de inmunoglobulina con un alto rendimiento |
| KR1020127033758A KR101593265B1 (ko) | 2010-05-26 | 2010-05-27 | 혈장으로부터 IgG가 풍부한 조성물을 준비하는 방법 |
| PL10727539T PL2445482T3 (pl) | 2010-05-26 | 2010-05-27 | Sposób wytwarzania z osocza kompozycji wzbogaconej IgG |
| PCT/US2010/036470 WO2011149472A1 (en) | 2010-05-26 | 2010-05-27 | Method for preparing an enriched igg composition from plasma |
| CA2800155A CA2800155A1 (en) | 2010-05-26 | 2010-05-27 | Method for preparing an enriched igg composition from plasma |
| US12/789,365 US8993734B2 (en) | 2010-05-26 | 2010-05-27 | Method to produce an immunoglobulin preparation with improved yield |
| ES12190138.3T ES2536093T3 (es) | 2010-05-26 | 2010-05-27 | Procedimiento para preparar una composición de IgG enriquecida a partir de plasma |
| EA201500848A EA034602B1 (ru) | 2010-05-26 | 2010-05-27 | Способ получения обогащенной igg-композиции из криосупернатантной плазмы |
| DK10727539.8T DK2445482T3 (da) | 2010-05-26 | 2010-05-27 | Fremgangsmåde til fremstilling af beriget IgG sammensætning af plasma |
| EA201291355A EA023446B1 (ru) | 2010-05-26 | 2010-05-27 | СПОСОБ ПОЛУЧЕНИЯ ОБОГАЩЕННОЙ IgG-КОМПОЗИЦИИ ИЗ ПЛАЗМЫ |
| CN201080067929.6A CN102970975B (zh) | 2010-05-26 | 2010-05-27 | 从血浆制备富含IgG的组合物的方法 |
| MX2014006981A MX364252B (es) | 2010-05-26 | 2010-05-27 | Método para producir una preparación de inmunoglobulina con un rendimiento mejorado. |
| MX2012013682A MX349815B (es) | 2010-05-26 | 2010-05-27 | Metodo para producir una preparacion de inmunoglobulina con un rendimiento mejorado. |
| TW099117123A TWI531577B (zh) | 2010-05-26 | 2010-05-27 | 具有高產率之產製免疫球蛋白製備物的方法 |
| PT121901383T PT2554160E (pt) | 2010-05-26 | 2010-05-27 | Método para preparar uma composição de igg enriquecida a partir do plasma |
| EP10727539.8A EP2445482B1 (en) | 2010-05-26 | 2010-05-27 | Method for preparing an enriched igg composition from plasma |
| BR112012029893-3A BR112012029893B1 (pt) | 2010-05-26 | 2010-05-27 | Método para preparar uma composição de igg enriquecida a partir de plasma |
| DK12190138T DK2554160T3 (da) | 2010-05-26 | 2010-05-27 | Fremgangsmåde til fremstilling af en beriget IgG-sammensætning fra plasma |
| SG2012086245A SG185724A1 (en) | 2010-05-26 | 2010-05-27 | Method for preparing an enriched igg composition from plasma |
| PL12190138T PL2554160T3 (pl) | 2010-05-26 | 2010-05-27 | Sposób wytwarzania z osocza kompozycji wzbogaconej w IgG |
| ES10727539.8T ES2525492T3 (es) | 2010-05-26 | 2010-05-27 | Procedimiento para preparar una composiciónde IgG enriquecida a partir de plasma |
| PT107275398T PT2445482E (pt) | 2010-05-26 | 2010-05-27 | Método para preparar uma composição de igg enriquecida a partir do plasma |
| EP12190138.3A EP2554160B1 (en) | 2010-05-26 | 2010-05-27 | Method for preparing an enriched IgG composition from plasma |
| MYPI2015002952A MY173299A (en) | 2010-05-26 | 2010-05-27 | Method for preparing an enriched igg composition from plasma |
| JP2013512585A JP5876474B2 (ja) | 2010-05-26 | 2010-05-27 | 血漿由来の富化IgG組成物を調製する方法 |
| HRP20141109AT HRP20141109T1 (hr) | 2010-05-26 | 2010-05-27 | Postupak za pripravu obogaä†enog sastava igg iz plazme |
| KR1020167002347A KR101647617B1 (ko) | 2010-05-26 | 2010-05-27 | 혈장으로부터 IgG가 풍부한 조성물을 준비하는 방법 |
| MYPI2012005077A MY160551A (en) | 2010-05-26 | 2010-05-27 | Method for preparing an enriched igg composition from plasma |
| HUE14176511A HUE064400T2 (hu) | 2010-05-26 | 2010-05-27 | Eljárás dúsított IgG-készítmény elõállítására plazmából |
| EP14176511.5A EP2803349B1 (en) | 2010-05-26 | 2010-05-27 | Method for preparing an enriched IgG composition from plasma |
| PL14176511.5T PL2803349T3 (pl) | 2010-05-26 | 2010-05-27 | Sposób wytwarzania wzbogaconej kompozycji IgG z osocza |
| AU2010224461A AU2010224461B2 (en) | 2010-05-26 | 2010-09-29 | A method to produce an immunoglobulin preparation with improved yield |
| US13/085,056 US8796430B2 (en) | 2010-05-26 | 2011-04-12 | Method to produce an immunoglobulin preparation with improved yield |
| PCT/US2011/038247 WO2011150284A2 (en) | 2010-05-26 | 2011-05-26 | Removal of serine proteases by treatment with finely divided silicon dioxide |
| TW100118581A TWI504607B (zh) | 2010-05-26 | 2011-05-26 | 以微細分之二氧化矽處理移除絲胺酸蛋白酶 |
| PL11729200T PL2575762T3 (pl) | 2010-05-26 | 2011-05-26 | Usuwanie proteazy serynowej przez traktowanie subtelnie rozdrobnionym dwutlenkiem krzemu |
| EP20140166189 EP2796128A1 (en) | 2010-05-26 | 2011-05-26 | Enrichment of factor H out of plasma |
| ES11729200.3T ES2505465T3 (es) | 2010-05-26 | 2011-05-26 | Retirada de serina proteasas por tratamiento con dióxido de silicio finamente dividido |
| JP2013512262A JP5866345B2 (ja) | 2010-05-26 | 2011-05-26 | 微細二酸化シリコンを用いた処理によるセリンプロテアーゼ除去法 |
| DK22164436.2T DK4039249T3 (da) | 2010-05-26 | 2011-05-26 | Fjernelse af serinproteaser ved behandling med findelt siliciumdioxid |
| MYPI2012005078A MY161617A (en) | 2010-05-26 | 2011-05-26 | Removal of serine proteases by treatment with finely divided silicon dioxide |
| DK11729200.3T DK2575762T3 (da) | 2010-05-26 | 2011-05-26 | Fjernelse af serinproteaser ved behandling med findelt silicium-dioxid |
| CN201180036374.3A CN103068365B (zh) | 2010-05-26 | 2011-05-26 | 通过用微细分的二氧化硅处理去除丝氨酸蛋白酶 |
| AU2011258111A AU2011258111B2 (en) | 2010-05-26 | 2011-05-26 | Removal of serine proteases by treatment with finely divided silicon dioxide |
| HK13110932.5A HK1183449B (en) | 2010-05-26 | 2011-05-26 | Removal of serine proteases by treatment with finely divided silicon dioxide |
| PT117292003T PT2575762E (pt) | 2010-05-26 | 2011-05-26 | Remoção de serina proteases por tratamento com dióxido de silício finamente dividido |
| HRP20260340TT HRP20260340T1 (hr) | 2010-05-26 | 2011-05-26 | Uklanjanje serinskih proteaza tretiranjem sitno podijeljenim silicijevim dioksidom |
| US13/117,028 US8772462B2 (en) | 2010-05-26 | 2011-05-26 | Removal of serine proteases by treatment with finely divided silicon dioxide |
| MX2012013689A MX337028B (es) | 2010-05-26 | 2011-05-26 | Eliminacion de serina proteasas por tratamiento con dioxido de silicona finamente dividido. |
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| US9468675B2 (en) | 2010-05-26 | 2016-10-18 | Baxalta Incorporated | Removal of serine proteases by treatment with finely divided silicon dioxide |
| US9708391B2 (en) | 2010-05-26 | 2017-07-18 | Baxalta Incorporated | Removal of serine proteases by treatment with finely divided silicon dioxide |
| US10208106B2 (en) | 2010-05-26 | 2019-02-19 | Baxalta Incorporated | Removal of serine proteases by treatment with finely divided silicon dioxide |
| US10875906B2 (en) | 2010-05-26 | 2020-12-29 | Baxalta Incorporated | Removal of serine proteases by treatment with finely divided silicon dioxide |
| US11136350B2 (en) | 2010-05-26 | 2021-10-05 | Takeda Pharmaceutical Company Limited | Method to produce an immunoglobulin preparation with improved yield |
| US11891431B2 (en) | 2010-05-26 | 2024-02-06 | Takeda Pharm Limited ceutical Company Limited | Removal of serine proteases by treatment with finely divided silicon dioxide |
| US12545703B2 (en) | 2010-05-26 | 2026-02-10 | Takeda Pharmaceutical Company Limited | Method to produce an immunoglobulin preparation with improved yield |
| CN103476786A (zh) * | 2011-04-08 | 2013-12-25 | 哥斯达黎加大学 | 一种生产血液来源蛋白质注射制剂的方法,以及使用上述方法获得的蛋白质物料 |
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