PT2554160E - Método para preparar uma composição de igg enriquecida a partir do plasma - Google Patents

Método para preparar uma composição de igg enriquecida a partir do plasma Download PDF

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Publication number
PT2554160E
PT2554160E PT121901383T PT12190138T PT2554160E PT 2554160 E PT2554160 E PT 2554160E PT 121901383 T PT121901383 T PT 121901383T PT 12190138 T PT12190138 T PT 12190138T PT 2554160 E PT2554160 E PT 2554160E
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PT
Portugal
Prior art keywords
plasma
preparing
composition
igg enriched
igg
Prior art date
Application number
PT121901383T
Other languages
English (en)
Portuguese (pt)
Inventor
Wolfgang Teschner
Sonja Svatos
Hans-Peter Schwarz
Azra Pljevljakovic
Leopold Bruckschwaiger
Julia Nürnberger
Harald Arno Butterweck
Thomas Gundinger
Bernhard Koelbl
Reinhard Grausenburger
Original Assignee
Baxter Int
Baxter Healthcare Sa
Priority date (The priority date 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 date listed.)
Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42727304&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PT2554160(E) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Baxter Int, Baxter Healthcare Sa filed Critical Baxter Int
Publication of PT2554160E publication Critical patent/PT2554160E/pt

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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
    • 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
    • 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
    • A61K38/55—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
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
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    • 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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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • 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
    • 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
    • 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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  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • 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)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (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)
  • Developmental Biology & Embryology (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Virology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oncology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Urology & Nephrology (AREA)
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PT121901383T 2010-05-26 2010-05-27 Método para preparar uma composição de igg enriquecida a partir do plasma PT2554160E (pt)

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 (1)

Publication Number Publication Date
PT2554160E true PT2554160E (pt) 2015-06-11

Family

ID=42727304

Family Applications (4)

Application Number Title Priority Date Filing Date
PT121901383T PT2554160E (pt) 2010-05-26 2010-05-27 Método para preparar uma composição de igg enriquecida a partir do plasma
PT107275398T PT2445482E (pt) 2010-05-26 2010-05-27 Método para preparar uma composição de igg enriquecida a partir do plasma
PT117292003T PT2575762E (pt) 2010-05-26 2011-05-26 Remoção de serina proteases por tratamento com dióxido de silício finamente dividido
PT221644362T PT4039249T (pt) 2010-05-26 2011-05-26 Remoção de proteases da serina por tratamento com dióxido de silício finamente dividido

Family Applications After (3)

Application Number Title Priority Date Filing Date
PT107275398T PT2445482E (pt) 2010-05-26 2010-05-27 Método para preparar uma composição de igg enriquecida a partir do plasma
PT117292003T PT2575762E (pt) 2010-05-26 2011-05-26 Remoção de serina proteases por tratamento com dióxido de silício finamente dividido
PT221644362T PT4039249T (pt) 2010-05-26 2011-05-26 Remoção de proteases da serina por tratamento com dióxido de silício finamente dividido

Country Status (26)

Country Link
US (6) US8993734B2 (enExample)
EP (6) EP2803349B1 (enExample)
JP (6) JP5876474B2 (enExample)
KR (3) KR101593265B1 (enExample)
CN (5) CN102970975B (enExample)
AR (4) AR076800A1 (enExample)
AU (8) AU2010202125B1 (enExample)
BR (2) BR112012029893B1 (enExample)
CA (2) CA2800155A1 (enExample)
CL (3) CL2012003291A1 (enExample)
CO (2) CO6660438A2 (enExample)
DK (4) DK2554160T3 (enExample)
EA (4) EA023446B1 (enExample)
ES (4) ES2536093T3 (enExample)
FI (1) FI4039249T3 (enExample)
HK (1) HK1213790A1 (enExample)
HR (4) HRP20141109T1 (enExample)
HU (1) HUE064400T2 (enExample)
IL (2) IL223150A0 (enExample)
MX (4) MX349815B (enExample)
MY (3) MY173299A (enExample)
PL (5) PL2554160T3 (enExample)
PT (4) PT2554160E (enExample)
SG (3) SG185724A1 (enExample)
TW (3) TWI531577B (enExample)
WO (1) WO2011149472A1 (enExample)

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TWI489994B (zh) 2008-03-17 2015-07-01 Baxter Healthcare Sa 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法
US8546548B2 (en) 2009-05-27 2013-10-01 Baxter International Inc. Method to produce a highly concentrated immunoglobulin preparation for subcutaneous use
AU2010202125B1 (en) 2010-05-26 2010-09-02 Takeda Pharmaceutical Company Limited A method to produce an immunoglobulin preparation with improved yield
PT2477603E (pt) * 2009-09-17 2016-06-16 Baxalta Inc Co-formulação estável de hialuronidase e imunoglobulina e métodos para a sua utilização
US10787701B2 (en) 2010-04-05 2020-09-29 Prognosys Biosciences, Inc. Spatially encoded biological assays
US8772462B2 (en) 2010-05-26 2014-07-08 Baxter International Inc. Removal of serine proteases by treatment with finely divided silicon dioxide
EP2596014B1 (en) * 2010-07-23 2018-11-28 Baxalta GmbH Manufacture of inter-alpha-inhibitor proteins (iaip) from plasma
EP2719704B1 (en) * 2011-04-08 2016-07-20 Universidad De Costa Rica Method for producing injectable formulations of blood-derived protein materials, and materials obtained using said method
WO2013090636A1 (en) 2011-12-13 2013-06-20 Baxter International Inc. Measurement of autoantibodies at low conductivity conditions with increased sensitivity
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
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
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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
GB201413227D0 (en) * 2014-07-25 2014-09-10 Bioproducts Lab Ltd Process
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WO2016161423A1 (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
US10583179B2 (en) * 2015-04-02 2020-03-10 Kieu Hoang Method of manufacturing and purifying prothrombin complex concentrate from Fraction III for intravenous injection and a method of curing and preventing Hemophilia A with inhibitors or Hemophilia B in patients infected with HIV-1 and HIV-2
US20170233458A1 (en) * 2015-09-29 2017-08-17 Kieu Hoang Method of manufacturing intravenous immunoglobulin from fraction iii
WO2017062536A2 (en) * 2015-10-06 2017-04-13 Kieu Hoang A method of manfacturing prothrombin complex concentrate from fraction iii and non-prothrombin complex concentrate from fraction iv
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WO2017176735A1 (en) 2016-04-05 2017-10-12 Haemonetics Corporation Methods and devices for the enrichment of immunoglobulin from blood
EP3275897A1 (en) * 2016-07-27 2018-01-31 Biotest AG Process for preparing immunoglobulin compositions
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DK2445482T3 (da) 2014-09-22
BR112012029897A2 (pt) 2016-08-16
HK1213790A1 (zh) 2016-07-15
AU2011258111A1 (en) 2012-12-13
PT4039249T (pt) 2026-04-27
AR121861A2 (es) 2022-07-20
EP2554160A1 (en) 2013-02-06
US20130101579A1 (en) 2013-04-25
AR114228A2 (es) 2020-08-05
AU2010224461A1 (en) 2010-10-21
US20210403504A1 (en) 2021-12-30
AU2016202973B2 (en) 2017-12-07
HK1215931A1 (zh) 2016-09-30
EP2803349B1 (en) 2023-09-27
PL4039249T3 (pl) 2026-05-11
KR101716534B1 (ko) 2017-03-14
CA2800155A1 (en) 2011-12-01
PL2554160T3 (pl) 2015-07-31
TWI504607B (zh) 2015-10-21
HK1203838A1 (en) 2015-11-06
ES2959234T3 (es) 2024-02-22
KR20130109016A (ko) 2013-10-07
SG185725A1 (en) 2012-12-28
JP5876474B2 (ja) 2016-03-02
CA2800272A1 (en) 2011-12-01

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