CN111971302A - 制备稳定的蛋白质组合物的方法 - Google Patents
制备稳定的蛋白质组合物的方法 Download PDFInfo
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- CN111971302A CN111971302A CN201980025383.9A CN201980025383A CN111971302A CN 111971302 A CN111971302 A CN 111971302A CN 201980025383 A CN201980025383 A CN 201980025383A CN 111971302 A CN111971302 A CN 111971302A
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- acid
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- 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
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- 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
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
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- 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
- A61K39/39591—Stabilisation, fragmentation
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- 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
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- C07—ORGANIC CHEMISTRY
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- 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
- C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode chromatography
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- C—CHEMISTRY; METALLURGY
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- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/18—Ion-exchange chromatography
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
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- 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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- C—CHEMISTRY; METALLURGY
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- 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
- C07K14/475—Growth factors; Growth regulators
- C07K14/505—Erythropoietin [EPO]
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- C—CHEMISTRY; METALLURGY
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- 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
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/53—Colony-stimulating factor [CSF]
- C07K14/535—Granulocyte CSF; Granulocyte-macrophage CSF
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- 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
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/70578—NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
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- C—CHEMISTRY; METALLURGY
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- 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
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
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- 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
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
- C07K14/7151—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
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- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
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- C—CHEMISTRY; METALLURGY
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- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2809—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
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- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2869—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2875—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2878—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
- C07K16/3069—Reproductive system, e.g. ovaria, uterus, testes, prostate
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/32—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- General Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Engineering & Computer Science (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Analytical Chemistry (AREA)
- Cell Biology (AREA)
- Toxicology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Water Supply & Treatment (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Biomedical Technology (AREA)
- Endocrinology (AREA)
- Neurology (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Reproductive Health (AREA)
- Oncology (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862656687P | 2018-04-12 | 2018-04-12 | |
| US62/656687 | 2018-04-12 | ||
| PCT/US2019/024683 WO2019199476A1 (en) | 2018-04-12 | 2019-03-28 | Methods for making stable protein compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN111971302A true CN111971302A (zh) | 2020-11-20 |
Family
ID=66251859
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201980025383.9A Pending CN111971302A (zh) | 2018-04-12 | 2019-03-28 | 制备稳定的蛋白质组合物的方法 |
Country Status (15)
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022123603A1 (en) * | 2020-12-09 | 2022-06-16 | Dr. Reddy's Laboratories Limited | Stable aqueous buffer free formulation of an integrin antibody |
| CN116940662A (zh) * | 2021-03-10 | 2023-10-24 | 博士伦爱尔兰有限公司 | 不含防腐剂的隐形眼镜处理溶液 |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2014018747A2 (en) | 2012-07-26 | 2014-01-30 | Momenta Pharmaceuticals, Inc. | Glycoproteins with anti-inflammatory properties |
| ES2708759T3 (es) | 2013-05-13 | 2019-04-11 | Momenta Pharmaceuticals Inc | Procedimientos para el tratamiento de la neurodegeneración |
| EP3058084A4 (en) | 2013-10-16 | 2017-07-05 | Momenta Pharmaceuticals, Inc. | Sialylated glycoproteins |
| RS67656B1 (sr) | 2018-05-10 | 2026-02-27 | Regeneron Pharma | Formulacije koje sadrže visoke koncentracije fuzionog proteina vegf receptora |
| WO2021097344A1 (en) * | 2019-11-13 | 2021-05-20 | Amgen Inc. | Method for reduced aggregate formation in downstream processing of bispecific antigen-binding molecules |
| CA3194520A1 (en) * | 2020-06-11 | 2021-12-16 | 2Seventy Bio, Inc. | Methods for manufacturing viral vectors |
| US12286451B2 (en) | 2020-11-23 | 2025-04-29 | Medtech Products Inc. | Borate ester complexes of α-hydroxy carboxylic acids and their conjugate base buffers |
| WO2024165043A1 (en) * | 2023-02-08 | 2024-08-15 | Beigene Switzerland Gmbh | Preparation methods for a highly concentrated pd1 antibody solution by applying single-pass tangential flow filtration (sptff) |
| CN117088974B (zh) * | 2023-08-14 | 2024-02-13 | 武汉健昊生物科技有限公司 | 一种抗体保存液 |
| WO2026159667A1 (en) * | 2025-01-24 | 2026-07-30 | Hovione Farmaciência Sa | Synthetic sugars as enablers for viscosity reduction of highly concentrated biological molecules |
| CN121587349B (zh) * | 2026-01-28 | 2026-06-09 | 内蒙古蒙牛乳业(集团)股份有限公司 | 高浓度无菌乳铁蛋白液及其制备方法 |
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| WO2006073417A2 (en) * | 2004-05-10 | 2006-07-13 | Curagen Corporation | Prophylactic and therapeutic uses of fgf-20 in radiation protection |
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| US20130195888A1 (en) * | 2007-11-30 | 2013-08-01 | Abbvie | Ultrafiltration and diafiltration formulation methods for protein processing |
| US20140154270A1 (en) * | 2012-05-21 | 2014-06-05 | Chen Wang | Purification of non-human antibodies using kosmotropic salt enhanced protein a affinity chromatography |
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| AU2005304973A1 (en) | 2004-11-05 | 2006-05-18 | Palingen, Inc. | Antibody induced cell membrane wounding |
| DK1915398T3 (en) | 2005-07-18 | 2016-07-04 | Amgen Inc | Humane anti-B7RP1 neutraliserende antistoffer |
| US20070190057A1 (en) | 2006-01-23 | 2007-08-16 | Jian Wu | Methods for modulating mannose content of recombinant proteins |
| WO2008119567A2 (en) | 2007-04-03 | 2008-10-09 | Micromet Ag | Cross-species-specific cd3-epsilon binding domain |
| TWI569810B (zh) * | 2007-06-26 | 2017-02-11 | 巴克斯歐塔公司 | 可水解之聚合茀基甲氧基羰基-連接劑 |
| JP5718640B2 (ja) | 2007-08-21 | 2015-05-13 | アムジエン・インコーポレーテツド | ヒトc−fms抗原結合性タンパク質 |
| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| JO3382B1 (ar) | 2008-12-23 | 2019-03-13 | Amgen Inc | أجسام مضادة ترتبط مع مستقبل cgrp بشري |
| JP5789521B2 (ja) * | 2009-03-03 | 2015-10-07 | グリフオルス・セラピユーテイクス・インコーポレーテツドGrifols Therapeutics,Inc. | プラスミノーゲンを製造するための組成物、方法およびキット;ならびにそれから製造されるプラスミン |
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2019
- 2019-03-28 EP EP19719397.2A patent/EP3774894A1/en active Pending
- 2019-03-28 EA EA202092464A patent/EA202092464A1/ru unknown
- 2019-03-28 CA CA3096374A patent/CA3096374A1/en active Pending
- 2019-03-28 WO PCT/US2019/024683 patent/WO2019199476A1/en not_active Ceased
- 2019-03-28 MX MX2020010724A patent/MX2020010724A/es unknown
- 2019-03-28 CN CN201980025383.9A patent/CN111971302A/zh active Pending
- 2019-03-28 SG SG11202010100QA patent/SG11202010100QA/en unknown
- 2019-03-28 MA MA052204A patent/MA52204A/fr unknown
- 2019-03-28 BR BR112020020854-0A patent/BR112020020854A2/pt unknown
- 2019-03-28 KR KR1020207032156A patent/KR102791798B1/ko active Active
- 2019-03-28 US US17/046,662 patent/US12679865B2/en active Active
- 2019-03-28 IL IL277797A patent/IL277797B1/en unknown
- 2019-03-28 JP JP2020555099A patent/JP7465215B2/ja active Active
- 2019-03-28 AU AU2019250882A patent/AU2019250882B2/en active Active
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2020
- 2020-10-08 CL CL2020002597A patent/CL2020002597A1/es unknown
- 2020-10-09 MX MX2025009986A patent/MX2025009986A/es unknown
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2024
- 2024-03-29 JP JP2024056116A patent/JP2024075786A/ja active Pending
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2026
- 2026-01-14 AU AU2026200233A patent/AU2026200233A1/en active Pending
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| AU2019250882A1 (en) | 2020-11-05 |
| MX2025009986A (es) | 2025-09-02 |
| EA202092464A1 (ru) | 2021-01-27 |
| CL2020002597A1 (es) | 2021-01-29 |
| JP2021521119A (ja) | 2021-08-26 |
| KR102791798B1 (ko) | 2025-04-07 |
| JP2024075786A (ja) | 2024-06-04 |
| MX2020010724A (es) | 2020-11-06 |
| JP7465215B2 (ja) | 2024-04-10 |
| WO2019199476A9 (en) | 2019-11-21 |
| WO2019199476A1 (en) | 2019-10-17 |
| KR20210005053A (ko) | 2021-01-13 |
| AU2026200233A1 (en) | 2026-01-29 |
| US12679865B2 (en) | 2026-07-14 |
| SG11202010100QA (en) | 2020-11-27 |
| AU2019250882B2 (en) | 2025-10-16 |
| EP3774894A1 (en) | 2021-02-17 |
| IL277797A (en) | 2020-11-30 |
| US20210163531A1 (en) | 2021-06-03 |
| MA52204A (fr) | 2021-02-17 |
| BR112020020854A2 (pt) | 2021-01-19 |
| CA3096374A1 (en) | 2019-10-17 |
| IL277797B1 (en) | 2024-11-01 |
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