AR092400A1 - Formulaciones de anticuerpos y proteinas de alta concentracion - Google Patents
Formulaciones de anticuerpos y proteinas de alta concentracionInfo
- Publication number
- AR092400A1 AR092400A1 ARP130103099A ARP130103099A AR092400A1 AR 092400 A1 AR092400 A1 AR 092400A1 AR P130103099 A ARP130103099 A AR P130103099A AR P130103099 A ARP130103099 A AR P130103099A AR 092400 A1 AR092400 A1 AR 092400A1
- Authority
- AR
- Argentina
- Prior art keywords
- salt
- antibody
- protein
- antibody formulation
- formulation
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 17
- 108090000623 proteins and genes Proteins 0.000 title abstract 11
- 102000004169 proteins and genes Human genes 0.000 title abstract 11
- 238000009472 formulation Methods 0.000 abstract 16
- 235000018102 proteins Nutrition 0.000 abstract 10
- 229930006000 Sucrose Natural products 0.000 abstract 5
- 239000005720 sucrose Substances 0.000 abstract 5
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 abstract 4
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract 4
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 abstract 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 4
- 239000004475 Arginine Substances 0.000 abstract 3
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 abstract 3
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 3
- 229930182817 methionine Natural products 0.000 abstract 3
- 239000002736 nonionic surfactant Substances 0.000 abstract 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract 3
- 229920000053 polysorbate 80 Polymers 0.000 abstract 3
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 abstract 2
- 101100454808 Caenorhabditis elegans lgg-2 gene Proteins 0.000 abstract 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 2
- 239000004471 Glycine Substances 0.000 abstract 2
- 239000004472 Lysine Substances 0.000 abstract 2
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 abstract 2
- 229930195725 Mannitol Natural products 0.000 abstract 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 abstract 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 abstract 2
- 150000001413 amino acids Chemical group 0.000 abstract 2
- 239000008121 dextrose Substances 0.000 abstract 2
- 239000008103 glucose Substances 0.000 abstract 2
- 229910017053 inorganic salt Inorganic materials 0.000 abstract 2
- 239000000594 mannitol Substances 0.000 abstract 2
- 235000010355 mannitol Nutrition 0.000 abstract 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract 2
- 229940068968 polysorbate 80 Drugs 0.000 abstract 2
- 150000005846 sugar alcohols Chemical class 0.000 abstract 2
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 abstract 1
- 229920001213 Polysorbate 20 Polymers 0.000 abstract 1
- 235000004279 alanine Nutrition 0.000 abstract 1
- 201000010099 disease Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 abstract 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 abstract 1
- 229920000136 polysorbate Polymers 0.000 abstract 1
- 229950008882 polysorbate Drugs 0.000 abstract 1
- 229940068977 polysorbate 20 Drugs 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 125000000185 sucrose group Chemical group 0.000 abstract 1
Classifications
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- 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
- A61K9/0012—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
-
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
-
- 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
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/38—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against protease inhibitors of peptide structure
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
Se proporcionan formulaciones de alta concentración sin sal de anticuerpos y otras proteínas que son sustancialmente isosmóticas y de baja viscosidad. También se proporcionan procedimientos para el tratamiento de enfermedades usando las formulaciones divulgadas. Reivindicación 1: Una formulación de proteína o anticuerpo sin sal, que comprende: a) 10 mM a 30 mM de histidina; b) 50 ppm a 200 ppm de un tensioactivo no iónico; c) 88 mM a 292 mM de un azúcar o alcohol de azúcar seleccionado entre manitol, dextrosa, glucosa, trehalosa y sacarosa; d) 0 mM a 50 mM de arginina; e) 0 mM a 50 mM de lisina; f) 0 mM a 133 mM de glicina o alanina; g) 0 mM a 10 mM de metionina; y h) 20 mg/ml a 150 mg/ml de una proteína o un anticuerpo; en la que dicha formulación de proteína o anticuerpo tiene un pH que varía de pH 4,0 a pH 6,0 y en la que dicha formulación de proteína no contiene sustancialmente sal inorgánica. Reivindicación 4: La formulación de proteína o anticuerpo sin sal de cualquiera de la reivindicación 1, en la que dicho tensioactivo no iónico es un polisorbato seleccionado entre polisorbato 20 y polisorbato 80. Reivindicación 5: La formulación de proteína o anticuerpo sin sal de la reivindicación 1, en la que dicho azúcar es sacarosa. Reivindicación 7: La formulación de proteína o anticuerpo sin sal de la reivindicación 1, que comprende: a) 30 mM de histidina, b) 100 ppm de polisorbato 80, c) 292 mM de sacarosa, y d) 20 mg/ml de proteína o anticuerpo; en la que dicha formulación de proteína o anticuerpo tiene un pH que varía de pH 5,0 a pH 6,0. Reivindicación 17: Una formulación de anticuerpo anti-TFPI sin sal, que comprende: a) 10 mM a 30 mM de histidina, b) 50 ppm a 200 ppm de un tensioactivo no iónico, c) 88 mM a 292 mM de un azúcar o alcohol de azúcar seleccionado entre manitol, dextrosa, glucosa, trehalosa y sacarosa, d) 0 mM a 50 mM de arginina, e) 0 mM a 50 mM de lisina, f) 0 mM a 133 mM de glicina o alanita, g) 0 mM a 10 mM de metionina, y h) 20 mg/ml a 150 mg/ml de anticuerpo anti-TFPI; en la que dicha formulación de anticuerpo anti-TFPI tiene un pH de pH 4,0 a pH 6,0 y en la que dicha formulación de anticuerpo anti-TFPI no contiene sustancialmente sal inorgánica. Reivindicación 22: La formulación de anticuerpo anti-TFPI sin sal de la reivindicación 17, que comprende: a) 10 mM de histidina, b) 75 ppm de Tween 80, c) 234 mM de sacarosa, d) 30 mM de arginina, y e) 10 mM de metionina, y f) 100 mg/ml de anticuerpo anti-TFPI; en la que dicha formulación de anticuerpo anti-TFPI tiene un pH de 5,5. Reivindicación 23: La formulación de anticuerpo anti-TFPI sin sal de la reivindicación 17, en la que dicho anticuerpo anti-TFPI es un anticuerpo monoclonal lgG₂ humano. Reivindicación 24: La formulación de anticuerpo anti-TFPI sin sal de la reivindicación 17, en la que dicho anticuerpo monoclonal lgG₂ humano comprende una cadena ligera que comprende la secuencia de aminoácidos de SEC ID Nº 1 y una cadena pesada que comprende la secuencia de aminoácidos de SEC ID Nº 2.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US13/601,598 US8613919B1 (en) | 2012-08-31 | 2012-08-31 | High concentration antibody and protein formulations |
| US13/843,780 US9592297B2 (en) | 2012-08-31 | 2013-03-15 | Antibody and protein formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR092400A1 true AR092400A1 (es) | 2015-04-22 |
Family
ID=49162239
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP130103085A AR092388A1 (es) | 2012-08-31 | 2013-08-29 | Formulaciones de anticuerpo y proteina |
| ARP130103099A AR092400A1 (es) | 2012-08-31 | 2013-08-30 | Formulaciones de anticuerpos y proteinas de alta concentracion |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP130103085A AR092388A1 (es) | 2012-08-31 | 2013-08-29 | Formulaciones de anticuerpo y proteina |
Country Status (26)
| Country | Link |
|---|---|
| US (7) | US9592297B2 (es) |
| EP (3) | EP2890718A1 (es) |
| JP (3) | JP6462567B2 (es) |
| CN (2) | CN114392353A (es) |
| AR (2) | AR092388A1 (es) |
| AU (3) | AU2013308902B2 (es) |
| BR (1) | BR112015003838A2 (es) |
| CA (2) | CA2883095C (es) |
| CY (1) | CY1121989T1 (es) |
| DK (1) | DK3117837T3 (es) |
| ES (1) | ES2741575T3 (es) |
| HK (1) | HK1210794A1 (es) |
| HR (1) | HRP20191299T1 (es) |
| HU (1) | HUE045652T2 (es) |
| IL (6) | IL294567A (es) |
| LT (1) | LT3117837T (es) |
| MX (2) | MX369653B (es) |
| PL (1) | PL3117837T3 (es) |
| PT (1) | PT3117837T (es) |
| RS (1) | RS59221B1 (es) |
| RU (2) | RU2019100887A (es) |
| SG (2) | SG11201501116RA (es) |
| SI (1) | SI3117837T1 (es) |
| TW (4) | TW201414496A (es) |
| UY (1) | UY34995A (es) |
| WO (1) | WO2014036071A1 (es) |
Families Citing this family (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI2542257T1 (en) | 2010-03-01 | 2018-01-31 | Bayer Healthcare Llc | Optimized monoclonal antibodies against Tissue Factor Pathway Inhibitor (TFPI) |
| DK2694544T3 (en) * | 2011-04-01 | 2019-04-15 | Bayer Healthcare Llc | MONOCLONAL ANTIBODIES AGAINST TIBI FACTOR ACTIVITY INHIBITOR (TFPI) |
| AT512589B1 (de) * | 2012-03-12 | 2014-06-15 | Zizala Lichtsysteme Gmbh | Lichtleitelement für einen Laser-Fahrzeugscheinwerfer sowie Fahrzeugscheinwerfer |
| US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| IL312865B1 (en) | 2013-09-11 | 2025-02-01 | Eagle Biologics Inc | Liquid protein formulations containing viscosity-reducing agents |
| US10478498B2 (en) | 2014-06-20 | 2019-11-19 | Reform Biologics, Llc | Excipient compounds for biopolymer formulations |
| EP3201235A1 (en) | 2014-10-01 | 2017-08-09 | Medimmune Limited | Antibodies to ticagrelor and methods of use |
| MX2017004306A (es) | 2014-10-01 | 2017-12-20 | Eagle Biologics Inc | Formulaciones de polisacáridos y ácido nucleico que contienen agentes de reducción de viscosidad. |
| EP3337827A2 (en) | 2015-08-19 | 2018-06-27 | Pfizer Inc | Tissue factor pathway inhibitor antibodies and uses thereof |
| PT3337502T (pt) * | 2015-08-19 | 2020-09-23 | Astrazeneca Ab | Formulação anti-ifnar1 estável |
| TWI703158B (zh) | 2015-09-18 | 2020-09-01 | 美商希佛隆公司 | 特異性結合tl1a之抗體 |
| AU2016329034B2 (en) * | 2015-09-22 | 2019-05-23 | Pfizer Inc. | Method of preparing a therapeutic protein formulation and antibody formulation produced by such a method |
| JP2019511531A (ja) * | 2016-04-13 | 2019-04-25 | メディミューン，エルエルシー | 高濃度のタンパク質ベース治療薬を含有する医薬組成物における安定化化合物としてのアミノ酸の使用 |
| EP4338752A3 (en) | 2016-06-30 | 2024-04-03 | Celltrion, Inc. | Stable liquid pharmaceutical preparation |
| US10279048B2 (en) | 2016-07-13 | 2019-05-07 | Reform Biologics, Llc | Stabilizing excipients for therapeutic protein formulations |
| AU2017328632A1 (en) | 2016-09-16 | 2019-04-04 | Leukocare Ag | A novel method for stabilization of a biopharmaceutical drug product during processing |
| KR102595080B1 (ko) * | 2016-12-23 | 2023-10-30 | 세럼 인스티튜트 오브 인디아 프라이비트 리미티드 | 포유류 세포 배양에서 항체 생산성을 증강시키고 하류 제제화 프로세스 동안 응집을 최소화하기 위한 개선된 방법, 및 그로부터 수득된 안정한 항체 제제 |
| MX2019013072A (es) | 2017-05-02 | 2019-12-16 | Merck Sharp & Dohme | Formulaciones de anticuerpos anti-lag3 y coformulaciones de anticuerpos anti-lag3 y anticuerpos anti-pd-1. |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| EP3768706A1 (en) * | 2018-03-23 | 2021-01-27 | AbbVie Deutschland GmbH & Co. KG | Stable aqueous anti-tau antibody formulations |
| CN112739323A (zh) | 2018-05-10 | 2021-04-30 | 瑞泽恩制药公司 | 含有高浓度vegf受体融合蛋白的制剂 |
| PE20210462A1 (es) * | 2018-07-05 | 2021-03-08 | Bayer Ag | METODO PARA LA PRODUCCION DE GRANULOS LIOFILIZADOS QUE COMPRENDEN UN ANTICUERPO ANTI-FACTOR XIa (FXIa) DE LA COAGULACION |
| KR102337683B1 (ko) * | 2018-09-21 | 2021-12-13 | 주식회사 녹십자 | 고효율 항-tfpi 항체 조성물 |
| WO2020081408A1 (en) * | 2018-10-18 | 2020-04-23 | Merck Sharp & Dohme Corp. | Formulations of anti-rsv antibodies and methods of use thereof |
| CN111346225A (zh) * | 2018-12-21 | 2020-06-30 | 上海张江生物技术有限公司 | 含有蛋白质的药物制剂 |
| CR20210435A (es) * | 2019-02-18 | 2021-09-20 | Lilly Co Eli | Formulación de anticuerpos terapéuticos |
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