JP6515105B2 - イオン性液体を含有する注射用液状タンパク質製剤およびその使用 - Google Patents

イオン性液体を含有する注射用液状タンパク質製剤およびその使用 Download PDF

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JP6515105B2
JP6515105B2 JP2016542116A JP2016542116A JP6515105B2 JP 6515105 B2 JP6515105 B2 JP 6515105B2 JP 2016542116 A JP2016542116 A JP 2016542116A JP 2016542116 A JP2016542116 A JP 2016542116A JP 6515105 B2 JP6515105 B2 JP 6515105B2
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viscosity
liquid pharmaceutical
protein
formulation
pharmaceutical formulation
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JP2016530321A5 (ja
JP2016530321A (ja
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アリシャ ケイ． ウェイト，
アリシャ ケイ． ウェイト，
アリッサ エム． ラーソン，
アリッサ エム． ラーソン，
ランガー，　ロバート　エス．
ロバート エス． ランガー，
アレクサンダー エム． クリバノフ，
アレクサンダー エム． クリバノフ，
ケビン ラブ，
ケビン ラブ，
アラン クレーン，
アラン クレーン，
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イーグル バイオロジクス， インコーポレイテッド
イーグル バイオロジクス， インコーポレイテッド
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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G3/00—Ambulance aspects of vehicles; Vehicles with special provisions for transporting patients or disabled persons, or their personal conveyances, e.g. for facilitating access of, or for loading, wheelchairs
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/20—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
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    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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    • 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
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    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
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    • 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
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    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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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
    • 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
    • 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
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], 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
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P20/00—Technologies relating to chemical industry
    • Y02P20/50—Improvements relating to the production of bulk chemicals
    • Y02P20/54—Improvements relating to the production of bulk chemicals using solvents, e.g. supercritical solvents or ionic liquids

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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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Analytical Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Communicable Diseases (AREA)
  • Neurology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
JP2016542116A 2013-09-11 2014-09-11 イオン性液体を含有する注射用液状タンパク質製剤およびその使用 Active JP6515105B2 (ja)

Applications Claiming Priority (17)

Application Number Priority Date Filing Date Title
US201361876621P 2013-09-11 2013-09-11
US61/876,621 2013-09-11
US201461940227P 2014-02-14 2014-02-14
US61/940,227 2014-02-14
US201461943197P 2014-02-21 2014-02-21
US61/943,197 2014-02-21
US201461946436P 2014-02-28 2014-02-28
US61/946,436 2014-02-28
US201461988005P 2014-05-02 2014-05-02
US61/988,005 2014-05-02
US201462008050P 2014-06-05 2014-06-05
US62/008,050 2014-06-05
US201462026497P 2014-07-18 2014-07-18
US62/026,497 2014-07-18
US201462030521P 2014-07-29 2014-07-29
US62/030,521 2014-07-29
PCT/US2014/055245 WO2015038811A2 (en) 2013-09-11 2014-09-11 Liquid protein formulations containing ionic liquids

Related Child Applications (1)

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JP2019031843A Division JP6768858B2 (ja) 2013-09-11 2019-02-25 イオン性液体を含有する液状タンパク質製剤

Publications (3)

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JP2016530321A JP2016530321A (ja) 2016-09-29
JP2016530321A5 JP2016530321A5 (ja) 2017-10-05
JP6515105B2 true JP6515105B2 (ja) 2019-05-15

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JP2016542103A Active JP6469113B2 (ja) 2013-09-11 2014-09-11 水溶性有機色素を含有する液状タンパク質製剤
JP2016542118A Active JP6463581B2 (ja) 2013-09-11 2014-09-11 粘度低下剤を含む液状タンパク質製剤
JP2016542105A Active JP6412575B2 (ja) 2013-09-11 2014-09-11 有機ホスフェートを含有する液状タンパク質製剤
JP2016542116A Active JP6515105B2 (ja) 2013-09-11 2014-09-11 イオン性液体を含有する注射用液状タンパク質製剤およびその使用
JP2018183794A Active JP6564512B2 (ja) 2013-09-11 2018-09-28 有機ホスフェートを含有する液状タンパク質製剤
JP2018248768A Active JP6774484B2 (ja) 2013-09-11 2018-12-29 粘度低下剤を含む液状タンパク質製剤
JP2019031843A Active JP6768858B2 (ja) 2013-09-11 2019-02-25 イオン性液体を含有する液状タンパク質製剤
JP2019108536A Active JP6941137B2 (ja) 2013-09-11 2019-06-11 イオン性液体を含有する液状タンパク質製剤
JP2019137552A Active JP6840797B2 (ja) 2013-09-11 2019-07-26 有機ホスフェートを含有する液状タンパク質製剤
JP2020167521A Active JP7214697B2 (ja) 2013-09-11 2020-10-02 粘度低下剤を含む液状タンパク質製剤
JP2022200135A Active JP7583455B2 (ja) 2013-09-11 2022-12-15 粘度低下剤を含む液状タンパク質製剤
JP2024188410A Pending JP2025010224A (ja) 2013-09-11 2024-10-25 粘度低下剤を含む液状タンパク質製剤

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JP2016542103A Active JP6469113B2 (ja) 2013-09-11 2014-09-11 水溶性有機色素を含有する液状タンパク質製剤
JP2016542118A Active JP6463581B2 (ja) 2013-09-11 2014-09-11 粘度低下剤を含む液状タンパク質製剤
JP2016542105A Active JP6412575B2 (ja) 2013-09-11 2014-09-11 有機ホスフェートを含有する液状タンパク質製剤

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JP2018183794A Active JP6564512B2 (ja) 2013-09-11 2018-09-28 有機ホスフェートを含有する液状タンパク質製剤
JP2018248768A Active JP6774484B2 (ja) 2013-09-11 2018-12-29 粘度低下剤を含む液状タンパク質製剤
JP2019031843A Active JP6768858B2 (ja) 2013-09-11 2019-02-25 イオン性液体を含有する液状タンパク質製剤
JP2019108536A Active JP6941137B2 (ja) 2013-09-11 2019-06-11 イオン性液体を含有する液状タンパク質製剤
JP2019137552A Active JP6840797B2 (ja) 2013-09-11 2019-07-26 有機ホスフェートを含有する液状タンパク質製剤
JP2020167521A Active JP7214697B2 (ja) 2013-09-11 2020-10-02 粘度低下剤を含む液状タンパク質製剤
JP2022200135A Active JP7583455B2 (ja) 2013-09-11 2022-12-15 粘度低下剤を含む液状タンパク質製剤
JP2024188410A Pending JP2025010224A (ja) 2013-09-11 2024-10-25 粘度低下剤を含む液状タンパク質製剤

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US (13) US9925263B2 (enExample)
EP (8) EP3043774B1 (enExample)
JP (12) JP6469113B2 (enExample)
KR (5) KR102651018B1 (enExample)
CN (7) CN105722500B (enExample)
AU (10) AU2014318691B2 (enExample)
CA (4) CA2924069C (enExample)
ES (5) ES2980815T3 (enExample)
HK (1) HK1226309A1 (enExample)
IL (5) IL312865B2 (enExample)
MX (6) MX382917B (enExample)
RU (2) RU2710542C2 (enExample)
SG (6) SG10201806539XA (enExample)
SI (4) SI3043775T1 (enExample)
WO (4) WO2015038782A1 (enExample)
ZA (5) ZA201601968B (enExample)

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SMT201900549T1 (it) 2010-03-12 2019-11-13 Debiopharm Int Sa Molecole leganti il cd37 e loro immunoconiugati
EA201391342A1 (ru) 2011-04-01 2014-11-28 Иммьюноджен, Инк. Cd37-связывающие молекулы и их иммуноконъюгаты
US20140348719A1 (en) * 2013-03-14 2014-11-27 Bureau Veritas Pharmaceutical compound stabilizing filter compositions and methods of making and using same
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
JP6841656B2 (ja) * 2013-12-17 2021-03-10 ジェネンテック， インコーポレイテッド Ｐｄ−１軸結合アンタゴニスト及びタキサンを使用する癌の治療方法
EP4309653A1 (en) 2014-02-07 2024-01-24 Exithera Pharmaceuticals Inc. Therapeutic compounds and compositions
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
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