JP6674910B2 - タンパク質配合物のための粘度低減賦形剤化合物 - Google Patents

タンパク質配合物のための粘度低減賦形剤化合物 Download PDF

Info

Publication number
JP6674910B2
JP6674910B2 JP2016574175A JP2016574175A JP6674910B2 JP 6674910 B2 JP6674910 B2 JP 6674910B2 JP 2016574175 A JP2016574175 A JP 2016574175A JP 2016574175 A JP2016574175 A JP 2016574175A JP 6674910 B2 JP6674910 B2 JP 6674910B2
Authority
JP
Japan
Prior art keywords
formulation
protein
viscosity
therapeutic
excipient
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
JP2016574175A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017519018A (ja
JP2017519018A5 (https=
Inventor
ソーン，デイビッド，エス．
ヴュートリッヒ，フィリップ
ポーティルラ，ロサ，カサド
マホニー，ロバート，ピー．
ムーディー，マーク
Original Assignee
リフォーム バイオロジックス，エルエルシー
リフォーム バイオロジックス，エルエルシー
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
Application filed by リフォーム バイオロジックス，エルエルシー, リフォーム バイオロジックス，エルエルシー filed Critical リフォーム バイオロジックス，エルエルシー
Publication of JP2017519018A publication Critical patent/JP2017519018A/ja
Publication of JP2017519018A5 publication Critical patent/JP2017519018A5/ja
Priority to JP2020039681A priority Critical patent/JP6983266B2/ja
Application granted granted Critical
Publication of JP6674910B2 publication Critical patent/JP6674910B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • A61K38/38—Albumins
    • A61K38/385—Serum albumin
    • 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
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • 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
    • 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
    • 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
    • A61K47/24—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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2462—Lysozyme (3.2.1.17)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01017—Lysozyme (3.2.1.17)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2016574175A 2014-06-20 2015-06-22 タンパク質配合物のための粘度低減賦形剤化合物 Expired - Fee Related JP6674910B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2020039681A JP6983266B2 (ja) 2014-06-20 2020-03-09 タンパク質配合物のための粘度低減賦形剤化合物

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201462014784P 2014-06-20 2014-06-20
US62/014,784 2014-06-20
US201462083623P 2014-11-24 2014-11-24
US62/083,623 2014-11-24
US201562136763P 2015-03-23 2015-03-23
US62/136,763 2015-03-23
PCT/US2015/036899 WO2015196187A1 (en) 2014-06-20 2015-06-22 Viscosity-reducing excipient compounds for protein formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2020039681A Division JP6983266B2 (ja) 2014-06-20 2020-03-09 タンパク質配合物のための粘度低減賦形剤化合物

Publications (3)

Publication Number Publication Date
JP2017519018A JP2017519018A (ja) 2017-07-13
JP2017519018A5 JP2017519018A5 (https=) 2018-08-02
JP6674910B2 true JP6674910B2 (ja) 2020-04-01

Family

ID=54936144

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2016574175A Expired - Fee Related JP6674910B2 (ja) 2014-06-20 2015-06-22 タンパク質配合物のための粘度低減賦形剤化合物
JP2020039681A Expired - Fee Related JP6983266B2 (ja) 2014-06-20 2020-03-09 タンパク質配合物のための粘度低減賦形剤化合物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2020039681A Expired - Fee Related JP6983266B2 (ja) 2014-06-20 2020-03-09 タンパク質配合物のための粘度低減賦形剤化合物

Country Status (9)

Country Link
US (6) US20160074515A1 (https=)
EP (2) EP3160484B1 (https=)
JP (2) JP6674910B2 (https=)
KR (2) KR20220153668A (https=)
CN (1) CN106535918B (https=)
BR (1) BR112016029906A8 (https=)
CA (1) CA2951716C (https=)
ES (1) ES2965722T3 (https=)
WO (2) WO2015196091A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020105215A (ja) * 2014-06-20 2020-07-09 リフォーム バイオロジックス，エルエルシー タンパク質配合物のための粘度低減賦形剤化合物

Families Citing this family (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
WO2020112855A1 (en) * 2018-11-29 2020-06-04 Reform Biologics, Llc Excipient compounds for protein processing
WO2021108427A1 (en) * 2019-11-26 2021-06-03 Reform Biologics, Llc Excipient compounds for biopolymer formulations
EP3200804A4 (en) 2014-10-01 2018-04-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
EP4324482A2 (en) * 2015-10-23 2024-02-21 Comera Life Sciences, Inc. Excipient compounds for biopolymer formulations
WO2018013673A1 (en) * 2016-07-13 2018-01-18 Reform Biologics, Llc Stabilizing excipients for therapeutic protein formulations
DK3500856T3 (da) 2016-08-18 2020-12-14 Regeneron Pharma Assay til bestemmelse af et proteins potentiale for at selvassociere ved hjælp af koncentrationsafhængig selvinteraktionsnanopartikelspektroskopi
EP3522918A1 (en) * 2016-10-06 2019-08-14 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
US11654112B2 (en) 2016-11-22 2023-05-23 Elektrofi, Inc. Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
JP2020507593A (ja) * 2017-02-16 2020-03-12 リフォーム バイオロジクス、エルエルシー タンパク質処理用賦形剤化合物
MA48461A (fr) 2017-04-28 2020-03-04 Amgen Inc Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation
MA48464A (fr) * 2017-04-28 2020-03-04 Amgen Inc Dipeptides n-acétylés et non acétylés contenant de l'arginine destinés à réduire la viscosité de compositions visqueuses de polypeptides thérapeutiques
AU2018263868A1 (en) 2017-05-02 2019-12-12 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CA3063324A1 (en) 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
AU2018306303A1 (en) 2017-07-25 2020-02-20 Elektrofi, Inc. Formation of particles including agents
JP2020530004A (ja) * 2017-08-03 2020-10-15 ジャズ ファーマシューティカルズ アイルランド リミテッド 核酸を高濃度で含む製剤
CA3074565A1 (en) 2017-09-05 2019-03-14 Merck Sharp & Dohme Corp. Compounds for reducing the viscosity of biological formulations
WO2019106206A1 (en) 2017-12-01 2019-06-06 Fyb 202 Project Gmbh Stable, low viscosity, high concentration liquid formulations of an anti-il-12/23p40 antibody
EP3761962A4 (en) * 2018-03-07 2021-12-15 ReForm Biologics, Inc. EXCIPIENT COMPOUNDS FOR PROTEIN-BASED FORMULATIONS
AU2019254483B2 (en) * 2018-04-16 2025-02-27 Merck Patent Gmbh Viscosity reduction of highly concentrated protein formulations
WO2019226969A1 (en) 2018-05-24 2019-11-28 Elektrofi, Inc. Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
EP3852724A4 (en) 2018-09-20 2022-07-06 Levo Therapeutics, Inc. CARBETOCIN DRUG PRODUCT AND PROCESS FOR ITS MANUFACTURE
TW202031283A (zh) 2018-09-20 2020-09-01 馬克 Ｃ 曼寧 穩定卡貝縮宮素鼻內製劑
KR102885113B1 (ko) 2018-10-18 2025-11-13 머크 샤프 앤드 돔 엘엘씨 항-rsv 항체의 제제 및 그의 사용 방법
CN120842406A (zh) 2018-10-31 2025-10-28 默沙东有限责任公司 抗人pd-1抗体晶体及其使用方法
CN113316458B (zh) 2018-11-07 2024-08-02 默沙东有限责任公司 抗lag3抗体和抗pd-1抗体的共制剂
EP3917500A2 (en) 2019-01-31 2021-12-08 Elektrofi, Inc. Particle formation and morphology
WO2021050953A1 (en) 2019-09-13 2021-03-18 Elektrofi, Inc. Compositions and methods for the delivery of therapeutic biologics for treatment of disease
JP2023522627A (ja) 2020-04-17 2023-05-31 エレクトロフィ，インコーポレイテッド 連続的な液滴形成及び脱水によって粒子を形成する方法
MX2023000557A (es) 2020-07-13 2023-02-13 Merck Patent Gmbh Excipientes reductores de la viscosidad y combinaciones de los mismos para formulaciones proteicas altamente concentradas.
EP4319795A4 (en) * 2021-04-09 2025-03-05 Avantor Performance Materials, LLC Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations
EP4456935A1 (en) 2021-12-30 2024-11-06 Baxter International Inc. Fibrinogen and thrombin solutions for a fibrin sealant and fibrin sealant kit
WO2023217813A2 (en) * 2022-05-12 2023-11-16 Merck Patent Gmbh Excipients for purification and virus filtration of biological fluids
KR20230167968A (ko) * 2022-06-03 2023-12-12 주식회사 녹십자홀딩스 점도 감소 부형제 조성물 및 이를 포함하는 저점도 고농축 단백질 제형
CN120936385A (zh) 2023-03-13 2025-11-11 海德堡医药研究有限责任公司 用于在癌症治疗中使用的皮下施用的抗体-药物缀合物
WO2025131987A1 (en) 2023-12-18 2025-06-26 Merck Patent Gmbh Viscosity reducing excipients and combinations thereof for liquid compositions comprising a protein

Family Cites Families (99)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2230965A (en) 1940-06-14 1941-02-04 American Cyanamid Co Process of preparing guanyl taurine
DE3128117A1 (de) 1980-07-29 1982-03-11 Yamanouchi Pharmaceutical Co., Ltd., Tokyo Neue phenyl-aethylaminderivate, verfahren zu ihrer herstellung
US4548827A (en) * 1982-03-30 1985-10-22 General Foods Corporation Separate recovery of caffeine and coffee solids adsorbed on activated carbon
CA1206370A (en) * 1982-08-17 1986-06-24 Ajinomoto Co., Inc. Stabilized aspartame compositions
US5164214A (en) * 1987-12-10 1992-11-17 Rudolf-Wild Gmbh & Co. Kg Sweetening agent
WO1989009402A1 (fr) 1988-03-30 1989-10-05 Toray Industries, Inc. PREPARATION LYOPHILISEE CONTENANT UN ANTICORPS DE L'INTERFERON beta ANTIHUMAIN MARQUE PAR UNE ENZYME ET KIT D'ANALYSE ENZYMATIQUE CONTENANT CETTE PREPARATION
US5849700A (en) 1991-12-20 1998-12-15 Novo Nordisk A/S Pharmaceutical formulation
DE4344824C1 (de) 1993-12-28 1995-08-31 Immuno Ag Hochkonzentriertes Immunglobulin-Präparat und Verfahren zu seiner Herstellung
GB9418092D0 (en) 1994-09-08 1994-10-26 Red Cross Found Cent Lab Blood Organic compounds
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US5900416A (en) 1996-02-01 1999-05-04 Anthea Enterprises Incorporated Aqueous caffeine dosage forms
KR100236393B1 (ko) 1996-02-02 1999-12-15 나까니시 히로유끼 사람성장호르몬을 함유하는 의약제제
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
DE60031999T2 (de) 1999-10-04 2007-06-06 Novartis Vaccines and Diagnostics, Inc., Emeryville Stabilisierte flüssige polypeptid-haltige pharmazeutische zusammensetzungen
US20040081702A1 (en) * 2000-04-14 2004-04-29 Kim Christopher M. Bee venom treatment without the sting
AU2002213441B2 (en) 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
CA2454587C (en) 2001-07-25 2012-11-13 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
CN1604788B (zh) 2001-10-16 2013-04-17 里克斯金蒂克斯公司 高浓度蛋白制剂及其制备方法
JP5290489B2 (ja) 2001-11-08 2013-09-18 アッヴィ・バイオセラピューティクス・インコーポレイテッド Ｉｇｇ抗体の安定な液体医薬製剤
WO2004001007A2 (en) 2002-06-21 2003-12-31 Idec Pharmaceuticals Corporation Buffered formulations for concentrating antibodies and methods of use thereof
US7041088B2 (en) 2002-10-11 2006-05-09 Ethicon, Inc. Medical devices having durable and lubricious polymeric coating
CN100361599C (zh) 2002-10-23 2008-01-16 克尔塞根控股有限公司 抗氧化组合物
AU2003293543A1 (en) 2002-12-13 2004-07-09 Abgenix, Inc. System and method for stabilizing antibodies with histidine
KR20040084168A (ko) 2003-03-26 2004-10-06 아미코젠주식회사 피니톨 또는 카이로이노시톨을 포함하는 간 질환 예방 및치료용 조성물
US20050158303A1 (en) 2003-04-04 2005-07-21 Genentech, Inc. Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations
CN1798575A (zh) 2003-04-04 2006-07-05 健泰科生物技术公司 高浓度抗体和蛋白制剂
DE10325198B4 (de) 2003-06-04 2007-10-25 Clariant Produkte (Deutschland) Gmbh Verwendung von alkoxylierten vernetzten Polyglycerinen als biologisch abbaubare Emulsionsspalter
EP1504671A1 (en) 2003-07-30 2005-02-09 Nestec S.A. Controlled delivery of caffeine from high-caffeinated coffee beverages made from soluble powder
CA2553542A1 (en) * 2003-10-31 2005-04-30 Robarts Research Institute Methods and formulations for protecting cells, and for treating diseases and conditions by optimizing the intracellular concentration of nad
EP1532983A1 (en) 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
US20050186183A1 (en) 2003-12-08 2005-08-25 Deangelo Joseph Stabilized products, processes and devices for preparing same
WO2006119054A2 (en) * 2005-04-29 2006-11-09 E. I. Du Pont De Nemours And Company Multi-step process for the manufacture of therapeutic protein
CN101584858A (zh) * 2005-12-20 2009-11-25 布里斯托尔-迈尔斯斯奎布公司 稳定蛋白质制剂
BRPI0620316A2 (pt) 2005-12-21 2011-11-08 Wyeth Corp formulações de proteìnas com viscosidades reduzida e seus usos
US8025915B2 (en) 2006-01-11 2011-09-27 Schott Ag Method of preparing a macromolecule deterrent surface on a pharmaceutical package
CA2638811A1 (en) 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
PL2001312T3 (pl) 2006-03-10 2014-10-31 Next Proteins Inc Sposób wytwarzania napoju białkowego
CN101442915A (zh) * 2006-03-10 2009-05-27 内克斯特蛋白质公司 蛋白饮料及其制备方法
TWI504597B (zh) 2006-03-16 2015-10-21 Pharmascience Inc 結合於細胞凋亡抑制蛋白（ｉａｐ）之桿狀病毒ｉａｐ重複序列（ｂｉｒ）區域之化合物
AU2007234612B2 (en) 2006-12-14 2013-06-27 Johnson & Johnson Regenerative Therapeutics, Llc Protein stabilization formulations
GB0700523D0 (en) 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
US7678764B2 (en) 2007-06-29 2010-03-16 Johnson & Johnson Regenerative Therapeutics, Llc Protein formulations for use at elevated temperatures
US8617568B2 (en) 2007-07-10 2013-12-31 Medy-Tox, Inc. Pharmaceutical liquid composition of botulinum toxin with improved stability
US20090047328A1 (en) 2007-08-16 2009-02-19 Peter Cunningham Caffeine delivery systems
EP2205280B1 (en) 2007-09-27 2019-09-04 Amgen Inc. Pharmaceutical formulations
CN101889209A (zh) * 2007-10-22 2010-11-17 贝克顿·迪金森公司 评价在含有机基聚硅氧烷的悬浮液中蛋白质聚集的方法和用含蛋白质溶液的有机基聚硅氧烷涂布的医疗制品
WO2009065126A2 (en) * 2007-11-16 2009-05-22 Boston Protein Solutions Excipients for protein stabilization
TWI543768B (zh) 2007-11-30 2016-08-01 艾伯維生物技術有限責任公司 蛋白質調配物及製造其之方法
EP2234636A4 (en) 2007-12-21 2013-05-15 Lyotropic Therapeutics Inc FORMULATIONS OF STABILIZED PEPTIDES AND PROTEINS
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
BRPI0911048A2 (pt) 2008-04-14 2015-12-29 Atrm Llc formulações líquidas tamponadas de gdf-5
WO2009141433A1 (en) * 2008-05-23 2009-11-26 Novo Nordisk Health Care Ag Low viscosity compositions comprising a pegylated gla-domain containing protein
AU2009347206C1 (en) 2008-10-20 2016-12-08 Abbvie Inc. Isolation and purification of antibodies using Protein A affinity chromatography
PT3778885T (pt) 2008-10-31 2023-05-31 Aerase Inc Composições de arginases humanas modificadas e métodos para o tratamento do cancro
CA2742817A1 (en) 2008-11-20 2010-05-27 Biogen Idec Ma Inc. Arginine inactivation of viruses
AR076640A1 (es) 2009-03-06 2011-06-29 Genentech Inc Formulacion con anticuerpo. metodo para estabilizar anticuerpo. articulo de manufactura
CA2766039A1 (en) 2009-06-29 2011-01-20 The Board Of Regents Of The University Of Texas System Arginase formulations and methods
MX2012003282A (es) 2009-09-17 2012-04-30 Baxter Healthcare Sa Co-formulacion estable de hialuronidasa e inmunoglobulina, y metodos de su uso.
EP2538974B1 (en) 2010-02-24 2018-04-18 Arecor Limited Protein formulations
BR112012021576A2 (pt) 2010-02-26 2016-10-25 Novo Nordisk As composições estáveis contendo anticorpo.
US9956165B2 (en) * 2010-03-01 2018-05-01 Cytodyn Inc. Concentrated protein formulations and uses thereof
WO2011109415A2 (en) 2010-03-02 2011-09-09 Amgen Inc. Reducing viscosity of pharmaceutical formulations
KR20130060227A (ko) * 2010-05-03 2013-06-07 제넨테크, 인크. 단백질-함유 제제의 점도 감소에 유용한 조성물 및 방법
SMT202000095T1 (it) * 2010-05-14 2020-03-13 Amgen Inc Formulazioni di anticorpi anti-sclerostina ad alta concentrazione
SG186783A1 (en) 2010-06-24 2013-02-28 Genentech Inc Compositions and methods containing alkylgycosides for stabilizing protein- containing formulations
JP5710311B2 (ja) 2011-02-18 2015-04-30 株式会社日立製作所 添加培地の添加制御方法、及び当該方法を用いた細胞培養装置
EP2683364B1 (en) 2011-03-10 2017-01-18 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of peptide drugs
HK1200718A1 (en) 2011-10-18 2015-08-14 科荣生生物科学公司 Etanercept formulations stabilized with sodium chloride
AU2012328524B2 (en) 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
RU2665810C2 (ru) 2011-10-31 2018-09-04 Дженентек, Инк. Содержащие антитела составы
NZ701915A (en) 2012-05-18 2016-11-25 Genentech Inc High-concentration monoclonal antibody formulations
SG10201606990TA (en) 2012-05-31 2016-10-28 Agency Science Tech & Res Methods for reducing levels of protein-contaminant complexes and aggregates in protein preparations by treatment with electropositive organic additives
EP2682168A1 (en) 2012-07-02 2014-01-08 Millipore Corporation Purification of biological molecules
US20140055254A1 (en) 2012-08-03 2014-02-27 Christopher Jack Adams Collision avoidance system for vehicles
US8613919B1 (en) 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
FR2995214B1 (fr) * 2012-09-10 2014-11-21 Adocia Solution a viscosite reduite de proteine a concentration elevee
JP6026002B2 (ja) 2012-11-27 2016-11-16 アルテオジェン インコーポレイテッド タンパク質とＦｃドメインを融合した融合タンパク質の安定化用組成物
MX350569B (es) 2012-12-03 2017-09-11 Landsteiner Scient S A De C V Composicion farmaceutica estable para el tratamiento de osteoporosis.
US20140342006A1 (en) 2013-03-15 2014-11-20 Ansun Biopharma, Inc. Methods for Preparing Injectable Protein Microparticle Suspensions
US9342374B2 (en) * 2013-06-28 2016-05-17 Dell Products, L.P. Method of scheduling threads for execution on multiple processors within an information handling system
IL312865B2 (en) * 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
WO2021072050A1 (en) 2019-10-08 2021-04-15 Reform Biologics, Llc Excipient compounds for protein formulations
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
WO2021108427A1 (en) 2019-11-26 2021-06-03 Reform Biologics, Llc Excipient compounds for biopolymer formulations
WO2020112855A1 (en) 2018-11-29 2020-06-04 Reform Biologics, Llc Excipient compounds for protein processing
EP3200804A4 (en) 2014-10-01 2018-04-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
CA2969974C (en) 2014-12-15 2020-08-04 The Regents Of The University Of Michigan Small molecule inhibitors of egfr and pi3k
US9649364B2 (en) 2015-09-25 2017-05-16 Xeris Pharmaceuticals, Inc. Methods for producing stable therapeutic formulations in aprotic polar solvents
EP4324482A2 (en) 2015-10-23 2024-02-21 Comera Life Sciences, Inc. Excipient compounds for biopolymer formulations
WO2018013673A1 (en) 2016-07-13 2018-01-18 Reform Biologics, Llc Stabilizing excipients for therapeutic protein formulations
JP2020507593A (ja) 2017-02-16 2020-03-12 リフォーム バイオロジクス、エルエルシー タンパク質処理用賦形剤化合物
CA3063324A1 (en) 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
WO2019036619A1 (en) 2017-08-18 2019-02-21 Reform Biologics, Llc STABILIZING EXCIPIENTS FOR FORMULATIONS OF THERAPEUTIC PROTEIN
EP3761962A4 (en) 2018-03-07 2021-12-15 ReForm Biologics, Inc. EXCIPIENT COMPOUNDS FOR PROTEIN-BASED FORMULATIONS
EP4210757A4 (en) 2020-09-11 2024-10-23 Comera Life Sciences, Inc. EXCELLENT COMPOUNDS FOR PROTEIN FORMULATIONS

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020105215A (ja) * 2014-06-20 2020-07-09 リフォーム バイオロジックス，エルエルシー タンパク質配合物のための粘度低減賦形剤化合物

Also Published As

Publication number Publication date
ES2965722T3 (es) 2024-04-16
JP2017519018A (ja) 2017-07-13
BR112016029906A2 (pt) 2017-08-22
US9605051B2 (en) 2017-03-28
EP4309643A2 (en) 2024-01-24
US20170157256A1 (en) 2017-06-08
KR20170023114A (ko) 2017-03-02
CN106535918B (zh) 2021-01-01
US11672865B2 (en) 2023-06-13
EP3160484B1 (en) 2023-09-20
JP2020105215A (ja) 2020-07-09
KR102463682B1 (ko) 2022-11-04
CA2951716A1 (en) 2015-12-23
BR112016029906A8 (pt) 2021-07-06
WO2015196091A1 (en) 2015-12-23
US20230028812A1 (en) 2023-01-26
US11660343B2 (en) 2023-05-30
US20160074515A1 (en) 2016-03-17
EP4309643A3 (en) 2024-04-10
US20160096879A1 (en) 2016-04-07
US9867881B2 (en) 2018-01-16
KR20220153668A (ko) 2022-11-18
CA2951716C (en) 2021-10-12
US20230381318A1 (en) 2023-11-30
EP3160484A1 (en) 2017-05-03
EP3160484A4 (en) 2017-12-20
WO2015196187A1 (en) 2015-12-23
US20190262455A1 (en) 2019-08-29
CN106535918A (zh) 2017-03-22
JP6983266B2 (ja) 2021-12-17

Similar Documents

Publication Publication Date Title
US11672865B2 (en) Viscosity-reducing excipient compounds for protein formulations
US11806399B2 (en) Excipient compounds for biopolymer formulations
CA3129181C (en) Excipient compounds for biopolymer formulations
JP2020507593A (ja) タンパク質処理用賦形剤化合物
US11357857B2 (en) Excipient compounds for protein processing
EP3886909A1 (en) Excipient compounds for protein processing
EP4065166A1 (en) Excipient compounds for biopolymer formulations

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180620

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20180620

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190212

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20190213

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190510

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20191021

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200121

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20200210

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20200309

R150 Certificate of patent or registration of utility model

Ref document number: 6674910

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

S531 Written request for registration of change of domicile

Free format text: JAPANESE INTERMEDIATE CODE: R313531

S533 Written request for registration of change of name

Free format text: JAPANESE INTERMEDIATE CODE: R313533

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350

S533 Written request for registration of change of name

Free format text: JAPANESE INTERMEDIATE CODE: R313533

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350

RD02 Notification of acceptance of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: R3D02

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

LAPS Cancellation because of no payment of annual fees