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 (enExample
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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Mycology (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 (enExample) 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 (enExample)
EP (2) EP3160484B1 (enExample)
JP (2) JP6674910B2 (enExample)
KR (2) KR102463682B1 (enExample)
CN (1) CN106535918B (enExample)
BR (1) BR112016029906A8 (enExample)
CA (1) CA2951716C (enExample)
ES (1) ES2965722T3 (enExample)
WO (2) WO2015196091A1 (enExample)

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
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
JP6716577B2 (ja) 2014-10-01 2020-07-01 イーグル・バイオロジクス・インコーポレイテッドＥａｇｌｅ Ｂｉｏｌｏｇｉｃｓ， Ｉｎｃ． 粘度低下物質を含有する、多糖および核酸の調合薬
CA3129181C (en) * 2015-10-23 2023-10-31 Reform Biologics, Llc Excipient compounds for biopolymer formulations
CA3030422C (en) 2016-07-13 2021-10-26 Reform Biologics, Llc Stabilizing excipients for therapeutic protein formulations
HUE066064T2 (hu) 2016-08-18 2024-07-28 Regeneron Pharma Fehérje önasszociációs képességének meghatározására szolgáló assay koncentrációfüggõ öninterakciós nanorészecske-spektroszkópia segítségével
WO2018067987A1 (en) * 2016-10-06 2018-04-12 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
AU2017364077A1 (en) 2016-11-22 2019-06-20 Elektrofi, Inc. Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
CA3053909A1 (en) * 2017-02-16 2018-08-23 Reform Biologics, Llc Excipient compounds for protein processing
ES3036143T3 (en) * 2017-04-28 2025-09-15 Amgen Inc N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
WO2018200533A1 (en) 2017-04-28 2018-11-01 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
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
EP3658612A4 (en) 2017-07-25 2021-06-02 Elektrofi, Inc. FORMATION OF PARTICLES WITH SUBSTANCES
WO2019028340A1 (en) * 2017-08-03 2019-02-07 Jazz Pharmaceuticals Ireland Limited FORMULATIONS COMPRISING A HIGH CONCENTRATION NUCLEIC ACID
CN111107873A (zh) 2017-09-05 2020-05-05 默沙东公司 用于降低生物制剂粘度的化合物
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
CN112040931A (zh) * 2018-03-07 2020-12-04 改进生物制品有限责任公司 用于蛋白质制剂的赋形剂化合物
WO2019201904A1 (en) * 2018-04-16 2019-10-24 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
CN112839632A (zh) 2018-09-20 2021-05-25 莱沃疗法公司 稳定的鼻内卡贝缩宫素制剂
AU2019345313A1 (en) 2018-09-20 2021-03-18 Levo Therapeutics, Inc. Carbetocin drug product and process for preparing same
JP7467438B2 (ja) 2018-10-18 2024-04-15 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｒｓｖ抗体の製剤及びその使用方法
CN113015748B (zh) 2018-10-31 2025-12-12 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
CA3120023A1 (en) * 2018-11-29 2020-06-04 Reform Biologics, Llc Excipient compounds for protein processing
WO2020160323A2 (en) 2019-01-31 2020-08-06 Elektrofi, Inc. Particle formation and morphology
JP7781743B2 (ja) 2019-09-13 2025-12-08 エレクトロフィ，インコーポレイテッド 疾患の処置のための治療用生物学的作用剤の送達のための組成物及び方法
CA3159377A1 (en) * 2019-11-26 2021-06-03 David S. Soane Excipient compounds for biopolymer formulations
CN115484934A (zh) 2020-04-17 2022-12-16 伊勒卓菲公司 通过连续液滴形成和脱水形成颗粒的方法
BR112022026670A2 (pt) 2020-07-13 2023-01-24 Merck Patent Gmbh Excipientes de redução da viscosidade e combinações dos mesmos para formulações de proteína 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
CN118401262A (zh) 2021-12-30 2024-07-26 巴克斯特国际公司 用于纤维蛋白密封剂的纤维蛋白原和凝血酶溶液以及纤维蛋白密封剂试剂盒
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
EP4680285A1 (en) 2023-03-13 2026-01-21 Heidelberg Pharma Research GmbH Subcutaneously administered antibody-drug conjugates for use in cancer treatment
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
EP0365685B1 (en) 1988-03-30 1995-01-18 Toray Industries, Inc. Freeze-dried composition comprising a horseradish peroxidase-labelled Fab' fragment of an anti-human interferon-beta monclonal antibody and trehalose; EIA kit containing the composition
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
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US6267958B1 (en) 1995-07-27 2001-07-31 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
ATE464062T1 (de) 1999-10-04 2010-04-15 Novartis Vaccines & Diagnostic Stabilisierte flüssige pharmazeutische zusammensetzung enthaltend tfpi
US20040081702A1 (en) * 2000-04-14 2004-04-29 Kim Christopher M. Bee venom treatment without the sting
US8703126B2 (en) * 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
PT1324776E (pt) * 2000-10-12 2009-12-23 Genentech Inc Formulações de proteína concentradas de viscosidade reduzida
WO2003009817A2 (en) 2001-07-25 2003-02-06 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
IL161677A0 (en) 2001-11-08 2004-09-27 Protein Design Labs Stable liquid pharmaceutical formulation of igg antibodies
CA2490423A1 (en) 2002-06-21 2003-12-31 Biogen Idec Inc. 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
HRP20050934B1 (hr) 2003-04-04 2014-09-26 Genentech, Inc. Formulacije s visokom koncentracijom antitijela i proteina
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
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
EP1727546A4 (en) * 2003-10-31 2008-07-09 Robarts Res Inst METHOD AND FORMULATIONS FOR THE PROTECTION OF CELLS AND FOR THE TREATMENT OF ILLNESSES AND SUFFERING THROUGH OPTIMIZATION OF INTRA-CELLULAR NAD CONCENTRATION
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
JP2008538929A (ja) * 2005-04-29 2008-11-13 イー・アイ・デュポン・ドウ・ヌムール・アンド・カンパニー 治療用タンパク質を製造するための多段階方法
TW200738261A (en) * 2005-12-20 2007-10-16 Bristol Myers Squibb Co Stable protein formulations
CN101378782A (zh) 2005-12-21 2009-03-04 惠氏公司 粘度降低的蛋白质制剂及其用途
US8025915B2 (en) 2006-01-11 2011-09-27 Schott Ag Method of preparing a macromolecule deterrent surface on a pharmaceutical package
AU2007212147A1 (en) 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
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
CA2645490C (en) 2006-03-10 2015-01-27 Next Proteins, Inc. Protein drink and method of making same
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
RU2440825C2 (ru) 2007-07-10 2012-01-27 Меди-Токс, Инк. Жидкая фармацевтическая композиция ботулинического токсина
US20090047328A1 (en) * 2007-08-16 2009-02-19 Peter Cunningham Caffeine delivery systems
WO2009043049A2 (en) 2007-09-27 2009-04-02 Amgen Inc. Pharmaceutical formulations
CN106443002A (zh) * 2007-10-22 2017-02-22 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
US8642532B2 (en) * 2007-11-16 2014-02-04 Guohan Yang Excipients for protein stabilization
NZ622583A (en) 2007-11-30 2015-08-28 Abbvie Biotechnology Ltd Protein formulations and methods of making same
AU2008343052A1 (en) 2007-12-21 2009-07-09 Lyotropic Therapeutics, Inc. Stabilized formulations of peptides and proteins
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
WO2009129101A1 (en) 2008-04-14 2009-10-22 Advanced Technologies And Regenerative Medicine, Llc Liquid buffered gdf-5 formulations
US20110112029A1 (en) * 2008-05-23 2011-05-12 Novo Nordisk Health Care Ag Low viscosity compositions comprising a pegylated gla-domain containing protein
TWI610936B (zh) 2008-10-20 2018-01-11 艾伯維有限公司 使用蛋白質ａ親和性層析進行抗體之分離及純化
SI3778885T1 (sl) 2008-10-31 2023-07-31 Aerase, Inc. Sestavki inženirskih humanih arginaz in metode za zdravljenje raka
CA2742817A1 (en) 2008-11-20 2010-05-27 Biogen Idec Ma Inc. Arginine inactivation of viruses
AU2010221156A1 (en) 2009-03-06 2011-09-22 Genentech, Inc. Antibody formulation
JP2012531893A (ja) 2009-06-29 2012-12-13 ボード・オブ・リージエンツ，ザ・ユニバーシテイ・オブ・テキサス・システム アルギナーゼ製剤および方法
HRP20160530T1 (hr) 2009-09-17 2016-07-29 Baxalta Incorporated Stabilna ko-formulacija hijaluronidaze i imunoglobulina, te postupci njezine uporabe
CA2790895C (en) 2010-02-24 2016-08-23 Jan Jezek Protein formulations
CN107496917B (zh) 2010-02-26 2021-06-11 诺沃—诺迪斯克有限公司 包含稳定抗体的组合物
BR112012022223B1 (pt) * 2010-03-01 2022-08-09 Cytodyn Inc Formulação de proteína concentrada, uso e método de preparação da mesma
WO2011109415A2 (en) 2010-03-02 2011-09-09 Amgen Inc. Reducing viscosity of pharmaceutical formulations
RU2012151500A (ru) * 2010-05-03 2014-06-10 Дженентек, Инк. Композиции и способы, пригодные для снижения вязкости белковосодержащих составов
SMT202000095T1 (it) * 2010-05-14 2020-03-13 Amgen Inc Formulazioni di anticorpi anti-sclerostina ad alta concentrazione
MY184736A (en) 2010-06-24 2021-04-20 Genentech Inc Compositions and methods containing alkylglycosides 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
MX342675B (es) 2011-03-10 2016-10-07 Xeris Pharmaceuticals Inc Formulaciones estables para inyeccion parenteral de farmacos de peptido.
CN104011073B (zh) 2011-10-18 2017-08-25 科荣生生物科学公司 使用氨基酸稳定的依那西普制剂
CN104023748B (zh) 2011-10-28 2018-03-02 诚信生物公司 含有氨基酸的蛋白质制剂
LT3091029T (lt) 2011-10-31 2023-02-27 F. Hoffmann-La Roche Ag Anti-il13 antikūno kompozicijos
AU2013262611B2 (en) 2012-05-18 2018-03-01 Genentech, Inc. High-concentration monoclonal antibody formulations
KR102067445B1 (ko) 2012-05-31 2020-01-17 에이전시 포 사이언스, 테크놀로지 앤드 리서치 양전하 유기 첨가물 처리에 의한 단백질-오염물 복합체 및 단백질 제제 내 응집체 레벨의 감소 방법
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
US9474803B2 (en) 2012-11-27 2016-10-25 Alteogen Inc. Composition for stabilizing fusion protein in which protein and FC domain are fused
MX350569B (es) 2012-12-03 2017-09-11 Landsteiner Scient S A De C V Composicion farmaceutica estable para el tratamiento de osteoporosis.
HK1220120A1 (zh) 2013-03-15 2017-04-28 Ansun Biopharma, Inc. 制造注射蛋白质微粒悬浮液的方法
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
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
WO2021072050A1 (en) 2019-10-08 2021-04-15 Reform Biologics, Llc Excipient compounds for protein formulations
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
JP6716577B2 (ja) 2014-10-01 2020-07-01 イーグル・バイオロジクス・インコーポレイテッドＥａｇｌｅ Ｂｉｏｌｏｇｉｃｓ， Ｉｎｃ． 粘度低下物質を含有する、多糖および核酸の調合薬
WO2016100347A2 (en) 2014-12-15 2016-06-23 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
CA3129181C (en) 2015-10-23 2023-10-31 Reform Biologics, Llc Excipient compounds for biopolymer formulations
CA3030422C (en) 2016-07-13 2021-10-26 Reform Biologics, Llc Stabilizing excipients for therapeutic protein formulations
CA3053909A1 (en) 2017-02-16 2018-08-23 Reform Biologics, Llc Excipient compounds for protein processing
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
CN112040931A (zh) 2018-03-07 2020-12-04 改进生物制品有限责任公司 用于蛋白质制剂的赋形剂化合物
CA3120023A1 (en) 2018-11-29 2020-06-04 Reform Biologics, Llc Excipient compounds for protein processing
CA3159377A1 (en) 2019-11-26 2021-06-03 David S. Soane Excipient compounds for biopolymer formulations
US20250186600A1 (en) 2020-09-11 2025-06-12 Comera Life Sciences, Inc. Excipient 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
JP2020105215A (ja) 2020-07-09
CN106535918A (zh) 2017-03-22
JP2017519018A (ja) 2017-07-13
US20190262455A1 (en) 2019-08-29
CA2951716A1 (en) 2015-12-23
US20160074515A1 (en) 2016-03-17
US11660343B2 (en) 2023-05-30
BR112016029906A8 (pt) 2021-07-06
CA2951716C (en) 2021-10-12
ES2965722T3 (es) 2024-04-16
US20170157256A1 (en) 2017-06-08
US20160096879A1 (en) 2016-04-07
CN106535918B (zh) 2021-01-01
JP6983266B2 (ja) 2021-12-17
EP3160484B1 (en) 2023-09-20
US20230381318A1 (en) 2023-11-30
EP3160484A1 (en) 2017-05-03
KR102463682B1 (ko) 2022-11-04
BR112016029906A2 (pt) 2017-08-22
WO2015196091A1 (en) 2015-12-23
WO2015196187A1 (en) 2015-12-23
KR20170023114A (ko) 2017-03-02
US9867881B2 (en) 2018-01-16
US11672865B2 (en) 2023-06-13
EP4309643A2 (en) 2024-01-24
US9605051B2 (en) 2017-03-28
EP4309643A3 (en) 2024-04-10
EP3160484A4 (en) 2017-12-20
KR20220153668A (ko) 2022-11-18
US20230028812A1 (en) 2023-01-26

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