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

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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
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formulation
protein
viscosity
therapeutic
excipient
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JP2017519018A5 (OSRAM
JP2017519018A (ja
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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
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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
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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
    • 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 [IGs], 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)

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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)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (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)
  • 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

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JP2017519018A JP2017519018A (ja) 2017-07-13
JP2017519018A5 JP2017519018A5 (OSRAM) 2018-08-02
JP6674910B2 true JP6674910B2 (ja) 2020-04-01

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US (6) US20160074515A1 (OSRAM)
EP (2) EP3160484B1 (OSRAM)
JP (2) JP6674910B2 (OSRAM)
KR (2) KR20220153668A (OSRAM)
CN (1) CN106535918B (OSRAM)
BR (1) BR112016029906A8 (OSRAM)
CA (1) CA2951716C (OSRAM)
ES (1) ES2965722T3 (OSRAM)
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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 (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
WO2016054259A1 (en) 2014-10-01 2016-04-07 Arsia Therapeutics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
CA3002373A1 (en) * 2015-10-23 2017-04-27 Reform Biologics, Llc Excipient compounds for biopolymer formulations
JP2019527729A (ja) 2016-07-13 2019-10-03 リフォーム バイオロジクス、エルエルシー 治療用タンパク質製剤のための安定化賦形剤
MX2019001930A (es) * 2016-08-18 2019-07-04 Regeneron Pharma Ensayo para determinar el potencial para la autoasociacion de una proteina usando espectroscopia de nanoparticulas de autointeraccion dependiente de la concentracion.
WO2018067987A1 (en) * 2016-10-06 2018-04-12 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
EP3544724A4 (en) 2016-11-22 2020-10-14 Elektrofi, Inc PARTICLES INCLUDING A THERAPEUTIC OR DIAGNOSTIC AGENT AND SUSPENSIONS AND THEIR METHODS OF USE
KR102572453B1 (ko) * 2017-02-16 2023-08-29 코메라 라이프 사이언시스, 인코포레이티드 단백질 가공 처리를 위한 부형제 화합물
AU2018258676B2 (en) * 2017-04-28 2024-09-19 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
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CA3060581A1 (en) 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
CA3063324A1 (en) * 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
WO2019023392A1 (en) 2017-07-25 2019-01-31 Elektrofi, Inc. FORMATION OF PARTICLES COMPRISING AGENTS
CN111132663A (zh) * 2017-08-03 2020-05-08 爵士制药爱尔兰有限公司 包含高浓度核酸的制剂
RU2020112302A (ru) 2017-09-05 2021-10-06 Мерк Шарп И Доум Корп. Соединения для уменьшения вязкости биологических композиций
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
CN111989121B (zh) 2018-04-16 2024-08-13 默克专利股份有限公司 高浓缩蛋白质制剂的粘度降低
US12115262B2 (en) 2018-05-24 2024-10-15 Elektrofi, Inc. Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
AU2019345166B2 (en) 2018-09-20 2021-09-02 Levo Therapeutics, Inc. Stable intranasal formulations of carbetocin
JP7538802B2 (ja) 2018-09-20 2024-08-22 アカディア ファーマシューティカルズ インコーポレイテッド カルベトシン医薬品およびその製造プロセス
BR112021008873A8 (pt) 2018-11-07 2023-04-11 Merck Sharp & Dohme Formulação
KR20210096633A (ko) * 2018-11-29 2021-08-05 리폼 바이오로직스, 엘엘씨 단백질 처리를 위한 부형제 화합물
WO2020160323A2 (en) 2019-01-31 2020-08-06 Elektrofi, Inc. Particle formation and morphology
EP4027978A1 (en) 2019-09-13 2022-07-20 Elektrofi, Inc. Compositions and methods for the delivery of therapeutic biologics for treatment of disease
EP4065166A4 (en) * 2019-11-26 2023-12-20 Comera Life Sciences, Inc. EXCIPIENT COMPOUNDS FOR BIOPOLYMER FORMULATIONS
US12377050B2 (en) 2020-04-17 2025-08-05 Elektrofi, Inc. Methods of forming particles by continuous droplet formation and dehydration
CN115803011A (zh) 2020-07-13 2023-03-14 默克专利股份有限公司 用于高度浓缩蛋白质制剂的粘度降低赋形剂及其组合
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
KR20240125667A (ko) 2021-12-30 2024-08-19 백스터 인터내셔널 인코포레이티드 피브린 실란트용 피브리노겐 및 트롬빈 용액 및 피브린 실란트 키트
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
KR20250152101A (ko) 2023-03-13 2025-10-22 하이델베르크 파마 리서치 게엠베하 암 치료에의 사용을 위한 피하 투여 항체-약물 접합체
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
ATE117434T1 (de) 1988-03-30 1995-02-15 Toray Industries Gefriergetrocknete zusammensetzung, die ein mit meerrettichperoxydase markiertes fab'-fragment eines gegen menschliches beta-interferon gerichteten antikörpers und trehalose enthält; eia kit, der diese zusammensetzung enthält.
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
CN1245216C (zh) 1999-10-04 2006-03-15 希龙公司 稳定化的含多肽的液体药物组合物
US20040081702A1 (en) * 2000-04-14 2004-04-29 Kim Christopher M. Bee venom treatment without the sting
JP4340062B2 (ja) 2000-10-12 2009-10-07 ジェネンテック・インコーポレーテッド 粘度の減少した濃縮タンパク質製剤
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US20030113316A1 (en) 2001-07-25 2003-06-19 Kaisheva Elizabet A. Stable lyophilized pharmaceutical formulation of IgG antibodies
JP2005523882A (ja) 2001-10-16 2005-08-11 アールエックスキネティックス，インコーポレイテッド 高濃度タンパク質製剤および製造の方法
EP1441589B1 (en) 2001-11-08 2012-05-09 Abbott Biotherapeutics Corp. Stable liquid pharmaceutical formulation of igg antibodies
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
WO2004055164A2 (en) 2002-12-13 2004-07-01 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
EP2335725B1 (en) 2003-04-04 2016-10-12 Genentech, Inc. High concentration antibody and protein 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
EP1874916A2 (en) * 2005-04-29 2008-01-09 E.I. Dupont De Nemours And Company Multi-step process for the manufacture of therapeutic protein
PE20071063A1 (es) 2005-12-20 2007-10-24 Bristol Myers Squibb Co Formulaciones de proteinas estables
JP5405122B2 (ja) 2005-12-21 2014-02-05 ワイス・エルエルシー 低粘度のタンパク質製剤およびその用途
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
CN105124676A (zh) 2006-03-10 2015-12-09 内克斯特蛋白质公司 蛋白饮料及其制备方法
TWI543988B (zh) 2006-03-16 2016-08-01 科學製藥股份有限公司 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
BRPI0813948B8 (pt) 2007-07-10 2021-05-25 Medy Tox Inc composição líquida farmacêutica de toxina botulínica com estabilidade melhorada
US20090047328A1 (en) * 2007-08-16 2009-02-19 Peter Cunningham Caffeine delivery systems
ES2750254T3 (es) 2007-09-27 2020-03-25 Amgen Inc Formulaciones farmacéuticas
EP2237038B1 (en) * 2007-10-22 2015-04-29 Becton Dickinson and Company Medical articles coated with organopolysiloxane containing a protein solution and non-ionic surfactant
WO2009065126A2 (en) * 2007-11-16 2009-05-22 Boston Protein Solutions Excipients for protein stabilization
RU2473360C2 (ru) 2007-11-30 2013-01-27 Эббот Лэборетриз Белковые композиции и способы их получения
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
US7947649B2 (en) 2008-04-14 2011-05-24 Advanced Technologies And Regenerative Medicine, Llc Liquid buffered GDF-5 formulations
WO2009141433A1 (en) * 2008-05-23 2009-11-26 Novo Nordisk Health Care Ag Low viscosity compositions comprising a pegylated gla-domain containing protein
JP5808249B2 (ja) 2008-10-20 2015-11-10 アッヴィ・インコーポレイテッド プロテインａアフィニティークロマトグラフィーを用いる抗体の単離および精製
PT3778885T (pt) 2008-10-31 2023-05-31 Aerase Inc Composições de arginases humanas modificadas e métodos para o tratamento do cancro
JP5730211B2 (ja) 2008-11-20 2015-06-03 バイオジェン アイデック エムエー インコーポレイティドＢｉｏｇｅｎ Ｉｄｅｃ Ｉｎｃ． ウイルスのアルギニン不活化
SG174258A1 (en) 2009-03-06 2011-10-28 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
CN102655853B (zh) 2009-09-17 2015-07-29 巴克斯特卫生保健有限公司 透明质酸酶和免疫球蛋白的稳定的复合制剂及其使用方法
EP2538974B1 (en) 2010-02-24 2018-04-18 Arecor Limited Protein formulations
EP3216462A3 (en) * 2010-02-26 2017-12-20 Novo Nordisk A/S Stable antibody containing compositions
KR101853981B1 (ko) * 2010-03-01 2018-05-02 사이토딘 인크. 농축 단백질 제형물 및 그의 용도
US20130171128A1 (en) 2010-03-02 2013-07-04 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
CA2802756C (en) 2010-06-24 2021-05-04 Genentech, Inc. Compositions and methods 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
BR112013023062B1 (pt) 2011-03-10 2022-01-18 Xeris Pharmaceuticals, Inc Solução estável para a injeção parenteral e método de fabricação da mesma
KR20140079491A (ko) 2011-10-18 2014-06-26 코히러스 바이오사이언시즈, 인코포레이티드 당과 폴리올과의 배합물로 안정화된 에타너셉트 제형
WO2013063510A1 (en) 2011-10-28 2013-05-02 Integritybio Inc. Protein formulations containing amino acids
EP2773662A4 (en) 2011-10-31 2015-07-01 Hoffmann La Roche ANTIBODY FORMULATIONS
NZ701915A (en) 2012-05-18 2016-11-25 Genentech Inc High-concentration monoclonal antibody formulations
EP2855502B1 (en) 2012-05-31 2019-06-26 Agency For Science, Technology And Research 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
KR101419884B1 (ko) 2012-11-27 2014-07-16 (주)알테오젠 단백질과 Fc 도메인을 융합한 융합 단백질의 안정화용 조성물
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
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
US20160074515A1 (en) * 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
WO2016054259A1 (en) 2014-10-01 2016-04-07 Arsia Therapeutics, 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
CA3002373A1 (en) 2015-10-23 2017-04-27 Reform Biologics, Llc Excipient compounds for biopolymer formulations
JP2019527729A (ja) 2016-07-13 2019-10-03 リフォーム バイオロジクス、エルエルシー 治療用タンパク質製剤のための安定化賦形剤
KR102572453B1 (ko) 2017-02-16 2023-08-29 코메라 라이프 사이언시스, 인코포레이티드 단백질 가공 처리를 위한 부형제 화합물
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
KR20210096633A (ko) 2018-11-29 2021-08-05 리폼 바이오로직스, 엘엘씨 단백질 처리를 위한 부형제 화합물
EP4065166A4 (en) 2019-11-26 2023-12-20 Comera Life Sciences, Inc. EXCIPIENT COMPOUNDS FOR BIOPOLYMER FORMULATIONS
WO2022056220A2 (en) 2020-09-11 2022-03-17 Reform Biologics, 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

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