ES2965722T3 - Compuestos excipientes reductores de la viscosidad para formulaciones proteicas - Google Patents

Compuestos excipientes reductores de la viscosidad para formulaciones proteicas Download PDF

Info

Publication number
ES2965722T3
ES2965722T3 ES15809600T ES15809600T ES2965722T3 ES 2965722 T3 ES2965722 T3 ES 2965722T3 ES 15809600 T ES15809600 T ES 15809600T ES 15809600 T ES15809600 T ES 15809600T ES 2965722 T3 ES2965722 T3 ES 2965722T3
Authority
ES
Spain
Prior art keywords
formulation
therapeutic
viscosity
protein
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.)
Active
Application number
ES15809600T
Other languages
English (en)
Spanish (es)
Inventor
David S Soane
Philip Wuthrich
Rosa Casado Portilla
Robert P Mahoney
Mark Moody
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Comera Life Sciences Inc
Original Assignee
Comera Life Sciences Inc
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 Comera Life Sciences Inc filed Critical Comera Life Sciences Inc
Application granted granted Critical
Publication of ES2965722T3 publication Critical patent/ES2965722T3/es
Active 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 [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)

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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (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)
  • 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)
ES15809600T 2014-06-20 2015-06-22 Compuestos excipientes reductores de la viscosidad para formulaciones proteicas Active ES2965722T3 (es)

Applications Claiming Priority (4)

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

Publications (1)

Publication Number Publication Date
ES2965722T3 true ES2965722T3 (es) 2024-04-16

Family

ID=54936144

Family Applications (1)

Application Number Title Priority Date Filing Date
ES15809600T Active ES2965722T3 (es) 2014-06-20 2015-06-22 Compuestos excipientes reductores de la viscosidad para formulaciones proteicas

Country Status (9)

Country Link
US (6) US20160074515A1 (cg-RX-API-DMAC7.html)
EP (2) EP3160484B1 (cg-RX-API-DMAC7.html)
JP (2) JP6674910B2 (cg-RX-API-DMAC7.html)
KR (2) KR102463682B1 (cg-RX-API-DMAC7.html)
CN (1) CN106535918B (cg-RX-API-DMAC7.html)
BR (1) BR112016029906A8 (cg-RX-API-DMAC7.html)
CA (1) CA2951716C (cg-RX-API-DMAC7.html)
ES (1) ES2965722T3 (cg-RX-API-DMAC7.html)
WO (2) WO2015196091A1 (cg-RX-API-DMAC7.html)

Families Citing this family (38)

* 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
WO2019173338A1 (en) * 2018-03-07 2019-09-12 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
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
EP3200804A4 (en) 2014-10-01 2018-04-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
EP3365021A4 (en) * 2015-10-23 2019-06-05 Reform Biologics, LLC AUXILIARY COMPOUNDS FOR BIOPOLYMER FORMULATIONS
CA3030422C (en) 2016-07-13 2021-10-26 Reform Biologics, Llc Stabilizing excipients for therapeutic protein formulations
CA3254461A1 (en) * 2016-08-18 2025-07-03 Regeneron Pharmaceuticals, Inc. Assay for Determining Potential to Self-Association of a Protein Using Concentration-Dependent Self-Interaction Nanoparticle Spectroscopy
US11459401B2 (en) 2016-10-06 2022-10-04 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
JP7341061B2 (ja) 2016-11-22 2023-09-08 エレクトロファイ， インコーポレイテッド 治療用又は診断用薬剤を含む粒子並びにその懸濁液及び使用方法
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
WO2018200533A1 (en) 2017-04-28 2018-11-01 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
WO2018201064A1 (en) * 2017-04-28 2018-11-01 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
JP7382232B2 (ja) 2017-05-02 2023-11-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体の製剤および抗ｌａｇ３抗体と抗ｐｄ－１抗体との共製剤
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
SG11202000952PA (en) * 2017-08-03 2020-02-27 Jazz Pharmaceuticals Ireland Ltd Formulations comprising a nucleic acid in a high concentration
US20200206350A1 (en) 2017-09-05 2020-07-02 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
JP7465814B2 (ja) 2018-04-16 2024-04-11 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング 高濃度タンパク質製剤の粘度低下
US12115262B2 (en) 2018-05-24 2024-10-15 Elektrofi, Inc. Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
CN112969450B (zh) 2018-09-20 2023-05-30 阿卡蒂亚药品公司 卡贝缩宫素药物产品及用于制备其的方法
WO2020061414A1 (en) 2018-09-20 2020-03-26 Levo Therapeutics, Inc. Stable intranasal formulations of carbetocin
MX2021005394A (es) 2018-11-07 2021-07-06 Merck Sharp & Dohme Llc Co-formulaciones de anticuerpos anti-gen de activacion de linfocitos 3 (anti-lag3) y anticuerpos anti-muerte programada-1 (anti-pd-1).
EP3886909A4 (en) * 2018-11-29 2023-03-29 Comera Life Sciences, Inc. ADDITOR COMPOUNDS FOR PROTEIN PROCESSING
CN113365609A (zh) 2019-01-31 2021-09-07 伊勒卓菲公司 颗粒形成和形态
AU2020344675A1 (en) 2019-09-13 2022-03-31 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
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
JP2023533704A (ja) 2020-07-13 2023-08-04 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング 高濃度タンパク質製剤用の粘度低減賦形剤及びそれらの組み合わせ
WO2022217021A1 (en) * 2021-04-09 2022-10-13 Avantor Performance Materials, Llc Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations
JP2025504260A (ja) 2021-12-30 2025-02-07 バクスター・インターナショナル・インコーポレイテッド フィブリンシーラント用のフィブリノーゲン溶液及びトロンビン溶液並びにフィブリンシーラントキット
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
WO2024189048A1 (en) 2023-03-13 2024-09-19 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
US5262296A (en) 1988-03-30 1993-11-16 Toray Industries, Inc. Freeze-dried composition containing enzyme-labeled anti-human interferon-β antibody and enzyme immunoassay 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
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
CA2477857C (en) 1999-10-04 2012-04-10 Chiron Corporation Stabilized liquid polypeptide-containing pharmaceutical compositions
US20040081702A1 (en) * 2000-04-14 2004-04-29 Kim Christopher M. Bee venom treatment without the sting
EP1324776B2 (en) * 2000-10-12 2018-03-21 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US8703126B2 (en) * 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
ES2338218T3 (es) 2001-07-25 2010-05-05 Facet Biotech Corporation Formulacion farmacologica liofilizada estable de anticuerpos igg daclizumab.
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
US20030138417A1 (en) 2001-11-08 2003-07-24 Kaisheva Elizabet A. Stable liquid pharmaceutical formulation of IgG antibodies
AU2003251592A1 (en) 2002-06-21 2004-01-06 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
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
JP4869064B2 (ja) 2003-04-04 2012-02-01 ジェネンテック， インコーポレイテッド 高濃度抗体及びタンパク質製剤
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
US20090035275A1 (en) * 2003-10-31 2009-02-05 John Geoffrey Pickering 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
PT1962886E (pt) * 2005-12-20 2014-01-07 Bristol Myers Squibb Co Formulações de proteína estáveis
EP1962907A2 (en) 2005-12-21 2008-09-03 Wyeth a Corporation of the State of Delaware Protein formulations with reduced viscosity and uses thereof
US8025915B2 (en) 2006-01-11 2011-09-27 Schott Ag Method of preparing a macromolecule deterrent surface on a pharmaceutical package
WO2007092772A2 (en) 2006-02-03 2007-08-16 Medimmune, Inc. 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
MX2008011083A (es) 2006-03-10 2008-09-10 Next Proteins Inc Bebida proteinica y metodos para su elaboracion.
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
WO2009008595A1 (en) 2007-07-10 2009-01-15 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
ES2750254T3 (es) 2007-09-27 2020-03-25 Amgen Inc Formulaciones farmacéuticas
JP5081976B2 (ja) * 2007-10-22 2012-11-28 ベクトン・ディキンソン・アンド・カンパニー オルガノポリシロキサンを含む懸濁液においてタンパク質の凝集を評価するための方法
CN101795680A (zh) * 2007-11-16 2010-08-04 波苏蛋白试剂公司 稳定蛋白质的辅剂
TW200938221A (en) 2007-11-30 2009-09-16 Abbott Lab Protein formulations and methods of making same
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
CN102083459A (zh) * 2008-05-23 2011-06-01 诺沃-诺迪斯克保健股份有限公司 包括含有peg化的gla-结构域的蛋白质的低粘度组合物
EP2350127B1 (en) 2008-10-20 2015-01-28 AbbVie Inc. Isolation and purification of antibodies using protein a affinity chromatography
FI3778885T3 (fi) 2008-10-31 2023-05-23 Aerase Inc Muokattujen ihmisen arginaasien koostumuksia ja menetelmiä syövän hoitamiseksi
EP2350271B1 (en) 2008-11-20 2016-01-27 Biogen MA Inc. Arginine inactivation of enveloped viruses
BRPI1006519A2 (pt) 2009-03-06 2016-08-09 Genentech Inc formulação de anticorpos
WO2011008495A2 (en) 2009-06-29 2011-01-20 The Board Of Regents Of The University Of Texas System Arginase formulations and methods
DK2477603T3 (en) 2009-09-17 2016-06-13 Baxalta Inc STABLE CO-DEVELOPMENT OF hyaluronidase and Immunoglobulin, AND METHODS OF USE THEREOF
CA2790895C (en) 2010-02-24 2016-08-23 Jan Jezek Protein formulations
WO2011104381A2 (en) * 2010-02-26 2011-09-01 Novo Nordisk A/S Stable antibody containing compositions
JP5937523B2 (ja) * 2010-03-01 2016-06-22 サイトダイン インコーポレイテッドＣｙｔｏＤｙｎ， Ｉｎｃ． 濃縮されたタンパク質製剤およびその使用
WO2011109415A2 (en) 2010-03-02 2011-09-09 Amgen Inc. Reducing viscosity of pharmaceutical formulations
CA2794864A1 (en) * 2010-05-03 2011-11-10 Genentech, Inc. Compositions and methods useful for reducing the viscosity of protein-containing formulations
SMT202000095T1 (it) * 2010-05-14 2020-03-13 Amgen Inc Formulazioni di anticorpi anti-sclerostina ad alta concentrazione
KR102058307B1 (ko) 2010-06-24 2019-12-20 제넨테크, 인크. 단백질-함유 제제를 안정화시키기 위한 알킬글리코시드 함유 조성물 및 방법
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.
CN104010658A (zh) 2011-10-18 2014-08-27 科荣生生物科学公司 使用葡甲胺稳定的依那西普制剂
BR112014010186A2 (pt) 2011-10-28 2017-05-02 Integritybio Inc formulação farmacêutica estável, kit, composição farmacêutica, método para preparar uma formulação farmacêutica, e, método para tratar um humano ou animal
CN116077644A (zh) 2011-10-31 2023-05-09 弗·哈夫曼-拉罗切有限公司 抗体制剂
CN104427974B (zh) 2012-05-18 2018-03-23 基因泰克公司 高浓度单克隆抗体配制剂
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
EP2926834A4 (en) 2012-11-27 2016-04-20 Alteogen Inc COMPOSITION FOR STABILIZING A FUSION PROTEIN IN WHICH A PROTEIN AND A DOMAIN FC ARE MERGED
MX350569B (es) 2012-12-03 2017-09-11 Landsteiner Scient S A De C V Composicion farmaceutica estable para el tratamiento de osteoporosis.
WO2014151705A1 (en) 2013-03-15 2014-09-25 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
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
WO2021072050A1 (en) 2019-10-08 2021-04-15 Reform Biologics, Llc Excipient compounds for protein formulations
WO2019173338A1 (en) 2018-03-07 2019-09-12 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
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. 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
CA3081443A1 (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
EP3365021A4 (en) 2015-10-23 2019-06-05 Reform Biologics, LLC AUXILIARY COMPOUNDS FOR BIOPOLYMER FORMULATIONS
CA3030422C (en) 2016-07-13 2021-10-26 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
EP3886909A4 (en) 2018-11-29 2023-03-29 Comera Life Sciences, Inc. ADDITOR COMPOUNDS FOR PROTEIN PROCESSING
EP4065166A4 (en) 2019-11-26 2023-12-20 Comera Life Sciences, Inc. EXCIPIENT COMPOUNDS FOR BIOPOLYMER FORMULATIONS
EP4210757A4 (en) 2020-09-11 2024-10-23 Comera Life Sciences, Inc. EXCELLENT COMPOUNDS FOR PROTEIN FORMULATIONS

Also Published As

Publication number Publication date
US20190262455A1 (en) 2019-08-29
CA2951716A1 (en) 2015-12-23
US20170157256A1 (en) 2017-06-08
US20230028812A1 (en) 2023-01-26
CA2951716C (en) 2021-10-12
US9605051B2 (en) 2017-03-28
KR20220153668A (ko) 2022-11-18
US20230381318A1 (en) 2023-11-30
EP3160484A4 (en) 2017-12-20
JP2017519018A (ja) 2017-07-13
US9867881B2 (en) 2018-01-16
US20160096879A1 (en) 2016-04-07
JP6983266B2 (ja) 2021-12-17
KR102463682B1 (ko) 2022-11-04
EP4309643A3 (en) 2024-04-10
EP4309643A2 (en) 2024-01-24
JP6674910B2 (ja) 2020-04-01
WO2015196091A1 (en) 2015-12-23
EP3160484A1 (en) 2017-05-03
CN106535918A (zh) 2017-03-22
BR112016029906A2 (pt) 2017-08-22
US11660343B2 (en) 2023-05-30
US11672865B2 (en) 2023-06-13
WO2015196187A1 (en) 2015-12-23
BR112016029906A8 (pt) 2021-07-06
JP2020105215A (ja) 2020-07-09
CN106535918B (zh) 2021-01-01
EP3160484B1 (en) 2023-09-20
US20160074515A1 (en) 2016-03-17
KR20170023114A (ko) 2017-03-02

Similar Documents

Publication Publication Date Title
ES2965722T3 (es) Compuestos excipientes reductores de la viscosidad para formulaciones proteicas
US11806399B2 (en) Excipient compounds for biopolymer formulations
CA3129181C (en) Excipient compounds for biopolymer formulations
KR20190117631A (ko) 단백질 가공 처리를 위한 부형제 화합물
EP3886909A1 (en) Excipient compounds for protein processing
US20210379185A1 (en) Excipient compounds for protein processing
US20230027396A1 (en) Excipient compounds for biopolymer formulations
CA3159377A1 (en) Excipient compounds for biopolymer formulations