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 [IG], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2462—Lysozyme (3.2.1.17)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01017—Lysozyme (3.2.1.17)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • 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)
  • 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)
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 (enExample)
EP (2) EP4309643A3 (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)

Families Citing this family (41)

* 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
WO2015196091A1 (en) * 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
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
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog Inc Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
WO2017070501A1 (en) * 2015-10-23 2017-04-27 Reform Biologics, Llc Excipient compounds for biopolymer formulations
WO2018013673A1 (en) 2016-07-13 2018-01-18 Reform Biologics, Llc Stabilizing excipients for therapeutic protein formulations
EA201990316A1 (ru) * 2016-08-18 2019-07-31 Ридженерон Фармасьютикалз, Инк. Анализ для определения потенциала самоассоциации белка с использованием концентрационно-зависимой спектроскопии самовзаимодействия на основе наночастиц
JP7275027B2 (ja) * 2016-10-06 2023-05-17 アムジェン インコーポレイテッド 粘度低下タンパク質医薬製剤
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
MA48461A (fr) 2017-04-28 2020-03-04 Amgen Inc Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation
US12103979B2 (en) * 2017-04-28 2024-10-01 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
CN110913906A (zh) 2017-05-02 2020-03-24 默沙东公司 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
US10646569B2 (en) * 2017-05-16 2020-05-12 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
EP3678700B1 (en) 2017-09-05 2024-06-19 Merck Sharp & Dohme LLC 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
JP7256816B2 (ja) * 2018-03-07 2023-04-12 コメラ ライフ サイエンシズ，インコーポレイテッド タンパク質製剤用の賦形剤化合物
AU2019254483B2 (en) * 2018-04-16 2025-02-27 Merck Patent Gmbh Viscosity reduction of highly concentrated protein formulations
WO2019226969A1 (en) 2018-05-24 2019-11-28 Elektrofi, Inc. Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
US20200093884A1 (en) 2018-09-20 2020-03-26 Mark C. Manning Stable intranasal formulations of carbetocin
EP3852724A4 (en) 2018-09-20 2022-07-06 Levo Therapeutics, Inc. CARBETOCIN DRUG PRODUCT AND PROCESS FOR ITS MANUFACTURE
MX2021004356A (es) 2018-10-18 2021-05-31 Merck Sharp & Dohme Llc Formulaciones de anticuerpos anti-rsv y metodos de uso de las mismas.
MA54089A (fr) 2018-10-31 2022-02-09 Merck Sharp & Dohme Anticorps anti-pd-1 humain et procédés d'utilisation associés
JP7503056B6 (ja) 2018-11-07 2024-07-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体および抗ｐｄ－１抗体の共－製剤
CA3120023A1 (en) * 2018-11-29 2020-06-04 Reform Biologics, Llc Excipient compounds for protein processing
AU2020214626B2 (en) 2019-01-31 2025-10-16 Halozyme Hypercon, Inc. Particle formation and morphology
AU2020344675B2 (en) 2019-09-13 2026-06-25 Halozyme Hypercon, 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
CA3187322A1 (en) 2020-07-13 2022-01-20 Merck Patent Gmbh Viscosity reducing excipients and combinations thereof for highly concentrated protein formulations
CA3214867A1 (en) * 2021-04-09 2022-10-13 Courtney O'DELL Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations
EP4456935A1 (en) 2021-12-30 2024-11-06 Baxter International Inc. Fibrinogen and thrombin solutions for a fibrin sealant and fibrin sealant kit
WO2023217813A2 (en) * 2022-05-12 2023-11-16 Merck Patent Gmbh Excipients for purification and virus filtration of biological fluids
KR20230167968A (ko) * 2022-06-03 2023-12-12 주식회사 녹십자홀딩스 점도 감소 부형제 조성물 및 이를 포함하는 저점도 고농축 단백질 제형
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
DE68920693T2 (de) 1988-03-30 1995-05-24 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
CZ305123B6 (cs) 1999-10-04 2015-05-13 Novartis Vaccines And Diagnostics, Inc. Způsob výroby kapalného farmaceutického prostředku
US20040081702A1 (en) * 2000-04-14 2004-04-29 Kim Christopher M. Bee venom treatment without the sting
DE60139944D1 (de) 2000-10-12 2009-10-29 Genentech Inc Niederviskose konzentrierte proteinformulierungen
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
ATE454137T1 (de) 2001-07-25 2010-01-15 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers 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
PT1610820E (pt) 2003-04-04 2010-12-16 Novartis Ag Formulações de elevada concentração de anticorpos e proteínas
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
WO2006072809A2 (en) * 2003-10-31 2006-07-13 Robarts Research Institute Formulations that optimize intracellular concentration of nicotinamide adenine (nad+) and methods of use to protect cells and treat diseases and conditions
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
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
JP2009525986A (ja) 2006-02-03 2009-07-16 メディミューン，エルエルシー タンパク質製剤
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
NZ570558A (en) 2006-03-10 2012-06-29 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
CA2690773C (en) 2007-07-10 2013-09-17 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
AU2008304111B2 (en) 2007-09-27 2014-04-24 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
CN101795680A (zh) * 2007-11-16 2010-08-04 波苏蛋白试剂公司 稳定蛋白质的辅剂
US8420081B2 (en) 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
US8858927B2 (en) 2007-12-21 2014-10-14 Lyotropic Therapeutics, Inc. Method for protection of peptides or proteins against non-enzymatic deamidation
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
JP5599778B2 (ja) 2008-04-14 2014-10-01 デピュイ・シンセス・プロダクツ・エルエルシー 液体緩衝ｇｄｆ−５製剤
US20110112029A1 (en) * 2008-05-23 2011-05-12 Novo Nordisk Health Care Ag Low viscosity compositions comprising a pegylated gla-domain containing protein
CA2932207A1 (en) 2008-10-20 2010-12-09 Abbvie Inc. Isolation and purification of antibodies using protein a affinity chromatography
PL3064579T3 (pl) 2008-10-31 2021-07-05 Aerase, Inc. Kompozycje farmaceutyczne i zastosowania medyczne uzyskanych metodami inżynierii ludzkich arginaz
CA2742817A1 (en) 2008-11-20 2010-05-27 Biogen Idec Ma Inc. Arginine inactivation of viruses
PE20120359A1 (es) 2009-03-06 2012-04-13 Genentech Inc Formulacion con anticuerpo
CA2766039A1 (en) 2009-06-29 2011-01-20 The Board Of Regents Of The University Of Texas System Arginase formulations and methods
PT2477603E (pt) 2009-09-17 2016-06-16 Baxalta Inc Co-formulação estável de hialuronidase e imunoglobulina e métodos para a sua utilização
JP5859987B2 (ja) 2010-02-24 2016-02-16 アレコー リミテッド タンパク質製剤
SI3409289T1 (sl) 2010-02-26 2020-12-31 Novo Nordisk A/S Stabilni sestavki, ki vsebujejo protitelo
SG184355A1 (en) * 2010-03-01 2012-11-29 Progenics Pharm Inc Concentrated protein formulations and uses thereof
US20130171128A1 (en) 2010-03-02 2013-07-04 Amgen Inc. Reducing viscosity of pharmaceutical formulations
BR112012027828A2 (pt) * 2010-05-03 2016-08-09 Genentech Inc composição de matéria, artigo de fabricação e método de redução da viscosidade de uma formulação contendo proteína e de preparação de uma formulação aquosa contendo proteína
SMT202000095T1 (it) * 2010-05-14 2020-03-13 Amgen Inc Formulazioni di anticorpi anti-sclerostina ad alta concentrazione
KR101924653B1 (ko) 2010-06-24 2018-12-03 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
WO2012122535A2 (en) 2011-03-10 2012-09-13 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of peptide drugs
AU2012326170B2 (en) 2011-10-18 2016-12-22 Coherus Biosciences, Inc. Etanercept formulations stabilized with metal ions
AU2012328524B2 (en) 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
AU2012332767C1 (en) 2011-10-31 2017-02-02 Genentech, Inc. Antibody formulations
SI2849723T1 (sl) 2012-05-18 2018-09-28 Genentech, Inc. Formulacije z visoko koncentracijo monoklonskih protiteles
WO2013180650A1 (en) 2012-05-31 2013-12-05 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
CN104870019A (zh) 2012-11-27 2015-08-26 阿特根公司 用于稳定蛋白质和Fc结构域融合的融合蛋白的组合物
MX350569B (es) 2012-12-03 2017-09-11 Landsteiner Scient S A De C V Composicion farmaceutica estable para el tratamiento de osteoporosis.
EP2968189A4 (en) 2013-03-15 2016-11-16 Ansun Biopharma Inc METHOD FOR PRODUCING 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
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog 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
WO2017070501A1 (en) 2015-10-23 2017-04-27 Reform Biologics, Llc Excipient compounds for biopolymer formulations
WO2018013673A1 (en) 2016-07-13 2018-01-18 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
US10646569B2 (en) 2017-05-16 2020-05-12 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
JP7256816B2 (ja) 2018-03-07 2023-04-12 コメラ ライフ サイエンシズ，インコーポレイテッド タンパク質製剤用の賦形剤化合物
CA3120023A1 (en) 2018-11-29 2020-06-04 Reform Biologics, Llc Excipient compounds for protein processing
EP4065166A4 (en) 2019-11-26 2023-12-20 Comera Life Sciences, Inc. EXCIPIENT COMPOUNDS FOR BIOPOLYMER FORMULATIONS
US20250186600A1 (en) 2020-09-11 2025-06-12 Comera Life Sciences, Inc. Excipient compounds for protein formulations

Also Published As

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

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
KR20190117631A (ko) 단백질 가공 처리를 위한 부형제 화합물
US11357857B2 (en) Excipient compounds for protein processing
WO2020112855A1 (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