CN106659785B - 包含gm-csf中和化合物的液体制剂 - Google Patents

包含gm-csf中和化合物的液体制剂 Download PDF

Info

Publication number
CN106659785B
CN106659785B CN201580037108.0A CN201580037108A CN106659785B CN 106659785 B CN106659785 B CN 106659785B CN 201580037108 A CN201580037108 A CN 201580037108A CN 106659785 B CN106659785 B CN 106659785B
Authority
CN
China
Prior art keywords
antibody
seq
csf
amino acid
acid sequence
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
CN201580037108.0A
Other languages
English (en)
Chinese (zh)
Other versions
CN106659785A (zh
Inventor
W·迪卢齐奥
P·阮
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.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda GmbH
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 Takeda GmbH filed Critical Takeda GmbH
Publication of CN106659785A publication Critical patent/CN106659785A/zh
Application granted granted Critical
Publication of CN106659785B publication Critical patent/CN106659785B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/243Colony Stimulating Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Peptides Or Proteins (AREA)
CN201580037108.0A 2014-05-07 2015-05-04 包含gm-csf中和化合物的液体制剂 Active CN106659785B (zh)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
EP14167405.1 2014-05-07
EP14167405 2014-05-07
US201461994319P 2014-05-16 2014-05-16
US61/994,319 2014-05-16
US201462043636P 2014-08-29 2014-08-29
US62/043,636 2014-08-29
PCT/EP2015/059709 WO2015169742A1 (en) 2014-05-07 2015-05-04 Liquid formulation comprising gm-csf neutralizing compound

Publications (2)

Publication Number Publication Date
CN106659785A CN106659785A (zh) 2017-05-10
CN106659785B true CN106659785B (zh) 2021-04-30

Family

ID=50721582

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201580037108.0A Active CN106659785B (zh) 2014-05-07 2015-05-04 包含gm-csf中和化合物的液体制剂

Country Status (15)

Country Link
US (1) US11173208B2 (enExample)
EP (1) EP3139960B1 (enExample)
JP (1) JP6769879B2 (enExample)
KR (1) KR102385802B1 (enExample)
CN (1) CN106659785B (enExample)
AR (1) AR100268A1 (enExample)
AU (1) AU2015257798C1 (enExample)
BR (1) BR112016025126B1 (enExample)
EA (1) EA201691883A1 (enExample)
ES (1) ES2974895T3 (enExample)
MX (1) MX387451B (enExample)
PH (1) PH12016502100A1 (enExample)
TW (1) TWI682788B (enExample)
WO (1) WO2015169742A1 (enExample)
ZA (1) ZA201607097B (enExample)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20190255A1 (ar) 2017-04-28 2019-10-27 Amgen Inc صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها
CN107167613B (zh) * 2017-06-22 2018-10-02 深圳清华大学研究院 用于等离子体金芯片的蛋白点样缓冲液
EP3860567A4 (en) * 2018-10-01 2022-07-06 Amgen Inc. METHOD OF REDUCING AGGREGATION OF BISPECIFIC ANTIBODIES
US11267858B2 (en) 2019-05-31 2022-03-08 Spectrum Pharmaceuticals, Inc. Methods of treatment using G-CSF protein complex
US11684655B2 (en) 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex
BR112022007776A2 (pt) * 2019-10-25 2022-07-05 Amgen Inc Composições e métodos para minimizar a perda de proteína em baixas concentrações de proteína
CN115697406A (zh) * 2020-05-29 2023-02-03 美国安进公司 抗体配制品及其用途
AU2021392308A1 (en) * 2020-12-04 2023-06-22 CSL Innovation Pty Ltd Methods for treating inflammatory skin conditions
AU2021408085A1 (en) * 2020-12-21 2023-06-22 CSL Innovation Pty Ltd Methods for treating or preventing acute respiratory distress syndrome
KR102375269B1 (ko) * 2021-01-27 2022-03-17 한미약품 주식회사 단백질 액상 제제 및 이의 제조방법
CN117615788A (zh) * 2021-05-12 2024-02-27 安奈普泰斯生物有限公司 抗体组合物
EP4626406A1 (en) * 2022-12-01 2025-10-08 I-Mab Biopharma (Hangzhou) Co., Ltd. Liquid pharmaceutical formulation of anti-gm-csf antibody and uses thereof
WO2025217676A1 (en) * 2024-04-15 2025-10-23 CSL Innovation Pty Ltd Protein formulations and uses thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1612689A (zh) * 2001-11-08 2005-05-04 蛋白质设计实验室股份有限公司 IgG抗体稳定的液态药物制剂
CN101184777A (zh) * 2005-04-18 2008-05-21 米克罗麦特股份公司 人粒细胞巨噬细胞集落刺激因子的抗体中和剂
EP1947178A1 (en) * 2005-10-26 2008-07-23 Evec Incorporated Human monoclonal antibody binding to human gm-csf and antigen-binding site thereof
CN101861336A (zh) * 2007-09-18 2010-10-13 安姆根有限公司 人gm-csf抗原结合蛋白质

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2916711A1 (de) 1979-04-25 1980-11-06 Behringwerke Ag Blutgerinnungsfaktoren und verfahren zu ihrer herstellung
US4783441A (en) 1979-04-30 1988-11-08 Hoechst Aktiengesellschaft Aqueous protein solutions stable to denaturation
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
DE3583880D1 (de) 1984-04-09 1991-10-02 Takeda Chemical Industries Ltd Stabile interleukin-2-zusammensetzung.
AU600575B2 (en) 1987-03-18 1990-08-16 Sb2, Inc. Altered antibodies
GB8903593D0 (en) 1989-02-16 1989-04-05 Pafra Ltd Storage of materials
US5747032A (en) 1990-08-10 1998-05-05 Amrad Corporation Limited Monoclonal antibody to human granulocyte macrophage colony stimulating factor
US5580856A (en) 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof
US6685940B2 (en) * 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
PT1516628E (pt) 1995-07-27 2013-09-24 Genentech Inc Formulação de proteína liofilizada isotónica estável
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
DK1071752T3 (da) 1998-04-21 2003-10-20 Micromet Ag CD19xCD3-specifikke polypeptider og anvendelsen deraf
PL215168B1 (pl) 2002-02-27 2013-10-31 Immunex Corp Formulacja polipeptydowa
US7511476B2 (en) * 2005-01-04 2009-03-31 Digisensors, Inc. Electromagnetic sensor systems and methods of use thereof
PT1888643E (pt) 2005-05-18 2015-01-14 Morphosys Ag Anticorpos anti-fec-gm e as respectivas utilizações
KR101486183B1 (ko) 2006-02-08 2015-01-28 모르포테크, 인크. 항원성 gm-csf 펩티드 및 gm-csf에 대한 항체
SI1999152T1 (sl) 2006-03-27 2013-02-28 Medimmune Limited Vezni äślen za gm-csf receptor
EP1970384A1 (en) * 2007-03-14 2008-09-17 Ganymed Pharmaceuticals AG Monoclonal antibodies for treatment of cancer
WO2009002521A2 (en) 2007-06-25 2008-12-31 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
PL2215119T3 (pl) 2007-11-13 2013-06-28 Evec Inc Przeciwciała monoklonalne, które wiążą się z hGM-CSF i kompozycje lecznicze je zawierające
WO2009134805A2 (en) 2008-04-28 2009-11-05 Kalobios Pharmaceuticals, Inc. Antibodies to granulocyte-macrophage colony-stimulating factor
EP2362767B1 (en) * 2008-10-29 2017-12-06 Ablynx N.V. Formulations of single domain antigen binding molecules
AU2010338305A1 (en) 2009-12-29 2012-05-24 F. Hoffmann-La Roche Ag Antibody formulation
HK1208231A1 (en) * 2012-09-20 2016-02-26 Morphosys Ag Treatment for rheumatoid arthritis
AR093297A1 (es) * 2012-10-31 2015-05-27 Amgen Res Munich Gmbh Formulacion liquida que comprende un compuesto neutralizante de gm-csf

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1612689A (zh) * 2001-11-08 2005-05-04 蛋白质设计实验室股份有限公司 IgG抗体稳定的液态药物制剂
CN101184777A (zh) * 2005-04-18 2008-05-21 米克罗麦特股份公司 人粒细胞巨噬细胞集落刺激因子的抗体中和剂
EP1947178A1 (en) * 2005-10-26 2008-07-23 Evec Incorporated Human monoclonal antibody binding to human gm-csf and antigen-binding site thereof
CN101861336A (zh) * 2007-09-18 2010-10-13 安姆根有限公司 人gm-csf抗原结合蛋白质

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Self-Buffering Antibody Formulations;GOKARN et al.;《JOURNAL OF PHARMACEUTICAL SCIENCES》;20080831;第97卷(第8期);第3051-3066页 *

Also Published As

Publication number Publication date
ES2974895T3 (es) 2024-07-02
AU2015257798C1 (en) 2020-10-22
CA2946230A1 (en) 2015-11-12
BR112016025126A8 (pt) 2022-08-09
US11173208B2 (en) 2021-11-16
TWI682788B (zh) 2020-01-21
MX2016014411A (es) 2017-04-06
EP3139960A1 (en) 2017-03-15
PH12016502100A1 (en) 2017-02-06
US20170252436A1 (en) 2017-09-07
BR112016025126A2 (pt) 2018-02-20
MX387451B (es) 2025-03-18
TW201622702A (zh) 2016-07-01
EA201691883A1 (ru) 2017-05-31
AU2015257798B2 (en) 2020-04-23
AR100268A1 (es) 2016-09-21
AU2015257798A1 (en) 2016-11-17
CN106659785A (zh) 2017-05-10
EP3139960B1 (en) 2024-01-17
JP6769879B2 (ja) 2020-10-14
KR102385802B1 (ko) 2022-04-13
BR112016025126B1 (pt) 2024-02-15
WO2015169742A1 (en) 2015-11-12
KR20160149210A (ko) 2016-12-27
JP2017514868A (ja) 2017-06-08
ZA201607097B (en) 2024-11-27

Similar Documents

Publication Publication Date Title
CN106659785B (zh) 包含gm-csf中和化合物的液体制剂
CN104768580B (zh) 包含gm-csf中和化合物的液体制剂
JP6339578B2 (ja) Gm−csf中和化合物を含む凍結乾燥製剤
CA2946230C (en) Liquid formulation comprising gm-csf neutralizing compound
HK40037400A (en) Liquid formulation comprising gm-csf neutralizing compound
HK1235316B (en) Liquid formulation comprising gm-csf neutralizing compound
HK1235316A1 (en) Liquid formulation comprising gm-csf neutralizing compound
EA040788B1 (ru) Жидкая композиция, содержащая соединение, нейтрализующее gm-csf
HK1214761B (en) Liquid formulation comprising gm-csf neutralizing compound

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant
TR01 Transfer of patent right
TR01 Transfer of patent right

Effective date of registration: 20220520

Address after: Osaka, Japan

Patentee after: TAKEDA PHARMACEUTICAL Co.,Ltd.

Address before: Konstanz

Patentee before: TAKEDA GmbH