TWI682788B - 包含gm-csf中和化合物之液態調配物 - Google Patents

包含gm-csf中和化合物之液態調配物 Download PDF

Info

Publication number
TWI682788B
TWI682788B TW104114614A TW104114614A TWI682788B TW I682788 B TWI682788 B TW I682788B TW 104114614 A TW104114614 A TW 104114614A TW 104114614 A TW104114614 A TW 104114614A TW I682788 B TWI682788 B TW I682788B
Authority
TW
Taiwan
Prior art keywords
antibody
seq
csf
amino acid
acid sequence
Prior art date
Application number
TW104114614A
Other languages
English (en)
Chinese (zh)
Other versions
TW201622702A (zh
Inventor
威洛R 迪魯茲歐
佛奧恩M 恩古揚
Original Assignee
德商武田公司
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 德商武田公司 filed Critical 德商武田公司
Publication of TW201622702A publication Critical patent/TW201622702A/zh
Application granted granted Critical
Publication of TWI682788B publication Critical patent/TWI682788B/zh

Links

Images

Classifications

    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • 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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22—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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/243—Colony Stimulating Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (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)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Biophysics (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)
TW104114614A 2014-05-07 2015-05-07 包含gm-csf中和化合物之液態調配物 TWI682788B (zh)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
EP14167405 2014-05-07
EP14167405.1 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

Publications (2)

Publication Number Publication Date
TW201622702A TW201622702A (zh) 2016-07-01
TWI682788B true TWI682788B (zh) 2020-01-21

Family

ID=50721582

Family Applications (1)

Application Number Title Priority Date Filing Date
TW104114614A TWI682788B (zh) 2014-05-07 2015-05-07 包含gm-csf中和化合物之液態調配物

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 (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL3615066T3 (pl) 2017-04-28 2024-04-29 Amgen Inc. Formulacje ludzkich przeciwciał anty-RANKL i sposoby ich zastosowania
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
WO2020072306A1 (en) * 2018-10-01 2020-04-09 Amgen Inc. Methods for 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
AU2020370372A1 (en) * 2019-10-25 2022-05-12 Amgen Inc. Compositions and methods for minimizing protein loss at low protein concentrations
CA3183934A1 (en) * 2020-05-29 2021-12-02 Amgen Inc. Antibody formulations and uses thereof
JP2023551549A (ja) * 2020-12-04 2023-12-08 シーエスエル イノベーション プロプライアタリー リミティド 炎症性皮膚状態を治療する方法
JP2024501659A (ja) * 2020-12-21 2024-01-15 シーエスエル イノベーション プロプライアタリー リミティド 急性呼吸窮迫症候群を治療又は防止するための方法
CN117062609A (zh) * 2020-12-21 2023-11-14 Csl创新私人有限公司 用于治疗或预防急性呼吸窘迫综合征的方法
KR102375269B1 (ko) * 2021-01-27 2022-03-17 한미약품 주식회사 단백질 액상 제제 및 이의 제조방법
EP4337257A1 (en) * 2021-05-12 2024-03-20 AnaptysBio, Inc. Antibody composition
CN119095584A (zh) * 2022-12-01 2024-12-06 天境生物科技(杭州)有限公司 抗gm-csf抗体的液体药物配制品及其用途
WO2025217676A1 (en) * 2024-04-15 2025-10-23 CSL Innovation Pty Ltd Protein formulations and uses thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1947178A1 (en) * 2005-10-26 2008-07-23 Evec Incorporated Human monoclonal antibody binding to human gm-csf and antigen-binding site thereof

Family Cites Families (28)

* 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
EP0158487B1 (en) 1984-04-09 1991-08-28 Takeda Chemical Industries, Ltd. Stable composition of interleukin-2
JP3101690B2 (ja) 1987-03-18 2000-10-23 エス・ビィ・2・インコーポレイテッド 変性抗体の、または変性抗体に関する改良
GB8903593D0 (en) 1989-02-16 1989-04-05 Pafra Ltd Storage of materials
WO1994009149A1 (en) 1990-08-10 1994-04-28 Amrad Corporation Limited Monoclonal antibody
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
CA2226575C (en) * 1995-07-27 2011-10-18 Genentech, Inc. Stabile isotonic lyophilized protein formulation
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
CA2326389C (en) 1998-04-21 2007-01-23 Micromet Gesellschaft Fur Biomedizinische Forschung Mbh Novel cd19xcd3 specific polypeptides and uses thereof
US20030138417A1 (en) * 2001-11-08 2003-07-24 Kaisheva Elizabet A. Stable liquid pharmaceutical formulation of IgG antibodies
CA2476934C (en) 2002-02-27 2009-06-16 Immunex Corporation Stabilized tnfr-fc composition comprising arginine
US7511476B2 (en) * 2005-01-04 2009-03-31 Digisensors, Inc. Electromagnetic sensor systems and methods of use thereof
MX2007012569A (es) * 2005-04-18 2007-12-06 Micromet Ag Neutralizadores de anticuerpos del factor estimulante de la colonia de macrofagos-granulocitos humanos.
ES2918209T3 (es) 2005-05-18 2022-07-14 Morphosys Ag Anticuerpos anti-GM-CSF y usos a partir de los mismos
KR101395515B1 (ko) 2006-02-08 2014-05-14 모르포테크, 인크. 항원성 gm-csf 펩티드 및 gm-csf에 대한 항체
KR101481844B1 (ko) 2006-03-27 2015-01-13 메디뮨 리미티드 Gm-csf 수용체에 대한 결합 성분
EP1970384A1 (en) * 2007-03-14 2008-09-17 Ganymed Pharmaceuticals AG Monoclonal antibodies for treatment of cancer
AU2008269086B2 (en) 2007-06-25 2014-06-12 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
TW200918553A (en) * 2007-09-18 2009-05-01 Amgen Inc Human GM-CSF antigen binding proteins
US8679502B2 (en) 2007-11-13 2014-03-25 Evec Inc. Monoclonal antibodies that bind to HGM-CSF and medical compositions comprising same
KR101824512B1 (ko) 2008-04-28 2018-02-02 휴머니건, 아이엔씨. 과립구-대식세포 콜로니 자극 인자에 대한 항체
RU2481824C2 (ru) * 2008-10-29 2013-05-20 Аблинкс Н.В Препараты однодоменных антигенсвязывающих молекул
US20110158987A1 (en) 2009-12-29 2011-06-30 F. Hoffmann-Laroche Ag Novel antibody formulation
CN104995210A (zh) * 2012-09-20 2015-10-21 莫弗系统股份公司 类风湿关节炎的治疗
AR093297A1 (es) * 2012-10-31 2015-05-27 Amgen Res Munich Gmbh Formulacion liquida que comprende un compuesto neutralizante de gm-csf

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1947178A1 (en) * 2005-10-26 2008-07-23 Evec Incorporated Human monoclonal antibody binding to human gm-csf and antigen-binding site thereof

Also Published As

Publication number Publication date
CN106659785A (zh) 2017-05-10
CA2946230A1 (en) 2015-11-12
BR112016025126A8 (pt) 2022-08-09
JP2017514868A (ja) 2017-06-08
TW201622702A (zh) 2016-07-01
MX2016014411A (es) 2017-04-06
EA201691883A1 (ru) 2017-05-31
WO2015169742A1 (en) 2015-11-12
AU2015257798A1 (en) 2016-11-17
CN106659785B (zh) 2021-04-30
AU2015257798B2 (en) 2020-04-23
PH12016502100A1 (en) 2017-02-06
MX387451B (es) 2025-03-18
EP3139960A1 (en) 2017-03-15
AR100268A1 (es) 2016-09-21
ZA201607097B (en) 2024-11-27
BR112016025126A2 (pt) 2018-02-20
BR112016025126B1 (pt) 2024-02-15
JP6769879B2 (ja) 2020-10-14
AU2015257798C1 (en) 2020-10-22
EP3139960B1 (en) 2024-01-17
US20170252436A1 (en) 2017-09-07
KR20160149210A (ko) 2016-12-27
US11173208B2 (en) 2021-11-16
ES2974895T3 (es) 2024-07-02
KR102385802B1 (ko) 2022-04-13

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
US9833410B2 (en) Lyophilized formulation comprising GM-CSF neutralizing compound
CA2671968A1 (en) Abeta antibody parenteral formulation
CA2946230C (en) Liquid formulation comprising gm-csf neutralizing compound
HK40037400A (en) Liquid formulation comprising gm-csf neutralizing compound
HK1235316A1 (en) Liquid formulation comprising gm-csf neutralizing compound
HK1235316B (en) Liquid formulation comprising gm-csf neutralizing compound
HK1214761B (en) Liquid formulation comprising gm-csf neutralizing compound
EA040788B1 (ru) Жидкая композиция, содержащая соединение, нейтрализующее gm-csf