CN115151276A - 人抗tslp抗体的配制品及其使用方法 - Google Patents

人抗tslp抗体的配制品及其使用方法 Download PDF

Info

Publication number
CN115151276A
CN115151276A CN202180015035.0A CN202180015035A CN115151276A CN 115151276 A CN115151276 A CN 115151276A CN 202180015035 A CN202180015035 A CN 202180015035A CN 115151276 A CN115151276 A CN 115151276A
Authority
CN
China
Prior art keywords
composition
antibody
proline
amino acid
seq
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.)
Pending
Application number
CN202180015035.0A
Other languages
English (en)
Chinese (zh)
Inventor
L·罗森
J·利托夫斯基
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.)
Amgen Inc
Original Assignee
Amgen 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 Amgen Inc filed Critical Amgen Inc
Publication of CN115151276A publication Critical patent/CN115151276A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • C07K16/244Interleukins [IL]
    • C07K16/246IL-2
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • C07K16/244Interleukins [IL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN202180015035.0A 2020-02-18 2021-02-18 人抗tslp抗体的配制品及其使用方法 Pending CN115151276A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062978201P 2020-02-18 2020-02-18
US62/978,201 2020-02-18
PCT/US2021/018561 WO2021168100A1 (en) 2020-02-18 2021-02-18 Formulations of human anti-tslp antibodies and methods of using the same

Publications (1)

Publication Number Publication Date
CN115151276A true CN115151276A (zh) 2022-10-04

Family

ID=74860588

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180015035.0A Pending CN115151276A (zh) 2020-02-18 2021-02-18 人抗tslp抗体的配制品及其使用方法

Country Status (20)

Country Link
US (1) US20230081261A1 (https=)
EP (1) EP4106811A1 (https=)
JP (1) JP2023513833A (https=)
KR (1) KR20220143699A (https=)
CN (1) CN115151276A (https=)
AR (1) AR121368A1 (https=)
AU (1) AU2021221998A1 (https=)
BR (1) BR112022016456A2 (https=)
CA (1) CA3167975A1 (https=)
CL (1) CL2022002251A1 (https=)
CO (1) CO2022013251A2 (https=)
CR (1) CR20220465A (https=)
IL (1) IL295511A (https=)
JO (1) JOP20220193A1 (https=)
MX (1) MX2022010120A (https=)
PE (1) PE20230115A1 (https=)
PH (1) PH12022552132A1 (https=)
TW (1) TW202144004A (https=)
UY (1) UY39089A (https=)
WO (1) WO2021168100A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024146630A1 (zh) * 2023-01-06 2024-07-11 江苏恒瑞医药股份有限公司 一种tslp抗体治疗哮喘的方法

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4145105A1 (de) * 2021-09-06 2023-03-08 Anacyte Laboratories GmbH Lösung für die asservierung von zellen
WO2023040999A1 (zh) * 2021-09-18 2023-03-23 江苏康宁杰瑞生物制药有限公司 包含pd-l1抗原结合片段的组合物及其用途
CN116251181B (zh) * 2021-12-02 2023-09-22 北京东方百泰生物科技股份有限公司 一种抗tslp单克隆抗体的注射制剂
US12110324B2 (en) 2022-07-22 2024-10-08 Flagship Pioneering Innovations Vi, Llc Antigen binding molecules targeting thymic stromal lymphopoietin (TSLP)
TW202426485A (zh) * 2022-10-26 2024-07-01 美商安進公司 抗tslp抗體組成物及其用途
IL324470A (en) * 2023-05-18 2026-01-01 Medimmune Llc Treatment of corticosteroid-dependent asthma using anti-TSLP antibody

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170066823A1 (en) * 2015-09-09 2017-03-09 Matthew John EDWARDS Thymic stromal lymphopoietin (tslp)-binding molecules and methods of using the molecules
WO2018200533A1 (en) * 2017-04-28 2018-11-01 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
CN110573525A (zh) * 2017-04-12 2019-12-13 安进公司 用抗tslp抗体治疗哮喘

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
ATE158021T1 (de) 1990-08-29 1997-09-15 Genpharm Int Produktion und nützung nicht-menschliche transgentiere zur produktion heterologe antikörper
US7982016B2 (en) 2007-09-10 2011-07-19 Amgen Inc. Antigen binding proteins capable of binding thymic stromal lymphopoietin
US8359965B2 (en) 2007-09-17 2013-01-29 Oxford J Craig Apparatus and method for broad spectrum radiation attenuation
UY32038A (es) 2008-08-08 2010-03-26 Glaxo Wellcome Mfg Pte Ltd Inmunoblobulinas anti-cd127 y sus usos
ES2784123T3 (es) 2009-11-04 2020-09-22 Merck Sharp & Dohme Anticuerpo anti TSLP genomodificado
PH12012501364A1 (en) * 2010-01-15 2012-10-22 Amgen K A Inc Antibody formulation and therapeutic regimens
WO2012007495A1 (en) 2010-07-15 2012-01-19 F. Hoffmann-La Roche Ag Antibodies specifically binding to human tslpr and methods of use
AT510032B1 (de) 2010-11-30 2012-01-15 Steiner Erwin Ing Montageeinrichtung für fassadenelemente
US9100245B1 (en) 2012-02-08 2015-08-04 Amazon Technologies, Inc. Identifying protected media files
US9306926B2 (en) 2013-03-15 2016-04-05 Brian A. Truong User authentication using unique hidden identifiers
KR20170123315A (ko) 2015-03-11 2017-11-07 글락소스미스클라인 인털렉츄얼 프로퍼티 디벨로프먼트 리미티드 Tslp 결합 단백질
JP7200134B2 (ja) 2017-06-08 2023-01-06 アムジエン・インコーポレーテツド トルク駆動式薬物送達デバイス
MA50557A (fr) 2017-11-10 2020-09-16 Amgen Inc Pistons pour dispositifs d'administration de médicament
EP4321870B1 (en) 2018-03-13 2025-07-30 Amgen Inc. Methods for the preparation of trypsin-resistant polypeptides for mass spectrometric analysis
TW202541859A (zh) 2018-10-15 2025-11-01 美商安進公司 具有阻尼機構之藥物遞送裝置及自動注射器
WO2020081480A1 (en) 2018-10-15 2020-04-23 Amgen Inc. Platform assembly process for drug delivery device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170066823A1 (en) * 2015-09-09 2017-03-09 Matthew John EDWARDS Thymic stromal lymphopoietin (tslp)-binding molecules and methods of using the molecules
CN110573525A (zh) * 2017-04-12 2019-12-13 安进公司 用抗tslp抗体治疗哮喘
WO2018200533A1 (en) * 2017-04-28 2018-11-01 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
DHEERAJ S TOMAR等: "Molecular basis of high viscosity in concentrated antibody solutions: Strategies for high concentration drug product development", MABS, vol. 8, no. 2, 16 January 2016 (2016-01-16), pages 2 *
JESSICA J HUNG等: "Improving Viscosity and Stability of a Highly Concentrated Monoclonal Antibody Solution with Concentrated Proline", PHARM RES, vol. 35, no. 7, 30 April 2018 (2018-04-30), pages 133 *
ZHENHUAN ZHANG等: "Recent progresses of understanding the viscosity of concentrated protein solutions", CURRENT OPINION IN CHEMICAL ENGINEERING, vol. 16, 1 May 2017 (2017-05-01), pages 48 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024146630A1 (zh) * 2023-01-06 2024-07-11 江苏恒瑞医药股份有限公司 一种tslp抗体治疗哮喘的方法

Also Published As

Publication number Publication date
PE20230115A1 (es) 2023-01-27
UY39089A (es) 2021-08-31
TW202144004A (zh) 2021-12-01
US20230081261A1 (en) 2023-03-16
BR112022016456A2 (pt) 2022-10-04
CR20220465A (es) 2023-03-30
EP4106811A1 (en) 2022-12-28
MX2022010120A (es) 2022-09-05
WO2021168100A1 (en) 2021-08-26
JOP20220193A1 (ar) 2023-01-30
AU2021221998A1 (en) 2022-09-15
KR20220143699A (ko) 2022-10-25
IL295511A (en) 2022-10-01
AR121368A1 (es) 2022-06-01
JP2023513833A (ja) 2023-04-03
CO2022013251A2 (es) 2022-12-20
CA3167975A1 (en) 2021-08-26
PH12022552132A1 (en) 2024-01-29
CL2022002251A1 (es) 2023-04-14

Similar Documents

Publication Publication Date Title
CN115151276A (zh) 人抗tslp抗体的配制品及其使用方法
TWI856945B (zh) 用抗tslp抗體治療氣喘
EP3703818B1 (en) Il-4r antagonist for use in a method for treating or preventing asthma
EP3658184B1 (en) High concentration anti-c5 antibody formulations
EP2624865B1 (en) Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies
KR102122708B1 (ko) Il-4r 길항제 투여로 아토피성 피부염을 치료하는 방법
RU2665810C2 (ru) Содержащие антитела составы
RU2713406C2 (ru) Способы лечения или предупреждения астмы посредством введения антагониста il-4r
CN107257692A (zh) Il‑17抗体的药物产品和稳定液体组合物
KR20230175245A (ko) 변형된 항-tslp 항체
CN113474360A (zh) 治疗性抗体制剂
CN115279404A (zh) 人抗tslp抗体的配制品及治疗炎性疾病的方法
TW202200203A (zh) 包含抗IL-23p19抗體的製劑、其製備方法和用途
JP2021147383A (ja) アトピー性皮膚炎及び関連障害を処置するための方法
EA053285B1 (ru) Составы на основе антител к tslp человека и способы их применения
RU2847524C2 (ru) Высококонцентрированные составы антител к c5
WO2025221995A1 (en) Treatment of eosinophilic esophagitis with anti-tslp antibody
TW202140072A (zh) 人抗tslp 抗體的配製物及治療炎性疾病之方法
EA046767B1 (ru) Составы на основе антител к tslp человека и способы лечения воспалительного заболевания
KR20200069388A (ko) Il-4r 길항제 투여로 아토피성 피부염을 치료하는 방법
HK1258305A1 (en) Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies
HK1258305B (en) Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies
HK40025392B (en) High concentration anti-c5 antibody formulations
HK40025392A (en) High concentration anti-c5 antibody formulations
HK1188559A (en) Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies

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