TW202123965A - 抗-il-23p19抗體調配物 - Google Patents

抗-il-23p19抗體調配物 Download PDF

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Publication number
TW202123965A
TW202123965A TW109130792A TW109130792A TW202123965A TW 202123965 A TW202123965 A TW 202123965A TW 109130792 A TW109130792 A TW 109130792A TW 109130792 A TW109130792 A TW 109130792A TW 202123965 A TW202123965 A TW 202123965A
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Taiwan
Prior art keywords
formulation
antibody
less
storage
buffer
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TW109130792A
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English (en)
Chinese (zh)
Inventor
派翠克 嘉理道爾
法登瑞齊特 托斯坦 史丘茲
Original Assignee
德商百靈佳殷格翰國際股份有限公司
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Publication of TW202123965A publication Critical patent/TW202123965A/zh

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    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/08Organic 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
    • A61K47/26Carbohydrates, 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
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • 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]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Rheumatology (AREA)
  • Endocrinology (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)
  • Peptides Or Proteins (AREA)
TW109130792A 2019-09-09 2020-09-08 抗-il-23p19抗體調配物 TW202123965A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962897930P 2019-09-09 2019-09-09
US62/897,930 2019-09-09

Publications (1)

Publication Number Publication Date
TW202123965A true TW202123965A (zh) 2021-07-01

Family

ID=72615913

Family Applications (2)

Application Number Title Priority Date Filing Date
TW113142787A TW202535466A (zh) 2019-09-09 2020-09-08 抗-il-23p19抗體調配物
TW109130792A TW202123965A (zh) 2019-09-09 2020-09-08 抗-il-23p19抗體調配物

Family Applications Before (1)

Application Number Title Priority Date Filing Date
TW113142787A TW202535466A (zh) 2019-09-09 2020-09-08 抗-il-23p19抗體調配物

Country Status (14)

Country Link
US (1) US20210070852A1 (enExample)
EP (1) EP4028419A1 (enExample)
JP (2) JP2022547162A (enExample)
KR (1) KR20220062359A (enExample)
CN (1) CN114340674A (enExample)
AU (1) AU2020345071A1 (enExample)
BR (1) BR112022003169A2 (enExample)
CA (1) CA3147328A1 (enExample)
CL (1) CL2024002086A1 (enExample)
IL (1) IL291131A (enExample)
MX (1) MX2022002850A (enExample)
PH (1) PH12022550558A1 (enExample)
TW (2) TW202535466A (enExample)
WO (1) WO2021048743A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023019556A1 (zh) * 2021-08-20 2023-02-23 齐鲁制药有限公司 一种高浓度抗her2的抗体制剂及其用途
TWI866551B (zh) * 2022-10-21 2024-12-11 韓商鐘根堂股份有限公司 穩定抗體組合物

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL307578A (en) 2015-02-04 2023-12-01 Boehringer Ingelheim Int Methods of treating inflammatory diseases
AU2020409124A1 (en) 2019-12-20 2022-06-30 Novarock Biotherapeutics, Ltd. Anti-interleukin-23 p19 antibodies and methods of use thereof
KR20250039516A (ko) * 2022-06-15 2025-03-20 애브비 인코포레이티드 리산키주맙 조성물
WO2025071362A1 (ko) * 2023-09-27 2025-04-03 삼성바이오에피스 주식회사 항-il-23 항체의 안정한 액상 제형
WO2025137347A1 (en) * 2023-12-20 2025-06-26 Abbvie Inc. High concentration risankizumab formulations

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU695129B2 (en) * 1995-02-06 1998-08-06 Genetics Institute, Llc Formulations for IL-12
EP1441589B1 (en) * 2001-11-08 2012-05-09 Abbott Biotherapeutics Corp. Stable liquid pharmaceutical formulation of igg antibodies
EP3501537A1 (en) * 2005-06-30 2019-06-26 Janssen Biotech, Inc. Anti-il23 antibodies, compositions, methods and uses
WO2010027766A1 (en) * 2008-08-27 2010-03-11 Schering Corporation Lyophilized formulatons of engineered anti-il-23p19 antibodies
US9265834B2 (en) * 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
PT2635601T (pt) * 2010-11-04 2016-09-27 Boehringer Ingelheim Int Anticorpos anti-il-23
EP4039275A1 (en) * 2012-05-03 2022-08-10 Boehringer Ingelheim International GmbH Anti-il-23p19 antibodies
UA117466C2 (uk) * 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
IL307578A (en) * 2015-02-04 2023-12-01 Boehringer Ingelheim Int Methods of treating inflammatory diseases
GB201612317D0 (en) * 2016-07-15 2016-08-31 Philogen Spa Antibody compositions
EP3677597A1 (en) * 2016-10-14 2020-07-08 Boehringer Ingelheim International GmbH Methods of treating diseases
EP3810268A1 (en) * 2018-06-20 2021-04-28 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an il-12/il-23 inhibitor

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023019556A1 (zh) * 2021-08-20 2023-02-23 齐鲁制药有限公司 一种高浓度抗her2的抗体制剂及其用途
TWI866551B (zh) * 2022-10-21 2024-12-11 韓商鐘根堂股份有限公司 穩定抗體組合物

Also Published As

Publication number Publication date
KR20220062359A (ko) 2022-05-16
JP2025163108A (ja) 2025-10-28
CA3147328A1 (en) 2021-03-18
BR112022003169A2 (pt) 2022-05-17
TW202535466A (zh) 2025-09-16
MX2022002850A (es) 2022-04-06
US20210070852A1 (en) 2021-03-11
JP2022547162A (ja) 2022-11-10
WO2021048743A1 (en) 2021-03-18
CN114340674A (zh) 2022-04-12
IL291131A (en) 2022-05-01
EP4028419A1 (en) 2022-07-20
CL2024002086A1 (es) 2025-01-10
AU2020345071A1 (en) 2022-03-24
PH12022550558A1 (en) 2023-02-20

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