JP2024532736A - 抗体処方物 - Google Patents

抗体処方物 Download PDF

Info

Publication number
JP2024532736A
JP2024532736A JP2024507886A JP2024507886A JP2024532736A JP 2024532736 A JP2024532736 A JP 2024532736A JP 2024507886 A JP2024507886 A JP 2024507886A JP 2024507886 A JP2024507886 A JP 2024507886A JP 2024532736 A JP2024532736 A JP 2024532736A
Authority
JP
Japan
Prior art keywords
liquid composition
antibody
seq
less
buffer
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
JP2024507886A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024532736A5 (enExample
Inventor
ボール，ニコール
スローイー，クリストファー
ルエラス，アレクシス
チエン，ルゥリン
Original Assignee
アムジエン・インコーポレーテツド
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 アムジエン・インコーポレーテツド filed Critical アムジエン・インコーポレーテツド
Publication of JP2024532736A publication Critical patent/JP2024532736A/ja
Publication of JP2024532736A5 publication Critical patent/JP2024532736A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • 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
    • 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
    • C07K16/244—Interleukins [IL]
    • 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
    • A61K47/26—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
    • A61K9/08—Solutions
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, 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)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2024507886A 2021-08-12 2022-08-11 抗体処方物 Pending JP2024532736A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163232299P 2021-08-12 2021-08-12
US63/232,299 2021-08-12
US202263316604P 2022-03-04 2022-03-04
US63/316,604 2022-03-04
PCT/US2022/040056 WO2023018870A1 (en) 2021-08-12 2022-08-11 Antibody formulations

Publications (2)

Publication Number Publication Date
JP2024532736A true JP2024532736A (ja) 2024-09-10
JP2024532736A5 JP2024532736A5 (enExample) 2025-08-13

Family

ID=83151728

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024507886A Pending JP2024532736A (ja) 2021-08-12 2022-08-11 抗体処方物

Country Status (16)

Country Link
US (1) US20240343795A1 (enExample)
EP (1) EP4384217A1 (enExample)
JP (1) JP2024532736A (enExample)
KR (1) KR20240046881A (enExample)
AU (1) AU2022325870A1 (enExample)
CA (1) CA3228269A1 (enExample)
CL (1) CL2024000401A1 (enExample)
CO (1) CO2024001383A2 (enExample)
CR (1) CR20240130A (enExample)
IL (1) IL310275A (enExample)
JO (1) JOP20240024A1 (enExample)
MX (1) MX2024001934A (enExample)
PE (1) PE20240650A1 (enExample)
TW (1) TW202319398A (enExample)
UY (1) UY39896A (enExample)
WO (1) WO2023018870A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2026062214A1 (en) * 2024-09-19 2026-03-26 Sanofi Formulations comprising lunsekimig

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW201605896A (zh) 2013-08-30 2016-02-16 安美基股份有限公司 Gitr抗原結合蛋白
EP2963057A1 (en) 2014-07-02 2016-01-06 Calypso Biotech SA Antibodies to IL-15
EP3472202A1 (en) 2016-06-15 2019-04-24 Amgen Inc. Methods and compositions for the treatment of celiac disease, non-celiac gluten sensitivity, and refractory celiac disease
EP3824906A1 (en) * 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
PL3615066T3 (pl) 2017-04-28 2024-04-29 Amgen Inc. Formulacje ludzkich przeciwciał anty-RANKL i sposoby ich zastosowania
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
MX2020007291A (es) 2018-01-12 2020-09-10 Amgen Inc Anticuerpos anti-pd-1 y metodos de tratamiento.
WO2021079337A1 (en) * 2019-10-23 2021-04-29 Cadila Healthcare Limited Pharmaceutical formulation of anti-her2 antibody and preparation thereof

Also Published As

Publication number Publication date
IL310275A (en) 2024-03-01
WO2023018870A1 (en) 2023-02-16
MX2024001934A (es) 2024-03-04
JOP20240024A1 (ar) 2024-02-08
CA3228269A1 (en) 2023-02-16
US20240343795A1 (en) 2024-10-17
TW202319398A (zh) 2023-05-16
PE20240650A1 (es) 2024-04-04
KR20240046881A (ko) 2024-04-11
EP4384217A1 (en) 2024-06-19
CO2024001383A2 (es) 2024-03-07
CL2024000401A1 (es) 2024-06-21
AU2022325870A1 (en) 2024-02-08
CR20240130A (es) 2024-04-12
UY39896A (es) 2023-02-28

Similar Documents

Publication Publication Date Title
AU2020244614B2 (en) Stable protein solution formulation containing high concentration of an anti-VEGF antibody
AU2019232625B2 (en) Anti-PD-1 antibody compositions
EP3043776B1 (en) Liquid protein formulations containing water soluble organic dyes
CN104302320B (zh) 冻干以及水性抗cd40抗体制剂
TWI857996B (zh) 含高濃度抗ｖｅｇｆ抗體之蛋白質溶液配製物
US20180179290A1 (en) Antibody formulation
CN104220047B (zh) 含有生物治疗剂和胍或胍衍生物的水性药物组合物以及包含所述组合物的注射剂
MX2015002233A (es) Formulaciones de liposomas.
TW202345902A (zh) 含有ｐｄ－１抗體的穩定高濃度精胺酸配製物及其使用方法
TWI718890B (zh) 含有抗-介白素-4受體(il-4r)抗體之安定化配製物
US20240343795A1 (en) Antibody formulations
CN111683681B (zh) 包含抗ox40抗体的制剂、其制备方法及其用途
CN119255788A (zh) 降黏度赋形剂组合物和包含其的低黏度高浓缩蛋白质制剂
HK40110344A (en) Antibody formulations
CN117794574A (zh) 抗体配制品
CA3093036C (en) Anti-pd-1 antibody compositions
RU2772781C2 (ru) Композиции анти-pd-1 антител
CA2966758C (en) Stable protein solution formulation containing high concentration of an anti-vegf antibody
TW202541845A (zh) 穩定醫藥製劑
TW202342098A (zh) 含有ｐｄ－１抗體的穩定高濃度氯化鈉配製物及其使用方法
HK40131523A (en) Stable protein solution formulation containing high concentration of an anti-vegf antibody
HK40041199A (en) Anti-pd-1 antibody compositions

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250804

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20250804