CA3228269A1 - Antibody formulations - Google Patents

Antibody formulations Download PDF

Info

Publication number
CA3228269A1
CA3228269A1 CA3228269A CA3228269A CA3228269A1 CA 3228269 A1 CA3228269 A1 CA 3228269A1 CA 3228269 A CA3228269 A CA 3228269A CA 3228269 A CA3228269 A CA 3228269A CA 3228269 A1 CA3228269 A1 CA 3228269A1
Authority
CA
Canada
Prior art keywords
liquid composition
antibody
seq
buffer
arginine
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
CA3228269A
Other languages
English (en)
French (fr)
Inventor
Nicole BALL
Christopher Sloey
Alexis Lueras
Rulin Qian
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 CA3228269A1 publication Critical patent/CA3228269A1/en
Pending legal-status Critical Current

Links

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)
CA3228269A 2021-08-12 2022-08-11 Antibody formulations Pending CA3228269A1 (en)

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 (1)

Publication Number Publication Date
CA3228269A1 true CA3228269A1 (en) 2023-02-16

Family

ID=83151728

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3228269A Pending CA3228269A1 (en) 2021-08-12 2022-08-11 Antibody formulations

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
US20240343795A1 (en) 2024-10-17
TW202319398A (zh) 2023-05-16
PE20240650A1 (es) 2024-04-04
JP2024532736A (ja) 2024-09-10
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

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