MA47601A - Faible viscosité, formulations d'évolocumab à haute concentration et leurs procédés de préparation - Google Patents

Faible viscosité, formulations d'évolocumab à haute concentration et leurs procédés de préparation

Info

Publication number
MA47601A
MA47601A MA047601A MA47601A MA47601A MA 47601 A MA47601 A MA 47601A MA 047601 A MA047601 A MA 047601A MA 47601 A MA47601 A MA 47601A MA 47601 A MA47601 A MA 47601A
Authority
MA
Morocco
Prior art keywords
high concentration
low viscosity
preparation procedures
evolocumab formulations
evolocumab
Prior art date
Application number
MA047601A
Other languages
English (en)
Inventor
Elaheh Binabaji
Chio Mui Chan
Huanchun Cui
Sekhar Kanapuram
Christopher James Sloey
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 MA47601A publication Critical patent/MA47601A/fr

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • 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
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/16—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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • 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
    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C07K2317/70—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
    • 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
    • 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)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Analytical Chemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Water Supply & Treatment (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
MA047601A 2017-02-22 2018-02-22 Faible viscosité, formulations d'évolocumab à haute concentration et leurs procédés de préparation MA47601A (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201762462266P 2017-02-22 2017-02-22

Publications (1)

Publication Number Publication Date
MA47601A true MA47601A (fr) 2020-01-01

Family

ID=61617101

Family Applications (1)

Application Number Title Priority Date Filing Date
MA047601A MA47601A (fr) 2017-02-22 2018-02-22 Faible viscosité, formulations d'évolocumab à haute concentration et leurs procédés de préparation

Country Status (18)

Country Link
US (2) US11464857B2 (fr)
EP (1) EP3585821A1 (fr)
JP (1) JP7377596B2 (fr)
KR (2) KR20240060732A (fr)
CN (1) CN110536906A (fr)
AR (2) AR110938A1 (fr)
AU (1) AU2018224095B2 (fr)
BR (1) BR112019017393A8 (fr)
CA (1) CA3053394A1 (fr)
CL (1) CL2019002362A1 (fr)
EA (1) EA201991951A1 (fr)
IL (1) IL268515B2 (fr)
MA (1) MA47601A (fr)
MX (1) MX2019009952A (fr)
SG (1) SG11201907505TA (fr)
TW (1) TWI833690B (fr)
UY (1) UY37611A (fr)
WO (1) WO2018156741A1 (fr)

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JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
MX388858B (es) 2014-10-23 2025-03-20 Amgen Inc Reducción de la viscosidad de formulaciones farmacéuticas
CN108239150A (zh) 2016-12-24 2018-07-03 信达生物制药(苏州)有限公司 抗pcsk9抗体及其用途
JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
CN112218877B (zh) 2018-08-27 2025-07-25 瑞泽恩制药公司 拉曼光谱在下游纯化中的应用
US20220226477A1 (en) * 2019-04-23 2022-07-21 Amgen Inc. The use of low molecular weight polyvinylpyrrolidone (pvp) to reduce viscosity of high concentration protein formulations
IL292518B2 (en) 2019-12-17 2026-01-01 Amgen Inc Assembly and method for visual inspection of a container
JP2023514721A (ja) * 2020-02-24 2023-04-07 メディミューン，エルエルシー 抗内皮リパーゼ抗体の製剤
CA3204307A1 (fr) * 2020-12-17 2022-06-23 Astrazeneca Ab Formulations d'anticorps anti-il5r
EP4319795A4 (fr) * 2021-04-09 2025-03-05 Avantor Performance Materials, LLC Excipients d'amélioration de la performance et méthodes de réduction de la viscosité et d'augmentation de la stabilité de formulations biologiques
WO2025265012A1 (fr) * 2024-06-21 2025-12-26 Amgen Inc. Compositions comprenant des anticorps anti-pcsk9

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MX388858B (es) 2014-10-23 2025-03-20 Amgen Inc Reducción de la viscosidad de formulaciones farmacéuticas
MX388043B (es) 2014-12-03 2025-03-19 Csl Behring Ag Producto farmacéutico con estabilidad incrementada que comprende inmunoglobulinas.
CA3038909A1 (fr) 2016-09-29 2018-04-05 Amgen Inc. Proteines de liaison a l'antigene a viscosite faible et leurs procedes de preparation
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JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法

Also Published As

Publication number Publication date
SG11201907505TA (en) 2019-09-27
KR20190120257A (ko) 2019-10-23
EP3585821A1 (fr) 2020-01-01
AU2018224095B2 (en) 2025-02-27
MX2019009952A (es) 2019-10-14
IL268515A (en) 2019-09-26
BR112019017393A2 (pt) 2020-04-14
JP7377596B2 (ja) 2023-11-10
US20230226177A1 (en) 2023-07-20
CN110536906A (zh) 2019-12-03
US11464857B2 (en) 2022-10-11
BR112019017393A8 (pt) 2022-03-03
EA201991951A1 (ru) 2020-01-21
US20180237501A1 (en) 2018-08-23
WO2018156741A1 (fr) 2018-08-30
AR125766A2 (es) 2023-08-09
CA3053394A1 (fr) 2018-08-30
IL268515B2 (en) 2024-10-01
JP2018154616A (ja) 2018-10-04
IL268515B1 (en) 2024-06-01
AU2018224095A1 (en) 2019-08-22
KR20240060732A (ko) 2024-05-08
UY37611A (es) 2018-08-31
TWI833690B (zh) 2024-03-01
AR110938A1 (es) 2019-05-15
TW201841650A (zh) 2018-12-01
CL2019002362A1 (es) 2019-11-29
US12404344B2 (en) 2025-09-02

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