MX2021002935A - Formulacion de anticuerpos contra csf-1r. - Google Patents

Formulacion de anticuerpos contra csf-1r.

Info

Publication number
MX2021002935A
MX2021002935A MX2021002935A MX2021002935A MX2021002935A MX 2021002935 A MX2021002935 A MX 2021002935A MX 2021002935 A MX2021002935 A MX 2021002935A MX 2021002935 A MX2021002935 A MX 2021002935A MX 2021002935 A MX2021002935 A MX 2021002935A
Authority
MX
Mexico
Prior art keywords
csf
antibody formulation
stabilizer
surfactant
range
Prior art date
Application number
MX2021002935A
Other languages
English (en)
Inventor
Kewei Yang
Satya Krishna Kishore Ravuri
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of MX2021002935A publication Critical patent/MX2021002935A/es

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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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

Abstract

La presente invención se refiere a una formulación farmacéutica líquida estable que comprende 40 mg/mL a 200 mg/mL de un anticuerpo contra CSF-1R; 0.01% (p/v) a 0.1% (p/v) de tensioactivo;5 mM a 100 mM de un agente amortiguador; y 10 mM a 500 mM de al menos un estabilizante; a un pH en el rango de 4.5 a 7.0.
MX2021002935A 2018-09-13 2019-09-12 Formulacion de anticuerpos contra csf-1r. MX2021002935A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18194145 2018-09-13
PCT/EP2019/074303 WO2020053321A1 (en) 2018-09-13 2019-09-12 Csf-1r antibody formulation

Publications (1)

Publication Number Publication Date
MX2021002935A true MX2021002935A (es) 2021-06-15

Family

ID=63579121

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021002935A MX2021002935A (es) 2018-09-13 2019-09-12 Formulacion de anticuerpos contra csf-1r.

Country Status (10)

Country Link
US (1) US20210205453A1 (es)
EP (1) EP3849518A1 (es)
KR (1) KR20210062027A (es)
CN (1) CN112822999A (es)
AU (1) AU2019339740A1 (es)
BR (1) BR112021004649A2 (es)
CA (1) CA3111858A1 (es)
IL (1) IL281255A (es)
MX (1) MX2021002935A (es)
WO (1) WO2020053321A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR097584A1 (es) 2013-09-12 2016-03-23 Hoffmann La Roche Terapia de combinación de anticuerpos contra el csf-1r humano y anticuerpos contra el pd-l1 humano
WO2018036852A1 (en) 2016-08-25 2018-03-01 F. Hoffmann-La Roche Ag Intermittent dosing of an anti-csf-1r antibody in combination with macrophage activating agent
JP7304287B2 (ja) 2016-12-22 2023-07-06 エフ・ホフマン－ラ・ロシュ・アクチェンゲゼルシャフト 抗ｐｄ－ｌ１／ｐｄ１治療の不成功後の、抗ｐｄ－ｌ１抗体との組み合わせでの抗ｃｓｆ－１ｒ抗体を用いた腫瘍の治療
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
RU2751249C1 (ru) * 2020-10-28 2021-07-12 Закрытое Акционерное Общество "Биокад" Моноклональное антитело, которое специфически связывается с csf-1r
CN113368234B (zh) * 2021-06-22 2022-02-22 宝船生物医药科技(上海)有限公司 一种稳定的抗csf-1r单克隆抗体的液体制剂及应用
WO2023019262A1 (en) * 2021-08-12 2023-02-16 AmMax Bio, Inc. Targeted delivery of anti-csf1r antibodies

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2722300T3 (es) 2009-12-10 2019-08-09 Hoffmann La Roche Anticuerpos que se unen preferentemente al dominio extracelular 4 de CSF1R y su uso
AR090244A1 (es) * 2012-03-08 2014-10-29 Hoffmann La Roche Formulacion de anticuerpo anti-selectina p
CA2969341C (en) * 2014-12-22 2023-07-04 Five Prime Therapeutics, Inc. Anti-csf1r antibodies for treating pvns
MY183068A (en) * 2015-02-09 2021-02-10 Ucb Biopharma Sprl Pharmaceutical formulation comprising antibody

Also Published As

Publication number Publication date
CN112822999A (zh) 2021-05-18
KR20210062027A (ko) 2021-05-28
AU2019339740A1 (en) 2021-04-01
US20210205453A1 (en) 2021-07-08
BR112021004649A2 (pt) 2021-06-01
AU2019339740A8 (en) 2021-04-08
EP3849518A1 (en) 2021-07-21
JP2022500386A (ja) 2022-01-04
CA3111858A1 (en) 2020-03-19
WO2020053321A1 (en) 2020-03-19
IL281255A (en) 2021-04-29

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