CL2020001307A1 - Formulación. - Google Patents

Formulación.

Info

Publication number
CL2020001307A1
CL2020001307A1 CL2020001307A CL2020001307A CL2020001307A1 CL 2020001307 A1 CL2020001307 A1 CL 2020001307A1 CL 2020001307 A CL2020001307 A CL 2020001307A CL 2020001307 A CL2020001307 A CL 2020001307A CL 2020001307 A1 CL2020001307 A1 CL 2020001307A1
Authority
CL
Chile
Prior art keywords
formulation
polysorbate
glycine
binds
antibody
Prior art date
Application number
CL2020001307A
Other languages
English (en)
Inventor
Sandrine Durran
Andrew Jeffrey Yates
Original Assignee
UCB Biopharma SRL
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 UCB Biopharma SRL filed Critical UCB Biopharma SRL
Publication of CL2020001307A1 publication Critical patent/CL2020001307A1/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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • C07K16/24—Immunoglobulins [IGs], 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • 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)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (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)

Abstract

La presente invención se refiere a composiciones farmacéuticas que comprenden desde un anticuerpo o un fragmento del mismo que se une a IL-17A e IL-17F y una combinación de glicina, tampón de acetato a un pH de 4,6 a 5,5 y polisorbato 80.
CL2020001307A 2017-11-23 2020-05-18 Formulación. CL2020001307A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GBGB1719447.3A GB201719447D0 (en) 2017-11-23 2017-11-23 Pharmaceutical composition

Publications (1)

Publication Number Publication Date
CL2020001307A1 true CL2020001307A1 (es) 2020-10-16

Family

ID=60950516

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2020001307A CL2020001307A1 (es) 2017-11-23 2020-05-18 Formulación.

Country Status (19)

Country Link
US (2) US11857625B2 (es)
EP (1) EP3713602A1 (es)
JP (1) JP6955632B2 (es)
KR (1) KR20200090829A (es)
CN (1) CN111511399A (es)
AR (1) AR113534A1 (es)
AU (1) AU2018371056A1 (es)
BR (1) BR112020009866A2 (es)
CA (1) CA3082832C (es)
CL (1) CL2020001307A1 (es)
CO (1) CO2020006120A2 (es)
EA (1) EA202091295A1 (es)
GB (1) GB201719447D0 (es)
IL (1) IL274719A (es)
MX (1) MX2020004747A (es)
MY (1) MY194682A (es)
RU (1) RU2020120547A (es)
SG (1) SG11202004601YA (es)
WO (1) WO2019101582A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
CN110585430B (zh) * 2019-09-29 2023-09-08 华博生物医药技术（上海）有限公司 一种人源化抗人il-17a单克隆抗体的药物组合物
CN112915201B (zh) * 2019-12-06 2023-06-27 珠海市丽珠单抗生物技术有限公司 包含抗il-17抗体的液体制剂
CN113769082A (zh) * 2020-06-10 2021-12-10 上海君实生物医药科技股份有限公司 抗il-17a抗体药物组合物及其用途

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ623901A (en) 2005-08-03 2015-10-30 Immunogen Inc Immunoconjugate formulations
GB0620729D0 (en) * 2006-10-18 2006-11-29 Ucb Sa Biological products
WO2009120684A1 (en) 2008-03-25 2009-10-01 Medimmune, Llc Antibody formulation
US20110158987A1 (en) 2009-12-29 2011-06-30 F. Hoffmann-Laroche Ag Novel antibody formulation
DK2523688T3 (en) 2010-01-15 2017-12-04 Kirin-Amgen Inc ANTIBODY FORMULATION AND THERAPEUTIC REGIMENS
WO2011109365A2 (en) 2010-03-01 2011-09-09 Progenics Pharmaceuticals, Inc. Concentrated protein formulations and uses thereof
EA027039B1 (ru) * 2010-05-14 2017-06-30 Эмджен Инк. Композиции с высокой концентрацией антител
FR2962650B1 (fr) 2010-07-19 2013-04-05 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines concentrees
EP3757126A1 (en) * 2010-11-05 2020-12-30 Novartis AG Methods of treating psoriatic arthritis using il-17 antagonists
BR112013017951B1 (pt) * 2011-01-14 2022-09-27 UCB Biopharma SRL Anticorpo de neutralização, sequência de dna isolada, vetor de clonagem ou expressão, processo para a produção do anticorpo, composição farmacêutica, uso de anticorpo e uso da composição farmacêutica
NZ702342A (en) * 2012-06-21 2016-07-29 Ucb Pharma Sa Pharmaceutical formulation
CN107148283A (zh) * 2014-10-31 2017-09-08 豪夫迈·罗氏有限公司 抗il‑17a和il‑17f交叉反应性抗体变体、包含其的组合物及其制备和使用方法
AR103173A1 (es) * 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
EP3769781B1 (en) 2015-08-19 2023-04-19 Astrazeneca AB Stable anti-ifnar1 formulation
CN108350068A (zh) * 2015-10-27 2018-07-31 Ucb生物制药私人有限公司 使用抗-il-17a/f抗体的治疗方法
EP3443346B1 (en) 2016-04-13 2023-08-30 Medimmune, LLC Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
ES2905917T3 (es) 2016-09-14 2022-04-12 Beijing Hanmi Pharmaceutical Co Ltd Anticuerpo que se une específicamente a IL-17A y fragmento funcional del mismo

Also Published As

Publication number Publication date
AU2018371056A1 (en) 2020-06-04
JP2021504321A (ja) 2021-02-15
KR20200090829A (ko) 2020-07-29
BR112020009866A2 (pt) 2020-11-17
CN111511399A (zh) 2020-08-07
EA202091295A1 (ru) 2020-09-03
CA3082832A1 (en) 2019-05-31
MY194682A (en) 2022-12-14
RU2020120547A3 (es) 2021-12-23
CA3082832C (en) 2023-07-18
CO2020006120A2 (es) 2020-05-29
AR113534A1 (es) 2020-05-13
US20210106683A1 (en) 2021-04-15
US20240123065A1 (en) 2024-04-18
RU2020120547A (ru) 2021-12-23
SG11202004601YA (en) 2020-06-29
JP6955632B2 (ja) 2021-10-27
IL274719A (en) 2020-07-30
US11857625B2 (en) 2024-01-02
EP3713602A1 (en) 2020-09-30
WO2019101582A1 (en) 2019-05-31
MX2020004747A (es) 2020-08-20
GB201719447D0 (en) 2018-01-10

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