CA3082832C - Formulation - Google Patents

Formulation Download PDF

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Publication number
CA3082832C
CA3082832C CA3082832A CA3082832A CA3082832C CA 3082832 C CA3082832 C CA 3082832C CA 3082832 A CA3082832 A CA 3082832A CA 3082832 A CA3082832 A CA 3082832A CA 3082832 C CA3082832 C CA 3082832C
Authority
CA
Canada
Prior art keywords
antibody
formulations
pharmaceutical composition
formulation
antigen
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.)
Active
Application number
CA3082832A
Other languages
English (en)
French (fr)
Other versions
CA3082832A1 (en
Inventor
Sandrine DURRAN
Andrew Jeffrey Yates
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.)
UCB Biopharma SRL
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 CA3082832A1 publication Critical patent/CA3082832A1/en
Application granted granted Critical
Publication of CA3082832C publication Critical patent/CA3082832C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • 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
    • A61K47/08—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
    • 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)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
CA3082832A 2017-11-23 2018-11-13 Formulation Active CA3082832C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1719447.3A GB201719447D0 (en) 2017-11-23 2017-11-23 Pharmaceutical composition
GB1719447.3 2017-11-23
PCT/EP2018/081129 WO2019101582A1 (en) 2017-11-23 2018-11-13 Formulation

Publications (2)

Publication Number Publication Date
CA3082832A1 CA3082832A1 (en) 2019-05-31
CA3082832C true CA3082832C (en) 2023-07-18

Family

ID=60950516

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3082832A Active CA3082832C (en) 2017-11-23 2018-11-13 Formulation

Country Status (19)

Country Link
US (2) US11857625B2 (https=)
EP (1) EP3713602A1 (https=)
JP (1) JP6955632B2 (https=)
KR (1) KR102767553B1 (https=)
CN (1) CN111511399A (https=)
AR (1) AR113534A1 (https=)
AU (1) AU2018371056B2 (https=)
BR (1) BR112020009866A2 (https=)
CA (1) CA3082832C (https=)
CL (1) CL2020001307A1 (https=)
CO (1) CO2020006120A2 (https=)
EA (1) EA202091295A1 (https=)
GB (1) GB201719447D0 (https=)
IL (1) IL274719B2 (https=)
MX (1) MX2020004747A (https=)
MY (1) MY194682A (https=)
RU (1) RU2020120547A (https=)
SG (1) SG11202004601YA (https=)
WO (1) WO2019101582A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
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 (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007019232A2 (en) 2005-08-03 2007-02-15 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
MX2012007676A (es) 2009-12-29 2012-08-03 Hoffmann La Roche Nueva formulacion de anticuerpo.
HRP20171939T1 (hr) 2010-01-15 2018-03-23 Kirin-Amgen, Inc. Formulacija protutijela i režimi terapije
US9956165B2 (en) 2010-03-01 2018-05-01 Cytodyn Inc. Concentrated protein formulations and uses thereof
SMT202000095T1 (it) * 2010-05-14 2020-03-13 Amgen Inc Formulazioni di anticorpi anti-sclerostina ad alta concentrazione
FR2962650B1 (fr) 2010-07-19 2013-04-05 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines concentrees
MX362591B (es) * 2010-11-05 2019-01-25 Novartis Ag Uso de antagonistas de il-17.
SG10201510762YA (en) * 2011-01-14 2016-01-28 Ucb Pharma Sa Antibody molecules which bind il-17a and il-17f
PE20150190A1 (es) * 2012-06-21 2015-02-13 Ucb Pharma Sa Formulacion farmaceutica
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
CA2995222C (en) 2015-08-19 2021-07-13 Medimmune, Llc Stable anti-ifnar1 formulation
MY206805A (en) 2015-10-27 2025-01-08 UCB Biopharma SRL Methods of treatment using anti-il-17a/f antibodies
GB201522391D0 (en) * 2015-12-18 2016-02-03 Ucb Biopharma Sprl Antibody molecules
US20190060241A1 (en) 2016-04-13 2019-02-28 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
KR102329490B1 (ko) 2016-09-14 2021-11-23 베이징 한미 파마슈티컬 컴퍼니 리미티드 Ｉｌ-１７ａ에 특이적으로 결합하는 항체 및 그의 기능성 단편

Also Published As

Publication number Publication date
BR112020009866A2 (pt) 2020-11-17
AU2018371056A1 (en) 2020-06-04
MY194682A (en) 2022-12-14
JP6955632B2 (ja) 2021-10-27
CA3082832A1 (en) 2019-05-31
JP2021504321A (ja) 2021-02-15
EA202091295A1 (ru) 2020-09-03
EP3713602A1 (en) 2020-09-30
AR113534A1 (es) 2020-05-13
AU2018371056B2 (en) 2024-06-20
CO2020006120A2 (es) 2020-05-29
IL274719A (en) 2020-07-30
WO2019101582A1 (en) 2019-05-31
RU2020120547A (ru) 2021-12-23
GB201719447D0 (en) 2018-01-10
US11857625B2 (en) 2024-01-02
KR20200090829A (ko) 2020-07-29
MX2020004747A (es) 2020-08-20
US20210106683A1 (en) 2021-04-15
KR102767553B1 (ko) 2025-02-12
RU2020120547A3 (https=) 2021-12-23
CL2020001307A1 (es) 2020-10-16
IL274719B1 (en) 2024-06-01
US20240123065A1 (en) 2024-04-18
SG11202004601YA (en) 2020-06-29
CN111511399A (zh) 2020-08-07
IL274719B2 (en) 2024-10-01

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