BR112014021308B1 - Formulações farmacêuticas de anticorpos - Google Patents

Formulações farmacêuticas de anticorpos Download PDF

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Publication number
BR112014021308B1
BR112014021308B1 BR112014021308-9A BR112014021308A BR112014021308B1 BR 112014021308 B1 BR112014021308 B1 BR 112014021308B1 BR 112014021308 A BR112014021308 A BR 112014021308A BR 112014021308 B1 BR112014021308 B1 BR 112014021308B1
Authority
BR
Brazil
Prior art keywords
concentration
antibody
present
pharmaceutical formulation
formulation
Prior art date
Application number
BR112014021308-9A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112014021308A2 (pt
Inventor
Vincent John Corvari
Barbara Ann Williams
Patrick Daniel Donovan
Aaron Paul Markham
Original Assignee
Eli Lilly And Company
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 Eli Lilly And Company filed Critical Eli Lilly And Company
Publication of BR112014021308A2 publication Critical patent/BR112014021308A2/pt
Publication of BR112014021308B1 publication Critical patent/BR112014021308B1/pt

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Organic Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Rheumatology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (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)
BR112014021308-9A 2012-03-07 2013-03-01 Formulações farmacêuticas de anticorpos BR112014021308B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261607671P 2012-03-07 2012-03-07
US61/607,671 2012-03-07
PCT/US2013/028516 WO2013134052A1 (en) 2012-03-07 2013-03-01 Il-17 antibody formulation

Publications (2)

Publication Number Publication Date
BR112014021308A2 BR112014021308A2 (pt) 2017-07-04
BR112014021308B1 true BR112014021308B1 (pt) 2022-08-30

Family

ID=47892018

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014021308-9A BR112014021308B1 (pt) 2012-03-07 2013-03-01 Formulações farmacêuticas de anticorpos

Country Status (34)

Country Link
US (3) US9376491B2 (https=)
EP (2) EP2822590B1 (https=)
JP (1) JP6117252B2 (https=)
KR (1) KR101653082B1 (https=)
CN (1) CN104159612B (https=)
AU (1) AU2013230490B2 (https=)
BR (1) BR112014021308B1 (https=)
CA (1) CA2866128C (https=)
CL (1) CL2014002204A1 (https=)
CY (1) CY1118393T1 (https=)
DK (1) DK2822590T3 (https=)
EA (1) EA030742B1 (https=)
EC (1) ECSP14017562A (https=)
ES (1) ES2610707T3 (https=)
HR (1) HRP20161604T1 (https=)
HU (1) HUE031290T2 (https=)
IL (1) IL234053B (https=)
LT (1) LT2822590T (https=)
MA (1) MA37317B1 (https=)
ME (1) ME02565B (https=)
MX (1) MX362191B (https=)
MY (1) MY167233A (https=)
NZ (1) NZ627648A (https=)
PE (1) PE20142275A1 (https=)
PH (1) PH12014501985B1 (https=)
PL (1) PL2822590T3 (https=)
PT (1) PT2822590T (https=)
RS (1) RS55417B1 (https=)
SG (1) SG11201404491XA (https=)
SI (1) SI2822590T1 (https=)
TN (1) TN2014000341A1 (https=)
UA (1) UA114620C2 (https=)
WO (1) WO2013134052A1 (https=)
ZA (1) ZA201405654B (https=)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
US10646569B2 (en) 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
WO2019027828A1 (en) * 2017-08-04 2019-02-07 Eli Lilly And Company DOSAGE SCHEME OF ANTI-IL-17 ANTIBODIES
CN111032691A (zh) * 2017-08-23 2020-04-17 伊莱利利公司 生殖器银屑病的治疗
MX2017016884A (es) * 2017-12-19 2019-06-20 Probiomed S A De C V Formulacion farmaceutica estable de una proteina anti-tnfa.
KR20210096640A (ko) * 2018-11-29 2021-08-05 하버 바이오메드 테라푸틱스 리미티드 항-pd-l1 항체 제제
CN120241997A (zh) * 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
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
EP4268803A4 (en) * 2020-12-22 2025-04-16 Bio-Thera Solutions, Ltd. Stable antibody preparation, preparation method for same, and applications thereof
CN119147687B (zh) * 2024-11-11 2025-03-14 智翔(上海)医药科技有限公司 用于抗白介素17a抗体质量检测的方法

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1963368B3 (en) * 2005-12-13 2020-06-10 Eli Lilly And Company Anti-il-17 antibodies
JP5410985B2 (ja) * 2006-12-05 2014-02-05 クルセル ホランド ベー ヴェー 液体抗狂犬病抗体製剤
PH12012501364A1 (en) * 2010-01-15 2012-10-22 Amgen K A Inc Antibody formulation and therapeutic regimens

Also Published As

Publication number Publication date
JP6117252B2 (ja) 2017-04-19
EP2822590B1 (en) 2016-10-26
CN104159612A (zh) 2014-11-19
US20160280781A1 (en) 2016-09-29
JP2015510882A (ja) 2015-04-13
KR101653082B1 (ko) 2016-08-31
ES2610707T3 (es) 2017-05-03
CA2866128C (en) 2017-02-28
NZ627648A (en) 2016-10-28
CN104159612B (zh) 2016-03-16
IL234053B (en) 2018-06-28
PT2822590T (pt) 2016-12-15
BR112014021308A2 (pt) 2017-07-04
HRP20161604T1 (hr) 2016-12-30
HUE031290T2 (hu) 2017-06-28
US10472416B2 (en) 2019-11-12
US20150010573A1 (en) 2015-01-08
MA37317A1 (fr) 2016-03-31
ZA201405654B (en) 2016-05-25
CL2014002204A1 (es) 2015-01-30
WO2013134052A1 (en) 2013-09-12
MX2014010710A (es) 2015-04-14
SG11201404491XA (en) 2014-09-26
AU2013230490B2 (en) 2017-04-13
MX362191B (es) 2019-01-08
US9845353B2 (en) 2017-12-19
IL234053A0 (en) 2014-09-30
ECSP14017562A (es) 2015-09-30
RS55417B1 (sr) 2017-04-28
HK1199844A1 (en) 2015-07-24
PH12014501985A1 (en) 2014-11-24
SI2822590T1 (sl) 2017-01-31
UA114620C2 (uk) 2017-07-10
MY167233A (en) 2018-08-14
AU2013230490A1 (en) 2014-08-14
EP2822590A1 (en) 2015-01-14
LT2822590T (lt) 2017-01-25
DK2822590T3 (en) 2017-01-23
MA37317B1 (fr) 2016-10-31
US20180057584A1 (en) 2018-03-01
PL2822590T3 (pl) 2017-06-30
PH12014501985B1 (en) 2014-11-24
ME02565B (me) 2017-02-20
KR20140120938A (ko) 2014-10-14
EP3156073A1 (en) 2017-04-19
EA030742B1 (ru) 2018-09-28
US9376491B2 (en) 2016-06-28
TN2014000341A1 (en) 2015-12-21
CY1118393T1 (el) 2017-06-28
EA201491471A1 (ru) 2014-12-30
CA2866128A1 (en) 2013-09-12
PE20142275A1 (es) 2015-01-08

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 01/03/2013, OBSERVADAS AS CONDICOES LEGAIS