MX2021007047A - Formulaciones de anticuerpos. - Google Patents

Formulaciones de anticuerpos.

Info

Publication number
MX2021007047A
MX2021007047A MX2021007047A MX2021007047A MX2021007047A MX 2021007047 A MX2021007047 A MX 2021007047A MX 2021007047 A MX2021007047 A MX 2021007047A MX 2021007047 A MX2021007047 A MX 2021007047A MX 2021007047 A MX2021007047 A MX 2021007047A
Authority
MX
Mexico
Prior art keywords
lyophilized
formulations
present disclosure
formulation
disclosure relates
Prior art date
Application number
MX2021007047A
Other languages
English (en)
Inventor
Bodo Brocks
Robert Kellerer
Original Assignee
Morphosys Ag
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 Morphosys Ag filed Critical Morphosys Ag
Publication of MX2021007047A publication Critical patent/MX2021007047A/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
    • A61K47/16—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
    • A61K47/22—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
    • A61K9/0012—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
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere

Abstract

La presente divulgación se refiere a formulaciones de una proteína de unión a antígeno farmacéuticamente activa, tal como un anticuerpo monoclonal. En particular, la presente divulgación se refiere a una formulación farmacéutica liofilizada estable de un anticuerpo anti-CD38, a una formulación líquida reconstituida de tal formulación liofilizada y a métodos para preparar y usar tales formulaciones liofilizadas y reconstituidas.
MX2021007047A 2018-12-14 2019-12-13 Formulaciones de anticuerpos. MX2021007047A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18212591 2018-12-14
PCT/EP2019/085049 WO2020120730A1 (en) 2018-12-14 2019-12-13 Antibody formulations

Publications (1)

Publication Number Publication Date
MX2021007047A true MX2021007047A (es) 2021-10-26

Family

ID=64665564

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021007047A MX2021007047A (es) 2018-12-14 2019-12-13 Formulaciones de anticuerpos.

Country Status (13)

Country Link
US (1) US20220110872A1 (es)
EP (1) EP3893841A1 (es)
JP (1) JP2022512294A (es)
KR (1) KR20210104736A (es)
CN (1) CN113194925A (es)
AU (1) AU2019395841A1 (es)
BR (1) BR112021011399A2 (es)
CA (1) CA3122902A1 (es)
IL (1) IL283886A (es)
MX (1) MX2021007047A (es)
SG (1) SG11202104012QA (es)
TW (1) TWI820270B (es)
WO (1) WO2020120730A1 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2020225202B2 (en) 2019-02-18 2023-10-26 Eli Lilly And Company Therapeutic antibody formulation
CN116643056A (zh) * 2022-02-15 2023-08-25 厦门万泰凯瑞生物技术有限公司 促甲状腺激素受体复合物、试剂盒、制备方法和用途

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5641870A (en) 1995-04-20 1997-06-24 Genentech, Inc. Low pH hydrophobic interaction chromatography for antibody purification
AU729035B2 (en) 1997-06-12 2001-01-25 Novartis Ag Artificial antibody polypeptides
AU770718B2 (en) 1998-06-05 2004-02-26 Mayo Foundation For Medical Education And Research Use of genetically engineered antibodies to CD38 to treat multiple myeloma
EP1174440A1 (en) 2000-07-19 2002-01-23 U-BISys B.V. A selectively-expressed epitope on the human CD38 molecule detected by a phage display library-derived human scFv antibody fragment
ES2541489T3 (es) 2004-02-06 2015-07-21 Morphosys Ag Anticuerpos humanos anti-CD38 y usos para ellos
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
ME03528B (me) 2005-03-23 2020-04-20 Genmab As Antitijela protiv cd38 za liječenje multiplog mijeloma
US20090123950A1 (en) 2005-05-24 2009-05-14 Morphosys Ag Generation And Profiling Of Fully Human Hucal Gold®-Derived Therapeutic Antibodies Specific For Human CD38
HUE035250T2 (hu) 2005-10-12 2018-05-02 Morphosys Ag Humán CD38-ra specifikus teljesen humán HuCAL GOLD-eredetû terápiás ellenanyagok létrehozása és profilozása
EP1914242A1 (en) 2006-10-19 2008-04-23 Sanofi-Aventis Novel anti-CD38 antibodies for the treatment of cancer
RS59769B1 (sr) 2010-06-09 2020-02-28 Genmab As Antitela protiv humanog cd38
JOP20210044A1 (ar) 2010-12-30 2017-06-16 Takeda Pharmaceuticals Co الأجسام المضادة لـ cd38
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
WO2013059885A2 (en) 2011-10-28 2013-05-02 Cephalon Australia Pty Ltd Polypeptide constructs and uses thereof
US9486547B2 (en) * 2012-11-05 2016-11-08 Morphosys Ag Radiolabelled antibody and uses thereof
CN110526971B (zh) 2013-04-29 2023-06-30 泰华制药澳大利亚公司 抗-CD38抗体和与致弱干扰素α-2B的融合体
KR20160077155A (ko) 2013-10-31 2016-07-01 사노피 인간 암을 치료하기 위한 특이적 항-ｃｄ38 항체
KR20230022270A (ko) 2014-03-28 2023-02-14 젠코어 인코포레이티드 Cd38 및 cd3에 결합하는 이중특이적 항체
JP2017536830A (ja) 2014-11-26 2017-12-14 ゼンコー・インコーポレイテッドＸｅｎｃｏｒ、 Ｉｎｃ． Ｃｄ３及びｃｄ３８に結合するヘテロ二量体抗体
US20170121417A1 (en) * 2015-11-03 2017-05-04 Janssen Biotech, Inc. Subcutaneous Formulations of Anti-CD38 Antibodies and Their Uses
MA53356B1 (fr) 2015-11-03 2022-05-31 Janssen Biotech Inc Formulations sous-cutanées d'anticorps anti-cd38 et leurs utilisations
CN108884162A (zh) 2015-11-10 2018-11-23 汉堡-埃普多夫大学医学中心 针对cd38的抗原结合多肽
CN110603052A (zh) 2017-05-02 2019-12-20 默沙东公司 单独的和与程序性死亡受体1(pd-1)抗体组合的抗tigit抗体的稳定制剂及其使用方法

Also Published As

Publication number Publication date
BR112021011399A2 (pt) 2021-09-14
US20220110872A1 (en) 2022-04-14
SG11202104012QA (en) 2021-05-28
AU2019395841A1 (en) 2021-05-20
KR20210104736A (ko) 2021-08-25
EP3893841A1 (en) 2021-10-20
TW202034901A (zh) 2020-10-01
WO2020120730A1 (en) 2020-06-18
CN113194925A (zh) 2021-07-30
CA3122902A1 (en) 2020-06-18
TWI820270B (zh) 2023-11-01
JP2022512294A (ja) 2022-02-03
IL283886A (en) 2021-07-29

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