MX2020005247A - Metodos y formulaciones que permiten la modulacion de respuestas inmunitarias relacionadas con la administracion de un farmaco biofarmaceutico. - Google Patents

Metodos y formulaciones que permiten la modulacion de respuestas inmunitarias relacionadas con la administracion de un farmaco biofarmaceutico.

Info

Publication number
MX2020005247A
MX2020005247A MX2020005247A MX2020005247A MX2020005247A MX 2020005247 A MX2020005247 A MX 2020005247A MX 2020005247 A MX2020005247 A MX 2020005247A MX 2020005247 A MX2020005247 A MX 2020005247A MX 2020005247 A MX2020005247 A MX 2020005247A
Authority
MX
Mexico
Prior art keywords
methods
administration
immune responses
modulation
responses related
Prior art date
Application number
MX2020005247A
Other languages
English (en)
Inventor
Ulrich Kronthaler
Margot Viertlböck-Schudy
Melanie Baron
Original Assignee
Hexal 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48794008&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2020005247(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hexal Ag filed Critical Hexal Ag
Publication of MX2020005247A publication Critical patent/MX2020005247A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/39Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • 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
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • 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
    • C07K16/241Tumor Necrosis Factors
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invención se refiere a métodos de preparación ce una formulación farmacéutica que comprende un fármaco biofarmacéutico, dichos métodos permite la modulación de las respuestas inmunitarias relacionadas con la administración de la misma. La formulación comprende un regulacor de pH que comprende ácido hexanodioico o por lo menos una sal del mismo, y/o ácido cítrico o por lo menos una sal del mismo. La presente invención se refiere además a un método de uso de ácido hexanodioico o por lo menos una sal del mismo, y/o ácido cítrico o por lo menos una sal del mismo, para modular la inmunogenicidad de una formulación farmacéutica, a una formulación farmacéutica como tal, y a métodos de modulación o determinación de respuestas inmunitarias relacionadas con la administración de una formulación farmacéutica (Figura 4).
MX2020005247A 2013-07-19 2016-01-12 Metodos y formulaciones que permiten la modulacion de respuestas inmunitarias relacionadas con la administracion de un farmaco biofarmaceutico. MX2020005247A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP13177259 2013-07-19

Publications (1)

Publication Number Publication Date
MX2020005247A true MX2020005247A (es) 2020-08-24

Family

ID=48794008

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2016000405A MX380569B (es) 2013-07-19 2014-07-21 Métodos y formulaciones que permiten la modulación de respuestas inmunitarias relacionadas con la administración de un fármaco biofarmacéutico.
MX2020005247A MX2020005247A (es) 2013-07-19 2016-01-12 Metodos y formulaciones que permiten la modulacion de respuestas inmunitarias relacionadas con la administracion de un farmaco biofarmaceutico.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2016000405A MX380569B (es) 2013-07-19 2014-07-21 Métodos y formulaciones que permiten la modulación de respuestas inmunitarias relacionadas con la administración de un fármaco biofarmacéutico.

Country Status (12)

Country Link
US (1) US20160151484A1 (es)
EP (1) EP3021833B2 (es)
JP (2) JP2016525110A (es)
CN (1) CN105377237B (es)
AU (1) AU2014291970B2 (es)
BR (1) BR112016000563A2 (es)
CA (1) CA2914776C (es)
ES (1) ES2688726T5 (es)
MX (2) MX380569B (es)
RU (1) RU2662558C2 (es)
SI (1) SI3021833T2 (es)
WO (1) WO2015007912A1 (es)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9062106B2 (en) 2011-04-27 2015-06-23 Abbvie Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
WO2013158279A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Protein purification methods to reduce acidic species
WO2013158273A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Methods to modulate c-terminal lysine variant distribution
WO2013176754A1 (en) 2012-05-24 2013-11-28 Abbvie Inc. Novel purification of antibodies using hydrophobic interaction chromatography
US9512214B2 (en) 2012-09-02 2016-12-06 Abbvie, Inc. Methods to control protein heterogeneity
HK1207960A1 (en) 2013-03-12 2016-02-19 Abbvie Inc. Human antibodies that bind human tnf-alpha and methods of preparing the same
US9017687B1 (en) 2013-10-18 2015-04-28 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same using displacement chromatography
US9499614B2 (en) 2013-03-14 2016-11-22 Abbvie Inc. Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides
US9598667B2 (en) 2013-10-04 2017-03-21 Abbvie Inc. Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins
US9085618B2 (en) 2013-10-18 2015-07-21 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same
US9181337B2 (en) 2013-10-18 2015-11-10 Abbvie, Inc. Modulated lysine variant species compositions and methods for producing and using the same
US20150139988A1 (en) 2013-11-15 2015-05-21 Abbvie, Inc. Glycoengineered binding protein compositions

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
HUE026793T2 (en) * 2003-10-01 2016-07-28 Kyowa Hakko Kirin Co Ltd A method for stabilizing an antibody and a stabilized solution-type antibody preparation
GB0503337D0 (en) * 2005-02-17 2005-03-23 Glaxosmithkline Biolog Sa Compositions
RU2011126338A (ru) * 2008-11-28 2013-01-10 Эбботт Лэборетриз Стабильные композиции антител и способы их стабилизации
US20100278822A1 (en) * 2009-05-04 2010-11-04 Abbott Biotechnology, Ltd. Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
US8821865B2 (en) 2010-11-11 2014-09-02 Abbvie Biotechnology Ltd. High concentration anti-TNFα antibody liquid formulations
EP2471554A1 (en) * 2010-12-28 2012-07-04 Hexal AG Pharmaceutical formulation comprising a biopharmaceutical drug
GB201112429D0 (en) * 2011-07-19 2011-08-31 Glaxo Group Ltd Antigen-binding proteins with increased FcRn binding
RU2683020C2 (ru) * 2014-11-11 2019-03-26 Петр Иванович Никитин Субстанция и способ для модуляции активности агента в организме

Also Published As

Publication number Publication date
MX380569B (es) 2025-03-12
MX2016000405A (es) 2016-09-09
ES2688726T5 (es) 2022-06-27
CA2914776C (en) 2018-08-07
CA2914776A1 (en) 2015-01-22
EP3021833B1 (en) 2018-06-27
US20160151484A1 (en) 2016-06-02
JP6797767B2 (ja) 2020-12-09
AU2014291970B2 (en) 2017-09-28
CN105377237A (zh) 2016-03-02
BR112016000563A2 (pt) 2017-09-05
CN105377237B (zh) 2019-04-19
SI3021833T1 (sl) 2018-10-30
SI3021833T2 (sl) 2022-08-31
EP3021833B2 (en) 2022-03-30
EP3021833A1 (en) 2016-05-25
RU2662558C2 (ru) 2018-07-26
ES2688726T3 (es) 2018-11-06
JP2018012716A (ja) 2018-01-25
AU2014291970A1 (en) 2016-01-28
WO2015007912A1 (en) 2015-01-22
JP2016525110A (ja) 2016-08-22
RU2016105462A (ru) 2017-08-24

Similar Documents

Publication Publication Date Title
MX2020005247A (es) Metodos y formulaciones que permiten la modulacion de respuestas inmunitarias relacionadas con la administracion de un farmaco biofarmaceutico.
EA201890817A1 (ru) Кристаллические формы бета-никотинамида мононуклеотида
MX2022001755A (es) Compuestos de dinucleotidos ciclicos y metodos de uso.
BR112017004393A2 (pt) formulações de anticorpo
MX2017005575A (es) Formulacion farmaceutica de anticuerpos anti-tnf alfa.
EA201691978A1 (ru) Соединения в качестве модуляторов ror гамма
EP4285928A3 (en) Anti-pdl1 antibody formulations
MX363347B (es) Sal de omecamtiv mecarbilo y proceso para preparar la sal.
MX2016005395A (es) Formulacion estable de insulina glulisina.
AU2017242867A8 (en) Vortioxetine pamoic acid salt and crystal form thereof
CA3030422C (en) Stabilizing excipients for therapeutic protein formulations
EP4480544A3 (en) Immunomodulatory compositions andmethods of use thereof
EP4218823A3 (en) Novel polymeric hgh prodrugs
AU2014375637A1 (en) Formula of neuregulin preparation
WO2015020913A3 (en) Influenza hemagglutinin proteins and methods of thereof
BR112017014994A2 (pt) formulação em pó nasal para o tratamento de hipoglicemia
MX387731B (es) Composiciones farmacéuticas orales de mesalazina.
MX377919B (es) Composiciones farmaceuticas solidas que comprenden derivados de biopterina y usos de tales composiciones.
EA202090319A1 (ru) Пептидные конъюгаты, способ конъюгации и их использование
MX385925B (es) Oritavancina de alta pureza y método para producir la misma.
MX2022002635A (es) Anticuerpos anti proteina similar a angiopoyetina 4 y metodos de uso.
PH12015502556A1 (en) Modified release formulation
TW201613557A (en) Stable aqueous recombinant protein formulations
EA201691741A1 (ru) Фармацевтическая композиция
BR112018008769A2 (pt) formulações farmacêuticas, formulações líquidas aquosa reconstituída e liofilizada, seringa, método de fabricação de uma formulação farmacêutica, método para tratamento de uma doença e uso de uma formulação reconstruída