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PE20191436A1 - Metodos mejorados para estimular la productividad de anticuerpos en el cultivo de celulas de mamiferos y reducir la agregacion durante los procesos de formulacion post-tratamiento (downstream) y formulaciones de anticuerpos estables obtenidas a partir de los mismos - Google Patents

Metodos mejorados para estimular la productividad de anticuerpos en el cultivo de celulas de mamiferos y reducir la agregacion durante los procesos de formulacion post-tratamiento (downstream) y formulaciones de anticuerpos estables obtenidas a partir de los mismos

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Publication number
PE20191436A1
PE20191436A1 PE2019001305A PE2019001305A PE20191436A1 PE 20191436 A1 PE20191436 A1 PE 20191436A1 PE 2019001305 A PE2019001305 A PE 2019001305A PE 2019001305 A PE2019001305 A PE 2019001305A PE 20191436 A1 PE20191436 A1 PE 20191436A1
Authority
PE
Peru
Prior art keywords
mammal
cell culture
downstream
improved methods
during post
Prior art date
Application number
PE2019001305A
Other languages
English (en)
Inventor
Dhere Rajeev Mhalasakant
Peddi Reddy Srinivas Reddy
Singh Digamber Chahar
Yeolekar Leena Ravindra
Chouhan Pankaj Singh
Avalaskar Nikhil Dattatray
Original Assignee
Serum Institute Of India Pvt Ltd
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 Serum Institute Of India Pvt Ltd filed Critical Serum Institute Of India Pvt Ltd
Publication of PE20191436A1 publication Critical patent/PE20191436A1/es

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    • 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
    • A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
    • A61K39/39525—Purification
    • A—HUMAN NECESSITIES
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    • 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
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • 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
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    • 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
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • 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
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
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    • C07—ORGANIC CHEMISTRY
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1002—Coronaviridae
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    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
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    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Abstract

La invencion describe una plataforma eficaz para la fabricacion y formulacion de anticuerpos que proporciona i) un proceso de cultivo celular con una estrategia de alimentacion mejorada que resulta en un alto titulo de anticuerpos entre 2 g/L y 5 g/L; ii) un proceso de purificacion mejorado que muestra una recuperacion porcentual optima, contenido de monomero de alta pureza, minima agregacion/formacion de particulas, niveles minimos de impureza; y iii) una formulacion liquida estable de alta concentracion con osmolalidad optima y baja viscosidad a traves de diferentes excursiones de temperatura y sin agregacion. Los anticuerpos preferidos incluyen el anticuerpo monoclonal lgG1 especifico para el epitope del virus Dengue en el dominio 111 de la proteina E y el anticuerpo monoclonal lgG1 especifico para la glicoproteina G de la superficie del virus de la rabia
PE2019001305A 2016-12-23 2017-12-20 Metodos mejorados para estimular la productividad de anticuerpos en el cultivo de celulas de mamiferos y reducir la agregacion durante los procesos de formulacion post-tratamiento (downstream) y formulaciones de anticuerpos estables obtenidas a partir de los mismos PE20191436A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201621044139 2016-12-23
PCT/IB2017/058194 WO2018116198A1 (en) 2016-12-23 2017-12-20 Improved methods for enhancing antibody productivity in mammalian cell culture and minimizing aggregation during downstream, formulation processes and stable antibody formulations obtained thereof

Publications (1)

Publication Number Publication Date
PE20191436A1 true PE20191436A1 (es) 2019-10-14

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PE2019001305A PE20191436A1 (es) 2016-12-23 2017-12-20 Metodos mejorados para estimular la productividad de anticuerpos en el cultivo de celulas de mamiferos y reducir la agregacion durante los procesos de formulacion post-tratamiento (downstream) y formulaciones de anticuerpos estables obtenidas a partir de los mismos

Country Status (28)

Country Link
US (2) US20200131251A1 (es)
EP (1) EP3559027B1 (es)
JP (1) JP7265477B6 (es)
KR (1) KR102595080B1 (es)
CN (1) CN110337445B (es)
AR (1) AR110584A1 (es)
AU (1) AU2017380842B2 (es)
BR (1) BR112019011900A2 (es)
CA (1) CA3047530A1 (es)
CO (1) CO2019006289A2 (es)
CR (1) CR20190291A (es)
DK (1) DK3559027T3 (es)
EA (1) EA201900326A1 (es)
ES (1) ES2926028T3 (es)
GE (1) GEP20237513B (es)
HR (1) HRP20221071T1 (es)
MX (1) MX2019007564A (es)
MY (1) MY197200A (es)
PE (1) PE20191436A1 (es)
PH (1) PH12019501472A1 (es)
PT (1) PT3559027T (es)
RS (1) RS63533B1 (es)
SA (1) SA519402010B1 (es)
TW (2) TW202413401A (es)
UA (1) UA128200C2 (es)
UY (1) UY37547A (es)
WO (1) WO2018116198A1 (es)
ZA (1) ZA201904046B (es)

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ZA201904046B (en) 2022-02-23
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