UY37547A - Métodos mejorados para potenciar la productividad de anticuerpos en cultivos celulares de mamíferos y minimizar la agregación durante los procesos posteriores y de formulación y las formulaciones de anticuerpos estables que se obtienen a partir de estos - Google Patents
Métodos mejorados para potenciar la productividad de anticuerpos en cultivos celulares de mamíferos y minimizar la agregación durante los procesos posteriores y de formulación y las formulaciones de anticuerpos estables que se obtienen a partir de estosInfo
- Publication number
- UY37547A UY37547A UY0001037547A UY37547A UY37547A UY 37547 A UY37547 A UY 37547A UY 0001037547 A UY0001037547 A UY 0001037547A UY 37547 A UY37547 A UY 37547A UY 37547 A UY37547 A UY 37547A
- Authority
- UY
- Uruguay
- Prior art keywords
- antibodies
- mammals
- formulations
- productivity
- minimize
- Prior art date
Links
- 238000004220 aggregation Methods 0.000 title abstract 3
- 230000002776 aggregation Effects 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 title abstract 3
- 238000009472 formulation Methods 0.000 title abstract 2
- 238000000034 method Methods 0.000 title 2
- 241000124008 Mammalia Species 0.000 title 1
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 238000004113 cell culture Methods 0.000 abstract 1
- 239000012535 impurity Substances 0.000 abstract 1
- 239000012669 liquid formulation Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000000178 monomer Substances 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 238000000746 purification Methods 0.000 abstract 1
- 238000011084 recovery Methods 0.000 abstract 1
- 238000004448 titration Methods 0.000 abstract 1
Classifications
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- 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
- A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
- A61K39/39525—Purification
-
- 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
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- 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
- A61K47/02—Inorganic compounds
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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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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- A61P31/12—Antivirals
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- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- C—CHEMISTRY; METALLURGY
- 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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- C—CHEMISTRY; METALLURGY
- 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
- C07K16/1002—Coronaviridae
- C07K16/1003—Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2 or Covid-19]
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- C—CHEMISTRY; METALLURGY
- 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
- C07K16/1081—Togaviridae, e.g. flavivirus, rubella virus, hog cholera virus
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- 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
- C12N5/0634—Cells from the blood or the immune system
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- A—HUMAN NECESSITIES
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- 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
- C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
- C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
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- 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
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- 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
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- 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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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Virology (AREA)
- Immunology (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Genetics & Genomics (AREA)
- Epidemiology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Microbiology (AREA)
- Biomedical Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Mycology (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Biotechnology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Hematology (AREA)
- General Engineering & Computer Science (AREA)
- Cell Biology (AREA)
- Pulmonology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- AIDS & HIV (AREA)
- Tropical Medicine & Parasitology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
La invención describe una plataforma eficaz para la fabricación y formulación de anticuerpos que proporciona i) un proceso de cultivo celular con una estrategia de alimentación mejorada que tiene como resultado una titulación alta de anticuerpos de entre 2 gm/L a 5 gm/L; ii) un proceso de purificación mejorado que presenta una recuperación porcentual óptima, un contenido de monómeros de gran pureza, mínima agregación / formación de partículas; niveles mínimos de impurezas; y iii) una formulación líquida estable de alta concentración con osmolalidad óptima y viscosidad baja en distintas variaciones de temperatura y desprovista de agregación.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN201621044139 | 2016-12-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| UY37547A true UY37547A (es) | 2018-06-29 |
Family
ID=61054429
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| UY0001037547A UY37547A (es) | 2016-12-23 | 2017-12-22 | Métodos mejorados para potenciar la productividad de anticuerpos en cultivos celulares de mamíferos y minimizar la agregación durante los procesos posteriores y de formulación y las formulaciones de anticuerpos estables que se obtienen a partir de estos |
Country Status (28)
| Country | Link |
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| 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) | TWI830692B (es) |
| UA (1) | UA128200C2 (es) |
| UY (1) | UY37547A (es) |
| WO (1) | WO2018116198A1 (es) |
| ZA (1) | ZA201904046B (es) |
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| US10227408B2 (en) | 2015-02-19 | 2019-03-12 | Compugen Ltd. | Anti-PVRIG antibodies and methods of use |
| MA50908A (fr) | 2017-11-17 | 2020-09-23 | Amgen Inc | Formulations de protéines de fusion vegfr-fc |
| BR112020022610A2 (pt) | 2018-05-10 | 2021-02-09 | Regeneron Pharmaceuticals, Inc. | proteína de fusão de receptor de vegf de alta concentração que contém formulações |
| CN110317267B (zh) * | 2018-08-09 | 2020-11-20 | 北京智仁美博生物科技有限公司 | 针对狂犬病病毒的双特异性抗体及其用途 |
| KR102270048B1 (ko) * | 2020-07-10 | 2021-06-28 | 주식회사 녹십자 | 바리셀라 조스터 바이러스 표면 단백질 항원의 생산 방법 |
| WO2020071876A1 (ko) * | 2018-10-04 | 2020-04-09 | 삼성바이오에피스 주식회사 | 점도가 감소된 고농도 트라스투주맙 또는 이의 항원 결합 단편 안정화 제제 |
| WO2020081408A1 (en) * | 2018-10-18 | 2020-04-23 | Merck Sharp & Dohme Corp. | Formulations of anti-rsv antibodies and methods of use thereof |
| WO2020088180A1 (en) * | 2018-11-02 | 2020-05-07 | Wuxi Biologics (Shanghai) Co., Ltd. | Cell culture process by intensified perfusion with continuous harvest and without cell bleeding |
| KR20210089215A (ko) | 2018-11-07 | 2021-07-15 | 머크 샤프 앤드 돔 코포레이션 | 항-lag3 항체 및 항-pd-1 항체의 공동-제제 |
| CN109576212B (zh) * | 2018-12-14 | 2021-06-22 | 杭州奕安济世生物药业有限公司 | 高密度接种培养中种子细胞的培养方法及其应用 |
| CN111349142B (zh) * | 2018-12-20 | 2024-09-13 | 上海百迈博制药有限公司 | 一种蛋白质的纯化方法 |
| EP3917951A1 (en) * | 2019-01-30 | 2021-12-08 | Amgen, Inc | Aflibercept attributes and methods of characterizing and modifying thereof |
| KR102735988B1 (ko) | 2019-02-18 | 2024-12-03 | 일라이 릴리 앤드 캄파니 | 치료 항체 제제 |
| CN112011514B (zh) * | 2019-05-31 | 2024-12-24 | 百济神州(苏州)生物科技有限公司 | 提高抗体adcc活性的细胞培养工艺 |
| KR102286892B1 (ko) * | 2019-07-08 | 2021-08-06 | 삼천당제약주식회사 | 안과용 단백질 제제의 정제방법 |
| BR112022001575A2 (pt) * | 2019-07-29 | 2022-04-19 | Compugen Ltd | Formulações de anticorpos anti-pvrig e usos dos mesmos |
| AU2020320222A1 (en) * | 2019-08-01 | 2022-03-03 | Gennova Biopharmaceuticals Limited | Opthalmic composition of Bevacizumab |
| BR112022005410A2 (pt) * | 2019-09-23 | 2022-06-21 | Merck Sharp & Dohme | Métodos e composições compreendendo um anticorpo monoclonal anti-ctla4 com proteínas de célula hospedeira reduzidas e estabilidade de polissorbato 80 aumentada |
| US20220348608A1 (en) * | 2019-10-04 | 2022-11-03 | Merck Patent Gmbh | Purification of proteins and viral inactivation |
| CN114980922A (zh) * | 2019-11-04 | 2022-08-30 | 康姆普根有限公司 | 抗pvrig抗体制剂和抗pd-1抗体的组合疗法 |
| CN112876567A (zh) * | 2019-11-29 | 2021-06-01 | 广东菲鹏制药股份有限公司 | Fc融合蛋白及其纯化方法 |
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| WO2021164107A1 (zh) * | 2020-02-19 | 2021-08-26 | 中国科学技术大学 | Il-6受体抗体的新用途 |
| KR102370142B1 (ko) * | 2020-03-23 | 2022-03-04 | 프레스티지바이오로직스 주식회사 | 항체 의약품 제조를 위한 배양 및 정제 공정의 하이브리드 시스템 |
| CN113563469A (zh) * | 2020-04-28 | 2021-10-29 | 江苏中新医药有限公司 | 高回收率纯化阿达木单抗的方法 |
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