SA519402010B1 - طرق محسنة لتعزيز إنتاجية الأجسام المضادة في مزرعة خلايا الثدييات والحد من حدوت تكتل أثناء العمليات الفرعية والصياغة وصياغات من الأجسام المضادة مستقرة يتم الحصول عليها باستخدام هذه الطرق - Google Patents
طرق محسنة لتعزيز إنتاجية الأجسام المضادة في مزرعة خلايا الثدييات والحد من حدوت تكتل أثناء العمليات الفرعية والصياغة وصياغات من الأجسام المضادة مستقرة يتم الحصول عليها باستخدام هذه الطرقInfo
- Publication number
- SA519402010B1 SA519402010B1 SA519402010A SA519402010A SA519402010B1 SA 519402010 B1 SA519402010 B1 SA 519402010B1 SA 519402010 A SA519402010 A SA 519402010A SA 519402010 A SA519402010 A SA 519402010A SA 519402010 B1 SA519402010 B1 SA 519402010B1
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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
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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
- A61K39/39591—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
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- 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
- 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
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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
- A61K47/26—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
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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 [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
- C07K16/10—RNA viruses
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
- C07K16/10—RNA viruses
- C07K16/102—Coronaviridae (F)
- C07K16/104—Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2]
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
- C07K16/10—RNA viruses
- C07K16/116—Togaviridae (F); Matonaviridae (F); Flaviviridae (F)
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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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
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- 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)
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Abstract
يتعلق الاختراع الحالي بمنصة لتصنيع فعالة لتصنيع الجسم المضاد antibody والصياغة التي تُقدم 1) عملية استزراع الخلية cell culture process مع استراتيجية تغذية مُحسنة تتسبب في عيار مرتفع للجسم المضاد ما بين 2 جم/ لتر إلى 5 جم/ لتر؛ 2) عملية تنقية مُحسنة تُظهر نسبة الاستخلاص الأمثل، محتوى نقاء المونومير المرتفع، تكوين أقل تكتل/ جسيمات، أقل مستويات للشوائب؛ 3) سوائل مناسبة عالية التركيز تم صياغتها بأسمولالية Osmolality أمثل ولزوجة منخفضة عبر انحرافات درجة الحرارة المختلفة وخلوه من التكتل. تتضمن الأجسام المضادة antibodies المٌفضلة جسم مضاد antibody أحادي النسيلة IgG1 خاص بالقمة اللاصقة لفيروس حمى الضنك Dengue في نطاق III الخاص ببروتين E والجسم المضاد antibody أحادي النسيلة IgG1 الخاص بالجليكوبروتين G لسطح فيروس السعار rabies virus. الشكل 1.
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 |
|---|---|
| SA519402010B1 true SA519402010B1 (ar) | 2022-09-20 |
Family
ID=61054429
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SA519402010A SA519402010B1 (ar) | 2016-12-23 | 2019-06-20 | طرق محسنة لتعزيز إنتاجية الأجسام المضادة في مزرعة خلايا الثدييات والحد من حدوت تكتل أثناء العمليات الفرعية والصياغة وصياغات من الأجسام المضادة مستقرة يتم الحصول عليها باستخدام هذه الطرق |
Country Status (27)
| Country | Link |
|---|---|
| US (2) | US20200131251A1 (ar) |
| EP (1) | EP3559027B1 (ar) |
| JP (1) | JP7265477B6 (ar) |
| KR (1) | KR102595080B1 (ar) |
| CN (1) | CN110337445B (ar) |
| AR (1) | AR110584A1 (ar) |
| AU (1) | AU2017380842B2 (ar) |
| BR (1) | BR112019011900A2 (ar) |
| CO (1) | CO2019006289A2 (ar) |
| CR (1) | CR20190291A (ar) |
| DK (1) | DK3559027T3 (ar) |
| EA (1) | EA201900326A1 (ar) |
| ES (1) | ES2926028T3 (ar) |
| GE (2) | GEP20237513B (ar) |
| HR (1) | HRP20221071T1 (ar) |
| MX (1) | MX2019007564A (ar) |
| MY (1) | MY197200A (ar) |
| PE (1) | PE20191436A1 (ar) |
| PH (1) | PH12019501472A1 (ar) |
| PT (1) | PT3559027T (ar) |
| RS (1) | RS63533B1 (ar) |
| SA (1) | SA519402010B1 (ar) |
| TW (2) | TWI830692B (ar) |
| UA (1) | UA128200C2 (ar) |
| UY (1) | UY37547A (ar) |
| WO (1) | WO2018116198A1 (ar) |
| ZA (1) | ZA201904046B (ar) |
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| 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 |
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| MA54089A (fr) | 2018-10-31 | 2022-02-09 | Merck Sharp & Dohme | Anticorps anti-pd-1 humain et procédés d'utilisation associés |
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| MX2021008983A (es) * | 2019-01-30 | 2021-09-08 | Amgen Inc | Atributos de aflibercept y metodos de caracterizacion y modificacion de los mismos. |
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| US20220280643A1 (en) * | 2019-07-29 | 2022-09-08 | Mark White | Anti-pvrig antibodies formulations and uses thereof |
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| WO2021091605A1 (en) * | 2019-11-04 | 2021-05-14 | Compugen Ltd. | Combination therapy with anti-pvrig antibodies formulations and anti-pd-1 antibodies |
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