JP7084308B2 - 抗体安定性を増大させるための緩衝液製剤 - Google Patents
抗体安定性を増大させるための緩衝液製剤 Download PDFInfo
- Publication number
- JP7084308B2 JP7084308B2 JP2018540113A JP2018540113A JP7084308B2 JP 7084308 B2 JP7084308 B2 JP 7084308B2 JP 2018540113 A JP2018540113 A JP 2018540113A JP 2018540113 A JP2018540113 A JP 2018540113A JP 7084308 B2 JP7084308 B2 JP 7084308B2
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- antibody
- buffer
- histidine
- acetate
- antibody preparation
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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
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/26—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- 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
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Microbiology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Mycology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662290654P | 2016-02-03 | 2016-02-03 | |
| US62/290,654 | 2016-02-03 | ||
| PCT/US2017/016040 WO2017136433A1 (en) | 2016-02-03 | 2017-02-01 | Buffer formulations for enhanced antibody stability |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019504086A JP2019504086A (ja) | 2019-02-14 |
| JP2019504086A5 JP2019504086A5 (enExample) | 2020-03-12 |
| JP7084308B2 true JP7084308B2 (ja) | 2022-06-14 |
Family
ID=58046768
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018540113A Active JP7084308B2 (ja) | 2016-02-03 | 2017-02-01 | 抗体安定性を増大させるための緩衝液製剤 |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US11285210B2 (enExample) |
| EP (1) | EP3411401A1 (enExample) |
| JP (1) | JP7084308B2 (enExample) |
| CN (1) | CN109563161A (enExample) |
| AU (1) | AU2017213775A1 (enExample) |
| CA (1) | CA3013336A1 (enExample) |
| MX (1) | MX2018009341A (enExample) |
| WO (1) | WO2017136433A1 (enExample) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2014337263B2 (en) | 2013-10-16 | 2019-12-12 | Outlook Therapeutics, Inc. | Buffer formulations for enhanced antibody stability |
| EP2946766B1 (en) * | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
| EP3247718B1 (en) | 2015-01-21 | 2021-09-01 | Outlook Therapeutics, Inc. | Modulation of charge variants in a monoclonal antibody composition |
| EP3411401A1 (en) | 2016-02-03 | 2018-12-12 | Oncobiologics, Inc. | Buffer formulations for enhanced antibody stability |
| KR20190024572A (ko) * | 2017-08-30 | 2019-03-08 | (주)셀트리온 | TNFα 관련 질환을 치료하기 위한 피하 투여 요법 |
| WO2019147824A1 (en) | 2018-01-26 | 2019-08-01 | Progenity, Inc. | Treatment of a disease of the gastrointestinal tract with a pde4 inhibitor |
| US12171764B2 (en) | 2018-06-20 | 2024-12-24 | Biora Therapeutics, Inc. | Treatment of a disease of the gastrointestinal tract with a JAK or other kinase inhibitor |
| EP3810085A1 (en) | 2018-06-20 | 2021-04-28 | Progenity, Inc. | Treatment of a disease of the gastrointestinal tract with an integrin inhibitor |
| WO2019246271A1 (en) | 2018-06-20 | 2019-12-26 | Progenity, Inc. | Treatment of a disease of the gastrointestinal tract with an il-12/il-23 inhibitor |
| US20230041197A1 (en) | 2018-06-20 | 2023-02-09 | Progenity, Inc. | Treatment of a disease of the gastrointestinal tract with an immunomodulator |
| US20230312700A1 (en) | 2018-06-20 | 2023-10-05 | Progenity, Inc. | Treatment of a disease of the gastrointestinal tract with a tnf inhibitor |
| US12227565B2 (en) | 2018-06-20 | 2025-02-18 | Biora Therapeutics, Inc. | Method of formulating a pharmaceutical composition comprising administering an immune modulator to the small intestine |
| AU2020207124A1 (en) * | 2019-01-11 | 2021-07-29 | Samsung Bioepis Co., Ltd. | Pharmaceutical composition comprising antibody, device comprising same, and use thereof |
| JP2022548950A (ja) * | 2019-09-19 | 2022-11-22 | イノベント バイオロジクス(スーチョウ)カンパニー,リミティド | 抗pcsk9抗体を利用したコレステロール関連疾患の予防または治療方法 |
| KR20230008775A (ko) | 2020-05-08 | 2023-01-16 | 젠맵 에이/에스 | Cd3 및 cd20에 대한 이중특이적 항체 |
| US20240052026A1 (en) * | 2020-12-22 | 2024-02-15 | Bio-Thera Solutions, Ltd. | Stable antibody formulation, preparation method therefor, and applications thereof |
| TW202304507A (zh) * | 2021-04-02 | 2023-02-01 | 美商再生元醫藥公司 | 含有抗muc16x抗cd3雙特異性抗體之穩定調配物 |
| GB202115127D0 (en) * | 2021-10-21 | 2021-12-08 | Ucb Biopharma Sprl | Formulations |
| GB202115121D0 (en) * | 2021-10-21 | 2021-12-08 | Ucb Biopharma Sprl | Formulations |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| JP2015527402A (ja) | 2012-09-07 | 2015-09-17 | コヒラス・バイオサイエンシズ・インコーポレイテッド | 安定水性アダリムマブ製剤 |
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