JP7286536B2 - 非イオン性サーファクタント及びポリペプチドを含む組成物中の非イオン性サーファクタントを定量するためのクロマトグラフィー法 - Google Patents

非イオン性サーファクタント及びポリペプチドを含む組成物中の非イオン性サーファクタントを定量するためのクロマトグラフィー法 Download PDF

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JP7286536B2
JP7286536B2 JP2019507829A JP2019507829A JP7286536B2 JP 7286536 B2 JP7286536 B2 JP 7286536B2 JP 2019507829 A JP2019507829 A JP 2019507829A JP 2019507829 A JP2019507829 A JP 2019507829A JP 7286536 B2 JP7286536 B2 JP 7286536B2
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composition
polypeptide
antibody
ratio
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マリー モンッティ，
リチャード エル． ベアーズリー，
マイケル エス． チン，
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Genentech Inc
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/96—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation using ion-exchange
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361—Ion-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3847—Multimodal interactions
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/26—Conditioning of the fluid carrier; Flow patterns
    • G01N30/28—Control of physical parameters of the fluid carrier
    • G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/26—Conditioning of the fluid carrier; Flow patterns
    • G01N30/28—Control of physical parameters of the fluid carrier
    • G01N30/36—Control of physical parameters of the fluid carrier in high pressure liquid systems
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • 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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  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
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  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
JP2019507829A 2016-08-15 2017-08-14 非イオン性サーファクタント及びポリペプチドを含む組成物中の非イオン性サーファクタントを定量するためのクロマトグラフィー法 Active JP7286536B2 (ja)

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US201662375373P 2016-08-15 2016-08-15
US62/375,373 2016-08-15
PCT/US2017/046725 WO2018035025A1 (en) 2016-08-15 2017-08-14 Chromatography method for quantifying a non-ionic surfactant in a composition comprising the non-ionic surfactant and a polypeptide

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JP2019530857A JP2019530857A (ja) 2019-10-24
JP2019530857A5 JP2019530857A5 (https=) 2020-09-24
JP7286536B2 true JP7286536B2 (ja) 2023-06-05

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TWI870390B (zh) * 2019-02-27 2025-01-21 法商賽諾菲公司 以具內標之lc-ms於樣品中進行聚山梨醇酯定量之方法
CN113424057B (zh) * 2019-04-19 2024-04-05 海正生物制药有限公司 组合物中泊洛沙姆188的检测方法
JP2022531317A (ja) 2019-05-03 2022-07-06 ジェネンテック， インコーポレイテッド 精製プラットフォームから得られた組成物中の酵素加水分解活性速度を低下させる方法
EP4090666A1 (en) 2020-01-15 2022-11-23 F. Hoffmann-La Roche AG Methods to decrease impurities from recombinant protein manufacturing processes
CA3198684A1 (en) 2020-10-30 2022-05-05 Genentech, Inc. Purification platforms for obtaining pharmaceutical compositions having a reduced hydrolytic enzyme activity rate
BR112023016996A2 (pt) 2021-02-24 2023-09-26 Hoffmann La Roche Métodos para purificar um polipeptídeo terapêutico e para produzir um polipeptídeo terapêutico e usos de uma solução ácida e de uma solução alcalina
KR102283871B1 (ko) * 2021-03-02 2021-08-02 한국원자력연구원 크로마토그래피를 이용한 무담체 홀뮴-166의 분리 방법, 분리 장치 및 이에 의하여 분리된 무담체 홀뮴-166
AU2022429920A1 (en) * 2021-12-31 2024-07-25 Kashiv Biosciences, Llc A process for separation and quantification of non-ionic surfactant
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AU2017312540A1 (en) 2019-02-28
HUE071741T2 (hu) 2025-09-28
CN115598231B (zh) 2025-11-18
EP3497440A1 (en) 2019-06-19
JP2019530857A (ja) 2019-10-24
HRP20250718T1 (hr) 2025-08-15
MX2024006922A (es) 2024-06-20
PL3497440T3 (pl) 2025-08-04
IL264582A (en) 2019-02-28
KR20190051977A (ko) 2019-05-15
EP3497440B1 (en) 2025-04-30
TWI775770B (zh) 2022-09-01
BR112019002979B1 (pt) 2023-10-03
AR109343A1 (es) 2018-11-21
MX2019001572A (es) 2019-08-29
IL264582B (en) 2022-04-01
KR102617148B1 (ko) 2023-12-26
AU2022291517B2 (en) 2024-12-12
SG11201901228QA (en) 2019-03-28
AU2017312540B2 (en) 2023-02-02
ES3034020T3 (en) 2025-08-12
US20190178859A1 (en) 2019-06-13
CN115598231A (zh) 2023-01-13
BR112019002979A2 (pt) 2019-07-09
AU2022291517A1 (en) 2023-02-02
EP3497440C0 (en) 2025-04-30
US11680931B2 (en) 2023-06-20
US11333644B2 (en) 2022-05-17
WO2018035025A1 (en) 2018-02-22
TW201809658A (zh) 2018-03-16
CN109716127A (zh) 2019-05-03
CN109716127B (zh) 2022-06-14
US20230077255A1 (en) 2023-03-09
CA3033737A1 (en) 2018-02-22

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