EA202191931A1 - Способ характеризации видимых и/или невидимых частиц в биологических препаратах - Google Patents

Способ характеризации видимых и/или невидимых частиц в биологических препаратах

Info

Publication number
EA202191931A1
EA202191931A1 EA202191931A EA202191931A EA202191931A1 EA 202191931 A1 EA202191931 A1 EA 202191931A1 EA 202191931 A EA202191931 A EA 202191931A EA 202191931 A EA202191931 A EA 202191931A EA 202191931 A1 EA202191931 A1 EA 202191931A1
Authority
EA
Eurasian Patent Office
Prior art keywords
visible
characterizing
biological preparations
invisible
invisible particles
Prior art date
Application number
EA202191931A
Other languages
English (en)
Inventor
Сяобинь Сюй
Original Assignee
Ридженерон Фармасьютикалз, Инк.
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 Ридженерон Фармасьютикалз, Инк. filed Critical Ридженерон Фармасьютикалз, Инк.
Publication of EA202191931A1 publication Critical patent/EA202191931A1/ru

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6848—Methods of protein analysis involving mass spectrometry
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/65—Raman scattering
    • 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
    • G01N30/72—Mass spectrometers
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01J—ELECTRIC DISCHARGE TUBES OR DISCHARGE LAMPS
    • H01J49/00—Particle spectrometers or separator tubes
    • H01J49/0027—Methods for using particle spectrometers
    • H01J49/0031—Step by step routines describing the use of the apparatus
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01J—ELECTRIC DISCHARGE TUBES OR DISCHARGE LAMPS
    • H01J49/00—Particle spectrometers or separator tubes
    • H01J49/02—Details
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2560/00—Chemical aspects of mass spectrometric analysis of biological material

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Biophysics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

В данном изобретении предложен способ характеризации или количественного определения одного или более белков в видимых и/или невидимых частицах, образованных в образце, путем обнаружения по меньшей мере одной видимой или невидимой частицы в образце, выделения и захвата по меньшей мере одной видимой или невидимой частицы для определения присутствия белка и использование масс-спектрометра для характеризации белка.
EA202191931A 2019-01-30 2020-01-29 Способ характеризации видимых и/или невидимых частиц в биологических препаратах EA202191931A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962798750P 2019-01-30 2019-01-30
PCT/US2020/015699 WO2020160161A1 (en) 2019-01-30 2020-01-29 Method of characterization of visible and/or sub-visible particles in biologics

Publications (1)

Publication Number Publication Date
EA202191931A1 true EA202191931A1 (ru) 2022-02-14

Family

ID=69846159

Family Applications (1)

Application Number Title Priority Date Filing Date
EA202191931A EA202191931A1 (ru) 2019-01-30 2020-01-29 Способ характеризации видимых и/или невидимых частиц в биологических препаратах

Country Status (14)

Country Link
US (3) US11187707B2 (ru)
EP (1) EP3918340A1 (ru)
JP (1) JP7466553B2 (ru)
KR (1) KR20210121107A (ru)
CN (2) CN118330156A (ru)
AU (1) AU2020214797A1 (ru)
BR (1) BR112021013734A2 (ru)
CA (1) CA3126710A1 (ru)
EA (1) EA202191931A1 (ru)
IL (1) IL284885A (ru)
MX (1) MX2021009264A (ru)
SG (1) SG11202108031VA (ru)
WO (1) WO2020160161A1 (ru)
ZA (1) ZA202105176B (ru)

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CN118330156A (zh) * 2019-01-30 2024-07-12 瑞泽恩制药公司 表征生物制剂中的可见和/或亚可见粒子的方法
WO2022209422A1 (ja) * 2021-03-30 2022-10-06 富士フイルム株式会社 精製状態の推定方法
WO2024052440A1 (en) 2022-09-09 2024-03-14 F. Hoffmann-La Roche Ag Inspection system and method for a closed medical container
CN116563244B (zh) * 2023-05-11 2024-04-23 中国食品药品检定研究院 一种亚可见颗粒质控方法、***及设备

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US4734362A (en) * 1986-02-03 1988-03-29 Cambridge Bioscience Corporation Process for purifying recombinant proteins, and products thereof
AU736340B2 (en) * 1996-04-25 2001-07-26 Genicon Sciences Corporation Analyte assay using particulate labels
US6547828B2 (en) * 2001-02-23 2003-04-15 Smith & Nephew, Inc. Cross-linked ultra-high molecular weight polyethylene for medical implant use
US20050148098A1 (en) * 2003-12-30 2005-07-07 Xing Su Methods for using raman spectroscopy to obtain a protein profile of a biological sample
EP1899381A1 (en) * 2005-06-27 2008-03-19 Bionanophotonics A/S Immobilisation of polypeptides by irradiation
US20070134814A1 (en) * 2005-12-09 2007-06-14 Kajander E O Methods and compositions for the detection of calcifying nano-particles, identification and quantification of associated proteins thereon, and correlation to disease
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US20110059549A1 (en) * 2007-05-09 2011-03-10 Coleman Matthew A Methods and systems for producing nanolipoprotein particles
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EP4063854A1 (en) * 2012-01-11 2022-09-28 Takeda Pharmaceutical Company Limited Characterization of subvisible particles using a particle analyzer
EP2929050A1 (en) * 2012-12-10 2015-10-14 AdvanDx, Inc. Use of probes for mass spectrometric identification of microorganisms or cells and associated conditions of interest
TW201940691A (zh) * 2013-03-15 2019-10-16 美商艾爾德生物製藥股份有限公司 抗體純化及純度監測
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Also Published As

Publication number Publication date
US11187707B2 (en) 2021-11-30
MX2021009264A (es) 2021-08-24
KR20210121107A (ko) 2021-10-07
IL284885A (en) 2021-08-31
SG11202108031VA (en) 2021-08-30
CN113454460B (zh) 2024-06-11
JP2022519226A (ja) 2022-03-22
BR112021013734A2 (pt) 2021-09-21
US11693010B2 (en) 2023-07-04
CA3126710A1 (en) 2020-08-06
CN113454460A (zh) 2021-09-28
ZA202105176B (en) 2023-10-25
US20200241002A1 (en) 2020-07-30
AU2020214797A1 (en) 2021-08-12
CN118330156A (zh) 2024-07-12
WO2020160161A1 (en) 2020-08-06
JP7466553B2 (ja) 2024-04-12
EP3918340A1 (en) 2021-12-08
US20230273219A1 (en) 2023-08-31
US20220034905A1 (en) 2022-02-03

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