MX2020008095A - Sistemas y métodos para caracterizar variantes de tamaño y carga de impurezas de productos farmacológicos. - Google Patents

Sistemas y métodos para caracterizar variantes de tamaño y carga de impurezas de productos farmacológicos.

Info

Publication number
MX2020008095A
MX2020008095A MX2020008095A MX2020008095A MX2020008095A MX 2020008095 A MX2020008095 A MX 2020008095A MX 2020008095 A MX2020008095 A MX 2020008095A MX 2020008095 A MX2020008095 A MX 2020008095A MX 2020008095 A MX2020008095 A MX 2020008095A
Authority
MX
Mexico
Prior art keywords
drug product
charge variant
product impurities
characterizing size
variant drug
Prior art date
Application number
MX2020008095A
Other languages
English (en)
Inventor
Shunhai Wang
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of MX2020008095A publication Critical patent/MX2020008095A/es

Links

Classifications

    • 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
    • B01D15/34—Size selective separation, e.g. size exclusion chromatography, gel filtration, permeation
    • 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
    • B01D15/361—Ion-exchange
    • B01D15/362—Cation-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
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361—Ion-exchange
    • B01D15/363—Anion-exchange
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • 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
    • C12N5/10—Cells modified by introduction of foreign genetic material
    • C12N5/12—Fused cells, e.g. hybridomas
    • 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
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • 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
    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/8509—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells for producing genetically modified animals, e.g. transgenic
    • C12N2015/8518—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells for producing genetically modified animals, e.g. transgenic expressing industrially exogenous proteins, e.g. for pharmaceutical use, human insulin, blood factors, immunoglobulins, pseudoparticles

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • General Engineering & Computer Science (AREA)
  • Cell Biology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Plant Pathology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Se proporcionan sistemas y métodos para caracterizar variantes de carga y tamaño de impurezas de productos farmacológicos proteicos.
MX2020008095A 2018-01-31 2019-01-28 Sistemas y métodos para caracterizar variantes de tamaño y carga de impurezas de productos farmacológicos. MX2020008095A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862624366P 2018-01-31 2018-01-31
PCT/US2019/015359 WO2019152303A1 (en) 2018-01-31 2019-01-28 Systems and methods for characterizing drug product impurities

Publications (1)

Publication Number Publication Date
MX2020008095A true MX2020008095A (es) 2020-09-24

Family

ID=65529777

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2020008095A MX2020008095A (es) 2018-01-31 2019-01-28 Sistemas y métodos para caracterizar variantes de tamaño y carga de impurezas de productos farmacológicos.

Country Status (15)

Country Link
US (1) US20190234959A1 (es)
EP (1) EP3746471A1 (es)
JP (1) JP7349998B2 (es)
KR (1) KR20200115485A (es)
CN (1) CN111655722A (es)
AR (1) AR113731A1 (es)
AU (1) AU2019215363A1 (es)
BR (1) BR112020013336A2 (es)
CA (1) CA3085177A1 (es)
EA (1) EA202091689A1 (es)
IL (1) IL276110A (es)
MX (1) MX2020008095A (es)
SG (1) SG11202005235WA (es)
TW (2) TW201940507A (es)
WO (1) WO2019152303A1 (es)

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* Cited by examiner, † Cited by third party
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MX2021008822A (es) 2019-01-25 2021-09-08 Regeneron Pharma Cromatografia en linea y espectrometro de masas de ionizacion por electrospray.
EP4132656A1 (en) * 2020-04-09 2023-02-15 CytomX Therapeutics, Inc. Compositions containing activatable antibodies
WO2023043733A1 (en) * 2021-09-14 2023-03-23 Regeneron Pharmaceuticals, Inc. Nmass spectrometry-based strategy for characterizing high molecular weight species of a biologic

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DE60309238T2 (de) 2002-03-08 2007-06-06 Asml Netherlands B.V. Lithographische Maske, lithographischer Apparat und Verfahren zur Herstellung einer Vorrichtung
CA2652976C (en) 2006-06-02 2015-08-11 Regeneron Pharmaceuticals, Inc. High affinity antibodies to human il-6 receptor
NZ574623A (en) * 2006-08-28 2011-12-22 Ares Trading Sa Process for the purification of fc-fusion proteins
US7608693B2 (en) 2006-10-02 2009-10-27 Regeneron Pharmaceuticals, Inc. High affinity human antibodies to human IL-4 receptor
JP5361738B2 (ja) * 2007-01-22 2013-12-04 ジェネンテック， インコーポレイテッド 多価電解質沈殿物及びタンパク質の精製
US7879984B2 (en) 2007-07-31 2011-02-01 Regeneron Pharmaceuticals, Inc. Human antibodies to human CD20 and method of using thereof
US8309088B2 (en) 2007-08-10 2012-11-13 Regeneron Pharmaceuticals, Inc. Method of treating osteoarthritis with an antibody to NGF
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
EP3916011A1 (en) 2009-06-26 2021-12-01 Regeneron Pharmaceuticals, Inc. Readily isolated bispecific antibodies with native immunoglobulin format
JO3417B1 (ar) 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
WO2011133886A2 (en) * 2010-04-23 2011-10-27 Genentech, Inc. Production of heteromultimeric proteins
JO3340B1 (ar) 2010-05-26 2019-03-13 Regeneron Pharma مضادات حيوية لـعامل تمايز النمو 8 البشري
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Also Published As

Publication number Publication date
AR113731A1 (es) 2020-06-03
CN111655722A (zh) 2020-09-11
US20190234959A1 (en) 2019-08-01
TW201940507A (zh) 2019-10-16
EA202091689A1 (ru) 2020-10-22
TW202325725A (zh) 2023-07-01
KR20200115485A (ko) 2020-10-07
WO2019152303A8 (en) 2020-01-09
SG11202005235WA (en) 2020-07-29
IL276110A (en) 2020-08-31
BR112020013336A2 (pt) 2020-12-01
AU2019215363A1 (en) 2020-07-23
JP2021512074A (ja) 2021-05-13
WO2019152303A1 (en) 2019-08-08
CA3085177A1 (en) 2019-08-08
EP3746471A1 (en) 2020-12-09
JP7349998B2 (ja) 2023-09-25

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