CN115109148A - 用于检测宿主细胞蛋白的组合物和方法 - Google Patents

用于检测宿主细胞蛋白的组合物和方法 Download PDF

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Publication number
CN115109148A
CN115109148A CN202210618930.8A CN202210618930A CN115109148A CN 115109148 A CN115109148 A CN 115109148A CN 202210618930 A CN202210618930 A CN 202210618930A CN 115109148 A CN115109148 A CN 115109148A
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hcp
antibody
cho
polypeptide
sample
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G.毛
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Lonza AG
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Lonza AG
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    • 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
    • G01N33/94—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
    • G—PHYSICS
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    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • C—CHEMISTRY; METALLURGY
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    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P17/06—Antipsoriatics
    • 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
    • A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • 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
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • 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
    • 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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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Urology & Nephrology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
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  • General Physics & Mathematics (AREA)
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  • Pulmonology (AREA)
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CN202210618930.8A 2016-04-14 2017-04-12 用于检测宿主细胞蛋白的组合物和方法 Pending CN115109148A (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201662322621P 2016-04-14 2016-04-14
US62/322,621 2016-04-14
CN201780034661.8A CN109564217A (zh) 2016-04-14 2017-04-12 用于检测宿主细胞蛋白的组合物和方法
PCT/EP2017/058775 WO2017178526A1 (en) 2016-04-14 2017-04-12 Compositions and methods for the detection of host cell proteins

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US (3) US11353468B2 (https=)
EP (2) EP3683579B1 (https=)
JP (1) JP7565147B2 (https=)
KR (1) KR102408260B1 (https=)
CN (2) CN115109148A (https=)
AU (1) AU2017251360A1 (https=)
BR (1) BR112018071107A2 (https=)
CA (1) CA3020808A1 (https=)
EA (1) EA201892325A1 (https=)
ES (1) ES2994760T3 (https=)
IL (2) IL290358B2 (https=)
MX (1) MX2018012550A (https=)
SG (1) SG11201808992UA (https=)
WO (1) WO2017178526A1 (https=)

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CA3020808A1 (en) 2016-04-14 2017-10-19 Lonza Ltd Compositions and methods for the detection of host cell proteins
US11268951B2 (en) * 2017-09-20 2022-03-08 Charles River Laboratories International, Inc. CHO host cell protein assay
CN109078628B (zh) * 2018-08-27 2021-06-11 西北大学 一种以苄胺为配基的高效疏水相互作用色谱介质、制备方法及其在蛋白质复性与纯化的应用
CN111665364B (zh) * 2019-03-08 2025-01-21 湖州申科生物技术股份有限公司 一种评估hcp检测用多克隆抗体覆盖率的方法
KR20220107586A (ko) 2021-01-25 2022-08-02 금오공과대학교 산학협력단 전기신호를 이용한 세포수 검출장치 및 이를 이용한 검출방법
CN114966038A (zh) * 2022-04-13 2022-08-30 翌圣生物科技(上海)股份有限公司 精确定量检测生物医药制品中残留sp2/0宿主细胞蛋白的方法及ELISA检测试剂盒
WO2024084264A1 (en) * 2022-10-17 2024-04-25 HAJIAN TEHRANI, Behrooz Immunoassay for detecting host cell proteins of high five cells
CN115894677A (zh) * 2022-12-01 2023-04-04 湖州申科生物技术股份有限公司 一种提高hcp检测抗体覆盖率的抗体组合及其应用
CN117192107A (zh) * 2023-09-11 2023-12-08 福建基诺厚普生物科技有限公司 一种工艺特异性宿主细胞蛋白残留的检测方法及试剂盒
US20250334572A1 (en) * 2024-04-26 2025-10-30 Waters Technologies Corporation Host cell protein detection using lateral flow devices
CN118465164B (zh) * 2024-05-10 2025-02-14 上海澳斯康生物制药有限公司 一种用于检测hcp抗体覆盖率的方法及其应用

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KR102408260B1 (ko) 2022-06-10
MX2018012550A (es) 2019-07-08
IL290358B1 (en) 2023-11-01
ES2994760T3 (en) 2025-01-30
JP7565147B2 (ja) 2024-10-10
SG11201808992UA (en) 2018-11-29
IL262297A (en) 2018-11-29
US20220268792A1 (en) 2022-08-25
US12203948B2 (en) 2025-01-21
CA3020808A1 (en) 2017-10-19
US20190128903A1 (en) 2019-05-02
BR112018071107A2 (pt) 2019-04-16
IL290358B2 (en) 2024-03-01
EP3683579C0 (en) 2024-10-23
EP3443348A1 (en) 2019-02-20
EP3683579B1 (en) 2024-10-23
US20220268791A1 (en) 2022-08-25
KR20180129927A (ko) 2018-12-05
AU2017251360A1 (en) 2018-11-01
EA201892325A1 (ru) 2019-04-30
US11353468B2 (en) 2022-06-07
WO2017178526A1 (en) 2017-10-19
CN109564217A (zh) 2019-04-02
EP3683579A1 (en) 2020-07-22
IL290358A (en) 2022-04-01
JP2019516964A (ja) 2019-06-20

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