CA3020808A1 - Compositions and methods for the detection of host cell proteins - Google Patents

Compositions and methods for the detection of host cell proteins Download PDF

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Publication number
CA3020808A1
CA3020808A1 CA3020808A CA3020808A CA3020808A1 CA 3020808 A1 CA3020808 A1 CA 3020808A1 CA 3020808 A CA3020808 A CA 3020808A CA 3020808 A CA3020808 A CA 3020808A CA 3020808 A1 CA3020808 A1 CA 3020808A1
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Prior art keywords
antibody
hcp
cho
polypeptide
preparation
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Abandoned
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CA3020808A
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English (en)
French (fr)
Inventor
Guojie MAO
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Lonza AG
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Lonza AG
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Publication of CA3020808A1 publication Critical patent/CA3020808A1/en
Abandoned legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/577Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/94Chemical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/04Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854Immunoglobulins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Diabetes (AREA)
  • Oncology (AREA)
  • Obesity (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
CA3020808A 2016-04-14 2017-04-12 Compositions and methods for the detection of host cell proteins Abandoned CA3020808A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662322621P 2016-04-14 2016-04-14
US62/322,621 2016-04-14
PCT/EP2017/058775 WO2017178526A1 (en) 2016-04-14 2017-04-12 Compositions and methods for the detection of host cell proteins

Publications (1)

Publication Number Publication Date
CA3020808A1 true CA3020808A1 (en) 2017-10-19

Family

ID=58645011

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3020808A Abandoned CA3020808A1 (en) 2016-04-14 2017-04-12 Compositions and methods for the detection of host cell proteins

Country Status (14)

Country Link
US (3) US11353468B2 (enExample)
EP (2) EP3443348A1 (enExample)
JP (1) JP7565147B2 (enExample)
KR (1) KR102408260B1 (enExample)
CN (2) CN109564217A (enExample)
AU (1) AU2017251360A1 (enExample)
BR (1) BR112018071107A2 (enExample)
CA (1) CA3020808A1 (enExample)
EA (1) EA201892325A1 (enExample)
ES (1) ES2994760T3 (enExample)
IL (2) IL290358B2 (enExample)
MX (1) MX2018012550A (enExample)
SG (1) SG11201808992UA (enExample)
WO (1) WO2017178526A1 (enExample)

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CN109564217A (zh) 2016-04-14 2019-04-02 隆扎有限公司 用于检测宿主细胞蛋白的组合物和方法
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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KR102571391B1 (ko) * 2013-09-13 2023-08-29 제넨테크, 인크. 정제된 재조합 폴리펩티드를 포함하는 방법 및 조성물
CN103792366B (zh) * 2014-01-21 2015-09-23 内蒙古必威安泰生物科技有限公司 口蹄疫疫苗宿主细胞蛋白双抗夹心酶联免疫检测试剂盒及使用方法
CN105021824A (zh) * 2015-07-06 2015-11-04 上海优者生物科技有限公司 用于定量检测生物医药制品中残留cho宿主细胞蛋白的elisa试剂盒及其使用方法
CN109564217A (zh) 2016-04-14 2019-04-02 隆扎有限公司 用于检测宿主细胞蛋白的组合物和方法

Also Published As

Publication number Publication date
KR102408260B1 (ko) 2022-06-10
WO2017178526A1 (en) 2017-10-19
IL290358A (en) 2022-04-01
US11353468B2 (en) 2022-06-07
ES2994760T3 (en) 2025-01-30
IL290358B1 (en) 2023-11-01
EP3683579B1 (en) 2024-10-23
EP3683579C0 (en) 2024-10-23
CN115109148A (zh) 2022-09-27
AU2017251360A1 (en) 2018-11-01
EP3443348A1 (en) 2019-02-20
JP2019516964A (ja) 2019-06-20
US20220268791A1 (en) 2022-08-25
EA201892325A1 (ru) 2019-04-30
MX2018012550A (es) 2019-07-08
IL262297A (en) 2018-11-29
US20190128903A1 (en) 2019-05-02
SG11201808992UA (en) 2018-11-29
JP7565147B2 (ja) 2024-10-10
US12203948B2 (en) 2025-01-21
BR112018071107A2 (pt) 2019-04-16
KR20180129927A (ko) 2018-12-05
IL290358B2 (en) 2024-03-01
EP3683579A1 (en) 2020-07-22
US20220268792A1 (en) 2022-08-25
CN109564217A (zh) 2019-04-02

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FZDE Discontinued

Effective date: 20220301