JP7565147B2 - 宿主細胞タンパク質の検出のための組成物及び方法 - Google Patents
宿主細胞タンパク質の検出のための組成物及び方法 Download PDFInfo
- Publication number
- JP7565147B2 JP7565147B2 JP2018553973A JP2018553973A JP7565147B2 JP 7565147 B2 JP7565147 B2 JP 7565147B2 JP 2018553973 A JP2018553973 A JP 2018553973A JP 2018553973 A JP2018553973 A JP 2018553973A JP 7565147 B2 JP7565147 B2 JP 7565147B2
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- hcp
- antibody
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- recombinant polypeptide
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- 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
- G01N33/94—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
- 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
- G01N33/577—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- 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
- A61P3/00—Drugs for disorders of the metabolism
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Pharmacology & Pharmacy (AREA)
- Biochemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biomedical Technology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Urology & Nephrology (AREA)
- Physical Education & Sports Medicine (AREA)
- Rheumatology (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Food Science & Technology (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Microbiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Diabetes (AREA)
- Oncology (AREA)
- Pain & Pain Management (AREA)
- Pulmonology (AREA)
- Dermatology (AREA)
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 (3)
| Publication Number | Publication Date |
|---|---|
| JP2019516964A JP2019516964A (ja) | 2019-06-20 |
| JP2019516964A5 JP2019516964A5 (enExample) | 2020-04-23 |
| JP7565147B2 true JP7565147B2 (ja) | 2024-10-10 |
Family
ID=58645011
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018553973A Active JP7565147B2 (ja) | 2016-04-14 | 2017-04-12 | 宿主細胞タンパク質の検出のための組成物及び方法 |
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) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL290358B2 (en) * | 2016-04-14 | 2024-03-01 | Lonza Ag | Preparations and methods for detecting 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 |
| WO2025224621A1 (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 |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005071410A1 (en) | 2004-01-13 | 2005-08-04 | Tanox, Inc. | Detecting and quantifying host cell proteins in recombinant protein products |
| JP2015533378A (ja) | 2012-10-30 | 2015-11-24 | エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft | 2段階接線流限外濾過を使用するポリペプチドの精製 |
Family Cites Families (22)
| Publication number | Priority date | Publication date | Assignee | Title |
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| FR2046920B1 (enExample) | 1969-06-19 | 1974-05-03 | Citizen Watch Co Ltd | |
| US3940475A (en) | 1970-06-11 | 1976-02-24 | Biological Developments, Inc. | Radioimmune method of assaying quantitatively for a hapten |
| US4737456A (en) | 1985-05-09 | 1988-04-12 | Syntex (U.S.A.) Inc. | Reducing interference in ligand-receptor binding assays |
| US5272071A (en) | 1989-12-22 | 1993-12-21 | Applied Research Systems Ars Holding N.V. | Method for the modification of the expression characteristics of an endogenous gene of a given cell line |
| GB9022545D0 (en) | 1990-10-17 | 1990-11-28 | Wellcome Found | Culture medium |
| US6797522B1 (en) * | 1994-01-13 | 2004-09-28 | The Trustees Of Columbia University In The City Of New York | Synthetic receptors |
| WO1998056915A2 (en) | 1997-06-12 | 1998-12-17 | Research Corporation Technologies, Inc. | Artificial antibody polypeptides |
| WO1999034220A2 (en) * | 1997-12-31 | 1999-07-08 | Genentech, Inc. | Real-time monitoring of an analyte by chromatography using an on-line assay |
| WO2001029058A1 (en) | 1999-10-15 | 2001-04-26 | University Of Massachusetts | Rna interference pathway genes as tools for targeted genetic interference |
| US6326193B1 (en) | 1999-11-05 | 2001-12-04 | Cambria Biosciences, Llc | Insect control agent |
| CN1321753A (zh) * | 2000-04-29 | 2001-11-14 | 上海博德基因开发有限公司 | 一种新的多肽——人b细胞蛋白酪氨酸激酶13和编码这种多肽的多核苷酸 |
| AU2001275474A1 (en) | 2000-06-12 | 2001-12-24 | Akkadix Corporation | Materials and methods for the control of nematodes |
| US20030091976A1 (en) * | 2001-11-14 | 2003-05-15 | Ciphergen Biosystems, Inc. | Methods for monitoring polypeptide production and purification using surface enhanced laser desorption/ionization mass spectrometry |
| US20060205010A1 (en) * | 2003-04-22 | 2006-09-14 | Catherine Allioux | Methods of host cell protein analysis |
| US8728828B2 (en) * | 2004-12-22 | 2014-05-20 | Ge Healthcare Bio-Sciences Ab | Purification of immunoglobulins |
| CN101571549B (zh) * | 2008-04-30 | 2013-08-14 | 上海泽润生物科技有限公司 | Vero细胞HCP检测试剂盒及其应用 |
| TWI610936B (zh) * | 2008-10-20 | 2018-01-11 | 艾伯維有限公司 | 使用蛋白質a親和性層析進行抗體之分離及純化 |
| CN103439512B (zh) * | 2013-07-30 | 2014-05-07 | 通化东宝药业股份有限公司 | 一种检测特异性重组人胰岛素大肠杆菌残留宿主蛋白的方法 |
| SG10201802525QA (en) | 2013-09-13 | 2018-04-27 | Genentech Inc | Methods and compositions comprising purified recombinant polypeptides |
| 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 |
| IL290358B2 (en) | 2016-04-14 | 2024-03-01 | Lonza Ag | Preparations and methods for detecting host cell proteins |
-
2017
- 2017-04-12 IL IL290358A patent/IL290358B2/en unknown
- 2017-04-12 WO PCT/EP2017/058775 patent/WO2017178526A1/en not_active Ceased
- 2017-04-12 SG SG11201808992UA patent/SG11201808992UA/en unknown
- 2017-04-12 EA EA201892325A patent/EA201892325A1/ru unknown
- 2017-04-12 US US16/093,253 patent/US11353468B2/en active Active
- 2017-04-12 KR KR1020187032543A patent/KR102408260B1/ko active Active
- 2017-04-12 CN CN201780034661.8A patent/CN109564217A/zh active Pending
- 2017-04-12 MX MX2018012550A patent/MX2018012550A/es unknown
- 2017-04-12 EP EP17720378.3A patent/EP3443348A1/en not_active Withdrawn
- 2017-04-12 JP JP2018553973A patent/JP7565147B2/ja active Active
- 2017-04-12 AU AU2017251360A patent/AU2017251360A1/en not_active Abandoned
- 2017-04-12 ES ES20160929T patent/ES2994760T3/es active Active
- 2017-04-12 CA CA3020808A patent/CA3020808A1/en not_active Abandoned
- 2017-04-12 BR BR112018071107-1A patent/BR112018071107A2/pt not_active Application Discontinuation
- 2017-04-12 CN CN202210618930.8A patent/CN115109148A/zh active Pending
- 2017-04-12 EP EP20160929.4A patent/EP3683579B1/en active Active
-
2018
- 2018-10-11 IL IL262297A patent/IL262297A/en unknown
-
2022
- 2022-05-03 US US17/735,555 patent/US20220268792A1/en active Pending
- 2022-05-03 US US17/735,524 patent/US12203948B2/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005071410A1 (en) | 2004-01-13 | 2005-08-04 | Tanox, Inc. | Detecting and quantifying host cell proteins in recombinant protein products |
| JP2015533378A (ja) | 2012-10-30 | 2015-11-24 | エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft | 2段階接線流限外濾過を使用するポリペプチドの精製 |
Non-Patent Citations (2)
| Title |
|---|
| Biotechnology and Bioengineering,2014年,Vol.111,No.12,pp.2367-2379 |
| USP 39:The United States Pharmacopeia;NF 34:The National Formulary:2016,USP 39 Published General Chapter,<1132>Residual Host Cell Protein Measurement in Biopharmaceuticals,Official:May 1,2016 |
Also Published As
| Publication number | Publication date |
|---|---|
| EA201892325A1 (ru) | 2019-04-30 |
| US11353468B2 (en) | 2022-06-07 |
| EP3443348A1 (en) | 2019-02-20 |
| CN115109148A (zh) | 2022-09-27 |
| KR102408260B1 (ko) | 2022-06-10 |
| MX2018012550A (es) | 2019-07-08 |
| CN109564217A (zh) | 2019-04-02 |
| EP3683579B1 (en) | 2024-10-23 |
| AU2017251360A1 (en) | 2018-11-01 |
| IL290358B2 (en) | 2024-03-01 |
| US12203948B2 (en) | 2025-01-21 |
| JP2019516964A (ja) | 2019-06-20 |
| EP3683579C0 (en) | 2024-10-23 |
| WO2017178526A1 (en) | 2017-10-19 |
| KR20180129927A (ko) | 2018-12-05 |
| US20220268792A1 (en) | 2022-08-25 |
| SG11201808992UA (en) | 2018-11-29 |
| US20220268791A1 (en) | 2022-08-25 |
| CA3020808A1 (en) | 2017-10-19 |
| BR112018071107A2 (pt) | 2019-04-16 |
| ES2994760T3 (en) | 2025-01-30 |
| IL290358A (en) | 2022-04-01 |
| EP3683579A1 (en) | 2020-07-22 |
| IL262297A (en) | 2018-11-29 |
| US20190128903A1 (en) | 2019-05-02 |
| IL290358B1 (en) | 2023-11-01 |
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