EA202091689A1 - Система и способ определения характеристик примесей, представляющих собой варианты, отличающиеся по размеру и заряду, в продукте, представляющем собой лекарственное средство - Google Patents
Система и способ определения характеристик примесей, представляющих собой варианты, отличающиеся по размеру и заряду, в продукте, представляющем собой лекарственное средствоInfo
- Publication number
- EA202091689A1 EA202091689A1 EA202091689A EA202091689A EA202091689A1 EA 202091689 A1 EA202091689 A1 EA 202091689A1 EA 202091689 A EA202091689 A EA 202091689A EA 202091689 A EA202091689 A EA 202091689A EA 202091689 A1 EA202091689 A1 EA 202091689A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- presenting
- charge
- size
- impurities
- medicinal
- Prior art date
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Classifications
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- 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
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- 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
Abstract
Предусмотрены системы и способы определения характеристик примесей, представляющих собой варианты, отличающиеся по размеру и заряду, в продукте, представляющем собой белковое лекарственное средство.
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 |
---|---|
EA202091689A1 true EA202091689A1 (ru) | 2020-10-22 |
Family
ID=65529777
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA202091689A EA202091689A1 (ru) | 2018-01-31 | 2019-01-28 | Система и способ определения характеристик примесей, представляющих собой варианты, отличающиеся по размеру и заряду, в продукте, представляющем собой лекарственное средство |
Country Status (15)
Country | Link |
---|---|
US (1) | US20190234959A1 (ru) |
EP (1) | EP3746471A1 (ru) |
JP (1) | JP7349998B2 (ru) |
KR (1) | KR20200115485A (ru) |
CN (1) | CN111655722A (ru) |
AR (1) | AR113731A1 (ru) |
AU (1) | AU2019215363A1 (ru) |
BR (1) | BR112020013336A2 (ru) |
CA (1) | CA3085177A1 (ru) |
EA (1) | EA202091689A1 (ru) |
IL (1) | IL276110A (ru) |
MX (1) | MX2020008095A (ru) |
SG (1) | SG11202005235WA (ru) |
TW (2) | TW201940507A (ru) |
WO (1) | WO2019152303A1 (ru) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA3125040A1 (en) * | 2019-01-25 | 2020-07-30 | Regeneron Pharmaceuticals, Inc. | Online chromatography and electrospray ionization mass spectrometer |
CA3174665A1 (en) * | 2020-04-09 | 2021-10-14 | 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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US7087411B2 (en) | 1999-06-08 | 2006-08-08 | Regeneron Pharmaceuticals, Inc. | Fusion protein capable of binding VEGF |
KR100562195B1 (ko) | 2002-03-08 | 2006-03-20 | 에이에스엠엘 네델란즈 비.브이. | 리소그래피용 마스크, 마스크 제조방법, 리소그래피장치및 디바이스제조방법 |
ATE537190T1 (de) | 2006-06-02 | 2011-12-15 | Regeneron Pharma | Hochaffine antikörper gegen den humanen il-6- rezeptor |
WO2008025747A1 (en) * | 2006-08-28 | 2008-03-06 | Ares Trading S.A. | 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 |
ES2426158T3 (es) * | 2007-01-22 | 2013-10-21 | Genentech, Inc. | Precipitación con polielectrolito y purificación de anticuerpos |
PL2178916T3 (pl) | 2007-07-31 | 2015-08-31 | Regeneron Pharma | Ludzkie przeciwciała przeciwko ludzkiemu CD20 i sposób ich zastosowania |
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). |
CN102471378B (zh) | 2009-06-26 | 2014-04-02 | 瑞泽恩制药公司 | 容易地分离的具有天然免疫球蛋白形式的双特异性抗体 |
JO3417B1 (ar) | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
TWI586806B (zh) * | 2010-04-23 | 2017-06-11 | 建南德克公司 | 異多聚體蛋白質之製造 |
JO3340B1 (ar) | 2010-05-26 | 2019-03-13 | Regeneron Pharma | مضادات حيوية لـعامل تمايز النمو 8 البشري |
JOP20190250A1 (ar) | 2010-07-14 | 2017-06-16 | Regeneron Pharma | صيغ مستقرة تحتوي على الأجسام المضادة لمضاد عامل نمو الأعصاب |
AR083044A1 (es) | 2010-09-27 | 2013-01-30 | Regeneron Pharma | Anticuerpos anti-cd48 y usos de los mismos |
PL2624865T3 (pl) | 2010-10-06 | 2018-11-30 | Regeneron Pharmaceuticals, Inc. | Stabilizowane preparaty zawierające przeciwciała przeciwko receptorowi interleukiny-4 (IL-4R) |
JO3756B1 (ar) | 2010-11-23 | 2021-01-31 | Regeneron Pharma | اجسام مضادة بشرية لمستقبلات الجلوكاجون |
JO3412B1 (ar) | 2011-06-17 | 2019-10-20 | Regeneron Pharma | أجسام مضادة ل angptl3 واستخداماتها |
KR102048189B1 (ko) | 2011-11-14 | 2019-11-25 | 리제너론 파아마슈티컬스, 인크. | Gdf8 및/또는 액티빈 a를 특이적으로 길항함으로써 근육량과 근육 강도를 증가시키는 조성물 및 방법 |
CN104169299B (zh) | 2012-01-23 | 2018-06-05 | 瑞泽恩制药公司 | 含抗Ang-2 抗体的稳定化制剂 |
JO3820B1 (ar) | 2012-05-03 | 2021-01-31 | Regeneron Pharma | أجسام مضادة بشرية لـ fel d1وطرق لاستخدامها |
TWI641619B (zh) | 2012-06-25 | 2018-11-21 | 美商再生元醫藥公司 | 抗-egfr抗體及其用途 |
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JOP20200236A1 (ar) | 2012-09-21 | 2017-06-16 | Regeneron Pharma | الأجسام المضادة لمضاد cd3 وجزيئات ربط الأنتيجين ثنائية التحديد التي تربط cd3 وcd20 واستخداماتها |
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TWI659968B (zh) | 2013-03-14 | 2019-05-21 | 再生元醫藥公司 | 針對呼吸道融合病毒f蛋白質的人類抗體及其使用方法 |
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TWI641620B (zh) | 2013-08-21 | 2018-11-21 | 再生元醫藥公司 | 抗-prlr抗體及其用途 |
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TWI680138B (zh) | 2014-01-23 | 2019-12-21 | 美商再生元醫藥公司 | 抗pd-l1之人類抗體 |
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SG11201606979TA (en) | 2014-03-11 | 2016-09-29 | Regeneron Pharma | Anti-egfrviii antibodies and uses thereof |
TWI754319B (zh) | 2014-03-19 | 2022-02-01 | 美商再生元醫藥公司 | 用於腫瘤治療之方法及抗體組成物 |
RU2020103811A (ru) | 2014-05-05 | 2020-02-18 | Регенерон Фармасьютикалз, Инк. | Гуманизированные животные по с5 и с3 |
JO3701B1 (ar) | 2014-05-23 | 2021-01-31 | Regeneron Pharma | مضادات حيوية بشرية لمتلازمة الشرق الأوسط التنفسية - بروتين كورونا فيروس الشوكي |
CA2960763A1 (en) | 2014-09-16 | 2016-03-24 | Regeneron Pharmaceuticals, Inc. | Anti-glucagon antibodies and uses thereof |
TWI710573B (zh) | 2015-01-26 | 2020-11-21 | 美商再生元醫藥公司 | 抗伊波拉病毒醣蛋白之人類抗體 |
-
2019
- 2019-01-28 WO PCT/US2019/015359 patent/WO2019152303A1/en unknown
- 2019-01-28 CA CA3085177A patent/CA3085177A1/en active Pending
- 2019-01-28 SG SG11202005235WA patent/SG11202005235WA/en unknown
- 2019-01-28 BR BR112020013336-1A patent/BR112020013336A2/pt unknown
- 2019-01-28 KR KR1020207019722A patent/KR20200115485A/ko not_active Application Discontinuation
- 2019-01-28 MX MX2020008095A patent/MX2020008095A/es unknown
- 2019-01-28 JP JP2020540755A patent/JP7349998B2/ja active Active
- 2019-01-28 CN CN201980007256.6A patent/CN111655722A/zh active Pending
- 2019-01-28 EA EA202091689A patent/EA202091689A1/ru unknown
- 2019-01-28 EP EP19707523.7A patent/EP3746471A1/en active Pending
- 2019-01-28 US US16/259,095 patent/US20190234959A1/en active Pending
- 2019-01-28 AU AU2019215363A patent/AU2019215363A1/en active Pending
- 2019-01-30 TW TW108103590A patent/TW201940507A/zh unknown
- 2019-01-30 TW TW112108439A patent/TW202325725A/zh unknown
- 2019-01-31 AR ARP190100231A patent/AR113731A1/es unknown
-
2020
- 2020-07-16 IL IL276110A patent/IL276110A/en unknown
Also Published As
Publication number | Publication date |
---|---|
WO2019152303A8 (en) | 2020-01-09 |
CN111655722A (zh) | 2020-09-11 |
TW202325725A (zh) | 2023-07-01 |
IL276110A (en) | 2020-08-31 |
AR113731A1 (es) | 2020-06-03 |
BR112020013336A2 (pt) | 2020-12-01 |
CA3085177A1 (en) | 2019-08-08 |
JP7349998B2 (ja) | 2023-09-25 |
KR20200115485A (ko) | 2020-10-07 |
JP2021512074A (ja) | 2021-05-13 |
TW201940507A (zh) | 2019-10-16 |
WO2019152303A1 (en) | 2019-08-08 |
EP3746471A1 (en) | 2020-12-09 |
SG11202005235WA (en) | 2020-07-29 |
AU2019215363A1 (en) | 2020-07-23 |
MX2020008095A (es) | 2020-09-24 |
US20190234959A1 (en) | 2019-08-01 |
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