SG11202005235WA - System and method for characterizing size and charge variant drug product impurities - Google Patents
System and method for characterizing size and charge variant drug product impuritiesInfo
- Publication number
- SG11202005235WA SG11202005235WA SG11202005235WA SG11202005235WA SG11202005235WA SG 11202005235W A SG11202005235W A SG 11202005235WA SG 11202005235W A SG11202005235W A SG 11202005235WA SG 11202005235W A SG11202005235W A SG 11202005235WA SG 11202005235W A SG11202005235W A SG 11202005235WA
- Authority
- SG
- Singapore
- Prior art keywords
- drug product
- charge variant
- product impurities
- characterizing size
- variant drug
- Prior art date
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 That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
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 |
---|---|
SG11202005235WA true SG11202005235WA (en) | 2020-07-29 |
Family
ID=65529777
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
SG11202005235WA SG11202005235WA (en) | 2018-01-31 | 2019-01-28 | System and method for characterizing size and charge variant drug product impurities |
Country Status (15)
Country | Link |
---|---|
US (1) | US20190234959A1 (ja) |
EP (1) | EP3746471A1 (ja) |
JP (1) | JP7349998B2 (ja) |
KR (1) | KR20200115485A (ja) |
CN (1) | CN111655722A (ja) |
AR (1) | AR113731A1 (ja) |
AU (1) | AU2019215363A1 (ja) |
BR (1) | BR112020013336A2 (ja) |
CA (1) | CA3085177A1 (ja) |
EA (1) | EA202091689A1 (ja) |
IL (1) | IL276110A (ja) |
MX (1) | MX2020008095A (ja) |
SG (1) | SG11202005235WA (ja) |
TW (2) | TW202325725A (ja) |
WO (1) | WO2019152303A1 (ja) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN113301974A (zh) | 2019-01-25 | 2021-08-24 | 瑞泽恩制药公司 | 在线色谱法和电喷雾电离质谱仪 |
WO2021207657A1 (en) * | 2020-04-09 | 2021-10-14 | Cytomx Therapeutics, Inc. | Compositions containing activatable antibodies |
IL310875A (en) * | 2021-09-14 | 2024-04-01 | Regeneron Pharma | NMASS spectrometry-based strategy for characterizing high molecular weight species of a biological product |
Family Cites Families (38)
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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 |
US7582298B2 (en) | 2006-06-02 | 2009-09-01 | Regeneron Pharmaceuticals, Inc. | High affinity antibodies to human IL-6 receptor |
US20100267932A1 (en) * | 2006-08-28 | 2010-10-21 | Alex Eon-Duval | 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 |
EP2120915B1 (en) * | 2007-01-22 | 2011-09-28 | Genentech, Inc. | Polyelectrolyte precipitation and purification of antibodies |
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). |
RU2522002C2 (ru) | 2009-06-26 | 2014-07-10 | Ридженерон Фармасьютикалз, Инк. | Легковыделяемые биспецифические антитела с природным иммуноглобулиновым форматом |
JO3417B1 (ar) | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
RU2624027C2 (ru) * | 2010-04-23 | 2017-06-30 | Дженентек, Инк. | Получение гетеромультимерных белков |
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 |
US8945559B2 (en) | 2010-10-06 | 2015-02-03 | Regeneron Pharmaceuticals, Inc. | Stabilized formulations containing anti-interleukin-4 receptor (IL-4R) antibodies |
JO3756B1 (ar) | 2010-11-23 | 2021-01-31 | Regeneron Pharma | اجسام مضادة بشرية لمستقبلات الجلوكاجون |
AR087329A1 (es) | 2011-06-17 | 2014-03-19 | Regeneron Pharma | Anticuerpos humanos contra proteina 3 de tipo angiopoietina humana |
PL2780368T3 (pl) | 2011-11-14 | 2018-06-29 | Regeneron Pharmaceuticals, Inc. | Kompozycje i sposoby do zwiększania masy mięśni i siły mięśni poprzez swoiste antaganizowanie GDF8 i/lub aktywiny A |
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 |
TW201843172A (zh) | 2012-06-25 | 2018-12-16 | 美商再生元醫藥公司 | 抗-egfr抗體及其用途 |
CA2881679C (en) | 2012-08-13 | 2021-01-26 | Regeneron Pharmaceuticals, Inc. | Anti-pcsk9 antibodies with ph-dependent binding characteristics |
JOP20200236A1 (ar) | 2012-09-21 | 2017-06-16 | Regeneron Pharma | الأجسام المضادة لمضاد cd3 وجزيئات ربط الأنتيجين ثنائية التحديد التي تربط cd3 وcd20 واستخداماتها |
JO3405B1 (ar) | 2013-01-09 | 2019-10-20 | Regeneron Pharma | الأجسام المضادة لمضاد مستقبل عامل النمو المشتق من الصفائح الدموية - بيتا واستخداماتها |
JO3532B1 (ar) | 2013-03-13 | 2020-07-05 | Regeneron Pharma | الأجسام المضادة لمضاد انترلوكين-33 واستعمالاتها |
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 |
JP6404314B2 (ja) | 2013-03-15 | 2018-10-10 | リジェネロン・ファーマシューティカルズ・インコーポレイテッドRegeneron Pharmaceuticals, Inc. | Il−33拮抗薬とその使用法 |
TWI641620B (zh) | 2013-08-21 | 2018-11-21 | 再生元醫藥公司 | 抗-prlr抗體及其用途 |
EP3060578A4 (en) * | 2013-10-25 | 2017-07-05 | Medlmmune, LLC | Antibody purification |
TWI681969B (zh) | 2014-01-23 | 2020-01-11 | 美商再生元醫藥公司 | 針對pd-1的人類抗體 |
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 |
CA2940685C (en) | 2014-03-11 | 2023-10-24 | Regeneron Pharmaceuticals, Inc. | 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 |
WO2015171523A1 (en) | 2014-05-05 | 2015-11-12 | Regeneron Pharmaceuticals, Inc. | Humanized c5 and c3 animals |
JO3701B1 (ar) | 2014-05-23 | 2021-01-31 | Regeneron Pharma | مضادات حيوية بشرية لمتلازمة الشرق الأوسط التنفسية - بروتين كورونا فيروس الشوكي |
SG11201701711VA (en) | 2014-09-16 | 2017-04-27 | Regeneron Pharma | 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 AU AU2019215363A patent/AU2019215363A1/en active Pending
- 2019-01-28 US US16/259,095 patent/US20190234959A1/en not_active Abandoned
- 2019-01-28 WO PCT/US2019/015359 patent/WO2019152303A1/en unknown
- 2019-01-28 EA EA202091689A patent/EA202091689A1/ru unknown
- 2019-01-28 EP EP19707523.7A patent/EP3746471A1/en active Pending
- 2019-01-28 KR KR1020207019722A patent/KR20200115485A/ko not_active Application Discontinuation
- 2019-01-28 CN CN201980007256.6A patent/CN111655722A/zh active Pending
- 2019-01-28 SG SG11202005235WA patent/SG11202005235WA/en unknown
- 2019-01-28 JP JP2020540755A patent/JP7349998B2/ja active Active
- 2019-01-28 BR BR112020013336-1A patent/BR112020013336A2/pt unknown
- 2019-01-28 CA CA3085177A patent/CA3085177A1/en active Pending
- 2019-01-28 MX MX2020008095A patent/MX2020008095A/es unknown
- 2019-01-30 TW TW112108439A patent/TW202325725A/zh unknown
- 2019-01-30 TW TW108103590A patent/TW201940507A/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 |
---|---|
TW202325725A (zh) | 2023-07-01 |
EP3746471A1 (en) | 2020-12-09 |
IL276110A (en) | 2020-08-31 |
WO2019152303A1 (en) | 2019-08-08 |
MX2020008095A (es) | 2020-09-24 |
CA3085177A1 (en) | 2019-08-08 |
WO2019152303A8 (en) | 2020-01-09 |
EA202091689A1 (ru) | 2020-10-22 |
CN111655722A (zh) | 2020-09-11 |
TW201940507A (zh) | 2019-10-16 |
AR113731A1 (es) | 2020-06-03 |
BR112020013336A2 (pt) | 2020-12-01 |
JP2021512074A (ja) | 2021-05-13 |
JP7349998B2 (ja) | 2023-09-25 |
AU2019215363A1 (en) | 2020-07-23 |
US20190234959A1 (en) | 2019-08-01 |
KR20200115485A (ko) | 2020-10-07 |
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