MX2020006639A - Sistema y metodo para caracterizar las impurezas de un producto farmaceutico. - Google Patents
Sistema y metodo para caracterizar las impurezas de un producto farmaceutico.Info
- Publication number
- MX2020006639A MX2020006639A MX2020006639A MX2020006639A MX2020006639A MX 2020006639 A MX2020006639 A MX 2020006639A MX 2020006639 A MX2020006639 A MX 2020006639A MX 2020006639 A MX2020006639 A MX 2020006639A MX 2020006639 A MX2020006639 A MX 2020006639A
- Authority
- MX
- Mexico
- Prior art keywords
- drug product
- lmw
- hilic
- impurities
- molecular weight
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- 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
- B01D15/30—Partition chromatography
- B01D15/305—Hydrophilic interaction chromatography [HILIC]
-
- 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
-
- 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
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
-
- 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
- G01N33/6857—Antibody fragments
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
-
- 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
- C07K2319/00—Fusion polypeptide
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6869—Methods for sequencing
- C12Q1/6872—Methods for sequencing involving mass spectrometry
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y305/00—Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5)
- C12Y305/01—Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5) in linear amides (3.5.1)
- C12Y305/01052—Peptide-N4-(N-acetyl-beta-glucosaminyl)asparagine amidase (3.5.1.52), i.e. glycopeptidase
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N2030/022—Column chromatography characterised by the kind of separation mechanism
- G01N2030/027—Liquid chromatography
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
- G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
- G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
- G01N2030/8831—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins
-
- 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
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Medicinal Chemistry (AREA)
- Biophysics (AREA)
- Engineering & Computer Science (AREA)
- Analytical Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Food Science & Technology (AREA)
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
Se proporcionan sistemas y métodos para caracterizar impurezas de bajo peso molecular (LMW) del producto farmacéutico proteínico. Una modalidad utiliza la cromatografía de interacción hidrofílica (HILIC) acoplada al análisis de espectrometría de masas. Después de remover los glicanos enlazados a N del producto farmacéutico proteínico, por ejemplo, un producto farmacéutico de anticuerpo, se determinó la elución de impurezas de LMW de la columna de HILIC según el tamaño de la especie de peso molecular. En algunas modalidades, la separación por HILIC se lleva a cabo en condiciones de desnaturalización, lo que hace que la detección de formas de LMW mediante este método sea altamente comparable con los métodos SDS-PAGE y CE-SDS. Las impurezas de LMW del producto farmacéutico incluyen, de modo no taxativo, cadena ligera, medio anticuerpo, H2L, H2, HL, HC, especie truncada por la cadena principal del péptido, y combinaciones de estos.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762610029P | 2017-12-22 | 2017-12-22 | |
US201862743632P | 2018-10-10 | 2018-10-10 | |
PCT/US2018/066160 WO2019126123A1 (en) | 2017-12-22 | 2018-12-18 | System and method for characterizing drug product impurities |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2020006639A true MX2020006639A (es) | 2020-09-14 |
Family
ID=65201678
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2020006639A MX2020006639A (es) | 2017-12-22 | 2018-12-18 | Sistema y metodo para caracterizar las impurezas de un producto farmaceutico. |
Country Status (14)
Country | Link |
---|---|
US (2) | US20190194298A1 (es) |
EP (1) | EP3727629A1 (es) |
JP (2) | JP7321159B2 (es) |
KR (1) | KR20200103728A (es) |
CN (2) | CN111479618B (es) |
AR (1) | AR114045A1 (es) |
AU (1) | AU2018392334A1 (es) |
BR (1) | BR112020010615A2 (es) |
CA (1) | CA3084059A1 (es) |
IL (1) | IL275404A (es) |
MX (1) | MX2020006639A (es) |
SG (1) | SG11202004380QA (es) |
TW (2) | TW202402787A (es) |
WO (1) | WO2019126123A1 (es) |
Family Cites Families (39)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7087411B2 (en) | 1999-06-08 | 2006-08-08 | Regeneron Pharmaceuticals, Inc. | Fusion protein capable of binding VEGF |
SG106672A1 (en) | 2002-03-08 | 2004-10-29 | Asml Netherlands Bv | Mask for use in lithography, method of making a mask, lithographic apparatus, and device manufacturing method |
ES2558303T3 (es) * | 2002-09-11 | 2016-02-03 | Chugai Seiyaku Kabushiki Kaisha | Método de purificación de proteínas |
EP1581644B1 (en) * | 2003-01-09 | 2007-06-06 | Genentech, Inc. | Purification of polypeptides |
MX2008014804A (es) | 2006-06-02 | 2009-01-27 | Regeneron Pharma | Anticuerpos de afinidad elevada a receptor de il-6 humano. |
US7608693B2 (en) | 2006-10-02 | 2009-10-27 | Regeneron Pharmaceuticals, Inc. | High affinity human antibodies to human IL-4 receptor |
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). |
AU2010265933B2 (en) | 2009-06-26 | 2015-05-14 | Regeneron Pharmaceuticals, Inc. | Readily isolated bispecific antibodies with native immunoglobulin format |
JO3417B1 (ar) | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
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 |
NZ609557A (en) | 2010-10-06 | 2014-12-24 | Regeneron Pharma | 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 |
JO3412B1 (ar) | 2011-06-17 | 2019-10-20 | Regeneron Pharma | أجسام مضادة ل angptl3 واستخداماتها |
ES2663946T3 (es) | 2011-11-14 | 2018-04-17 | Regeneron Pharmaceuticals, Inc. | Composiciones y métodos para aumentar la masa y la fuerza muscular antagonizando específicamente GDF8 y/o Activina A |
SG11201403792TA (en) | 2012-01-23 | 2014-10-30 | Regeneron Pharma | Stabilized formulations containing anti-ang2 antibodies |
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 |
WO2014028354A1 (en) | 2012-08-13 | 2014-02-20 | 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 |
EA034834B1 (ru) | 2013-03-15 | 2020-03-26 | Ридженерон Фармасьютикалз, Инк. | Антагонисты il-33 и их применение |
TWI641620B (zh) | 2013-08-21 | 2018-11-21 | 再生元醫藥公司 | 抗-prlr抗體及其用途 |
JP2016538267A (ja) | 2013-10-25 | 2016-12-08 | メディミューン,エルエルシー | 抗体精製 |
US10119944B2 (en) * | 2013-12-24 | 2018-11-06 | Waters Technologies Corporation | Materials for hydrophilic interaction chromatography and processes for preparation and use thereof for analysis of glycoproteins and glycopeptides |
US11092574B2 (en) * | 2013-12-24 | 2021-08-17 | Waters Technologies Corporation | Materials for hydrophilic interaction chromatography and processes for preparation and use thereof for analysis of glycoproteins and glycopeptides |
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 |
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 |
PL3126388T3 (pl) | 2014-03-11 | 2019-10-31 | Regeneron Pharma | Przeciwciała anty-egfrviii i ich zastosowania |
TWI701042B (zh) | 2014-03-19 | 2020-08-11 | 美商再生元醫藥公司 | 用於腫瘤治療之方法及抗體組成物 |
CA3225091A1 (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 |
-
2018
- 2018-12-18 EP EP18839652.7A patent/EP3727629A1/en active Pending
- 2018-12-18 WO PCT/US2018/066160 patent/WO2019126123A1/en unknown
- 2018-12-18 SG SG11202004380QA patent/SG11202004380QA/en unknown
- 2018-12-18 JP JP2020528963A patent/JP7321159B2/ja active Active
- 2018-12-18 MX MX2020006639A patent/MX2020006639A/es unknown
- 2018-12-18 BR BR112020010615-1A patent/BR112020010615A2/pt unknown
- 2018-12-18 AU AU2018392334A patent/AU2018392334A1/en active Pending
- 2018-12-18 CA CA3084059A patent/CA3084059A1/en active Pending
- 2018-12-18 KR KR1020207020506A patent/KR20200103728A/ko not_active Application Discontinuation
- 2018-12-18 CN CN201880080694.0A patent/CN111479618B/zh active Active
- 2018-12-18 US US16/223,463 patent/US20190194298A1/en not_active Abandoned
- 2018-12-18 CN CN202210854039.4A patent/CN115925882A/zh active Pending
- 2018-12-20 TW TW112134231A patent/TW202402787A/zh unknown
- 2018-12-20 TW TW107146068A patent/TWI811277B/zh active
- 2018-12-21 AR ARP180103833A patent/AR114045A1/es unknown
-
2020
- 2020-06-15 IL IL275404A patent/IL275404A/en unknown
-
2022
- 2022-02-22 US US17/677,499 patent/US20220169704A1/en active Pending
-
2023
- 2023-07-25 JP JP2023120393A patent/JP2023139186A/ja active Pending
Also Published As
Publication number | Publication date |
---|---|
EP3727629A1 (en) | 2020-10-28 |
US20190194298A1 (en) | 2019-06-27 |
SG11202004380QA (en) | 2020-06-29 |
WO2019126123A1 (en) | 2019-06-27 |
KR20200103728A (ko) | 2020-09-02 |
CN115925882A (zh) | 2023-04-07 |
JP7321159B2 (ja) | 2023-08-04 |
CA3084059A1 (en) | 2019-06-27 |
TW201938581A (zh) | 2019-10-01 |
TW202402787A (zh) | 2024-01-16 |
BR112020010615A2 (pt) | 2020-10-27 |
TWI811277B (zh) | 2023-08-11 |
IL275404A (en) | 2020-07-30 |
CN111479618A (zh) | 2020-07-31 |
JP2023139186A (ja) | 2023-10-03 |
AR114045A1 (es) | 2020-07-15 |
CN111479618B (zh) | 2022-08-02 |
US20220169704A1 (en) | 2022-06-02 |
JP2021507878A (ja) | 2021-02-25 |
AU2018392334A1 (en) | 2020-05-28 |
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