EA202091555A1 - SYSTEM AND METHOD FOR DETERMINING THE CHARACTERISTICS OF IMPURITIES OF A MEDICINAL PREPARATION - Google Patents
SYSTEM AND METHOD FOR DETERMINING THE CHARACTERISTICS OF IMPURITIES OF A MEDICINAL PREPARATIONInfo
- Publication number
- EA202091555A1 EA202091555A1 EA202091555A EA202091555A EA202091555A1 EA 202091555 A1 EA202091555 A1 EA 202091555A1 EA 202091555 A EA202091555 A EA 202091555A EA 202091555 A EA202091555 A EA 202091555A EA 202091555 A1 EA202091555 A1 EA 202091555A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- impurities
- drug
- compounds
- chpv
- sds
- Prior art date
Links
Landscapes
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
Предложены системы и способы для определения характеристик низкомолекулярных (НМ) примесей белкового лекарственного препарата. В одном варианте осуществления используется хроматография гидрофильных взаимодействий (ХГФВ) в комбинации с масс-спектрометрическим анализом. После удаления N-связанных гликанов из белкового лекарственного препарата, например лекарственного препарата на основе антител, элюирование НМ примесей из колонки для ХГФВ определяли по величине молекулярной массы соединений. В некоторых вариантах осуществления разделение методом ХГФВ выполняют в денатурирующих условиях, что делает обнаружение НМ форм с использованием этого метода в высокой степени сопоставимым с методами ДСН-ПААГ-электрофореза и CE-SDS. НМ примеси лекарственного препарата включают, но не ограничиваются ими, соединения легкой цепи, полуантитела, H2L, H2, HL, HC, соединения с укороченным пептидным остовом и их комбинации.Systems and methods for characterization of low molecular weight (LM) impurities of a protein drug are proposed. In one embodiment, hydrophilic interaction chromatography (HCIP) is used in combination with mass spectrometric analysis. After removing N-linked glycans from a protein drug, eg, an antibody drug, the elution of LM impurities from the CHPV column was determined by the molecular weight of the compounds. In some embodiments, the implementation of the separation by the method of CHPV is performed under denaturing conditions, which makes the detection of LM forms using this method is highly comparable with the methods of SDS-PAGE electrophoresis and CE-SDS. LMD drug impurities include, but are not limited to, light chain compounds, semi-antibodies, H2L, H2, HL, HC, truncated peptide backbone compounds, and combinations thereof.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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 |
|---|---|
| EA202091555A1 true EA202091555A1 (en) | 2020-09-21 |
Family
ID=72616036
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA202091555A EA202091555A1 (en) | 2018-10-10 | 2018-12-18 | SYSTEM AND METHOD FOR DETERMINING THE CHARACTERISTICS OF IMPURITIES OF A MEDICINAL PREPARATION |
Country Status (1)
| Country | Link |
|---|---|
| EA (1) | EA202091555A1 (en) |
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2018
- 2018-12-18 EA EA202091555A patent/EA202091555A1/en unknown
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