Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab
Objectives. Developing reliable and accurate analytical methods is necessary for comparative pharmaceutical analysis using physicochemical, biological (in vitro), preclinical, and clinical trials. The main objective of this study was to develop and validate an in vitro method for determining the spe...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | Russian |
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MIREA - Russian Technological University
2020-05-01
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| Series: | Тонкие химические технологии |
| Subjects: | |
| Online Access: | https://www.finechem-mirea.ru/jour/article/view/1599 |
| _version_ | 1797881988332388352 |
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| author | D. I. Zybin A. S. Seregin A. D. Askretkov N. V. Orlova Yu. A. Seregin A. I. Prostyakova D. V. Kapustin |
| author_facet | D. I. Zybin A. S. Seregin A. D. Askretkov N. V. Orlova Yu. A. Seregin A. I. Prostyakova D. V. Kapustin |
| author_sort | D. I. Zybin |
| collection | DOAJ |
| description | Objectives. Developing reliable and accurate analytical methods is necessary for comparative pharmaceutical analysis using physicochemical, biological (in vitro), preclinical, and clinical trials. The main objective of this study was to develop and validate an in vitro method for determining the specific activity of the recombinant monoclonal antibody eculizumab.Methods. The method of indirect enzyme immunoassay was used in the study.Results. A method for determining the specific activity of the humanized recombinant monoclonal antibody eculizumab was described and validated for the first time. A comparative evaluation of the specific activity of Soliris® (Alexion Pharmaceuticals Inc., USA), and its biosimilar PRK-001 (Pharmapark, Russia) was performed using the developed method.Conclusions. The similarity of PRK-001 and the original Soliris® in relation to their specific activity, that is, binding to the human complement system C5 protein, was proved. |
| first_indexed | 2024-04-10T03:28:47Z |
| format | Article |
| id | doaj.art-9a8f1c5ef31d4e4b8d2d9e2114bf2262 |
| institution | Directory Open Access Journal |
| issn | 2410-6593 2686-7575 |
| language | Russian |
| last_indexed | 2024-04-10T03:28:47Z |
| publishDate | 2020-05-01 |
| publisher | MIREA - Russian Technological University |
| record_format | Article |
| series | Тонкие химические технологии |
| spelling | doaj.art-9a8f1c5ef31d4e4b8d2d9e2114bf22622023-03-13T07:25:39ZrusMIREA - Russian Technological UniversityТонкие химические технологии2410-65932686-75752020-05-01152778510.32362/2410-6593-2020-15-2-77-851589Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumabD. I. Zybin0A. S. Seregin1A. D. Askretkov2N. V. Orlova3Yu. A. Seregin4A. I. Prostyakova5D. V. Kapustin6PHARMAPARKScientific Center “Kurchatov Institute,” Research Institute for Genetics and Selection of Industrial MicroorganismsPHARMAPARKScientific Center “Kurchatov Institute,” Research Institute for Genetics and Selection of Industrial MicroorganismsScientific Center “Kurchatov Institute,” Research Institute for Genetics and Selection of Industrial MicroorganismsM.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of SciencesM.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of SciencesObjectives. Developing reliable and accurate analytical methods is necessary for comparative pharmaceutical analysis using physicochemical, biological (in vitro), preclinical, and clinical trials. The main objective of this study was to develop and validate an in vitro method for determining the specific activity of the recombinant monoclonal antibody eculizumab.Methods. The method of indirect enzyme immunoassay was used in the study.Results. A method for determining the specific activity of the humanized recombinant monoclonal antibody eculizumab was described and validated for the first time. A comparative evaluation of the specific activity of Soliris® (Alexion Pharmaceuticals Inc., USA), and its biosimilar PRK-001 (Pharmapark, Russia) was performed using the developed method.Conclusions. The similarity of PRK-001 and the original Soliris® in relation to their specific activity, that is, binding to the human complement system C5 protein, was proved.https://www.finechem-mirea.ru/jour/article/view/1599validationparoxysmal nocturnal hemoglobinuriareproduced drugspecific in vitro activityenzyme-linked immunosorbent assaycomplement system |
| spellingShingle | D. I. Zybin A. S. Seregin A. D. Askretkov N. V. Orlova Yu. A. Seregin A. I. Prostyakova D. V. Kapustin Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab Тонкие химические технологии validation paroxysmal nocturnal hemoglobinuria reproduced drug specific in vitro activity enzyme-linked immunosorbent assay complement system |
| title | Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab |
| title_full | Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab |
| title_fullStr | Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab |
| title_full_unstemmed | Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab |
| title_short | Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab |
| title_sort | development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab |
| topic | validation paroxysmal nocturnal hemoglobinuria reproduced drug specific in vitro activity enzyme-linked immunosorbent assay complement system |
| url | https://www.finechem-mirea.ru/jour/article/view/1599 |
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