QUANTITATIVE DETERMINATION OF HOST CELL PROTEINS (CHO) BY THE METHOD OF ENZYME IMMUNOASSAY IN THE PROTEIN ADALIMUMAB
Is necessary to ensure thorough purification of the target proteins, since the presence of host cell proteins (HCP) from CHO cells in the final product is fraught with a number of negative consequences. Thus, it is has to reduce the contamination of HCP to minimum levels. A comparison of the immunoe...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
|
| Series: | Разработка и регистрация лекарственных средств |
| Subjects: | |
| Online Access: | https://www.pharmjournal.ru/jour/article/view/513 |
| _version_ | 1826569757702225920 |
|---|---|
| author | P. M. Isaykina V. P. Dolgova A. D. Ascretcov N. V. Orlova |
| author_facet | P. M. Isaykina V. P. Dolgova A. D. Ascretcov N. V. Orlova |
| author_sort | P. M. Isaykina |
| collection | DOAJ |
| description | Is necessary to ensure thorough purification of the target proteins, since the presence of host cell proteins (HCP) from CHO cells in the final product is fraught with a number of negative consequences. Thus, it is has to reduce the contamination of HCP to minimum levels. A comparison of the immunoenzymatic assays of the second and third generations of Cygnus technologies for the quantification of host cell proteins (CHO) in a monoclonal antibody adalimumab was done. It was found that a kit of the 2nd generation does not show the true level of the host cell proteins, underestimating the result. In this connection, it becomes necessary to confirm the validity of the method for determining the total quantity of host cell proteins (CHO) by a set of 3rd generation in adalimumab substance according to the following analytical characteristics: system suitability test, specificity, limit of detection, limit of quantitation, hook capacity, precision. |
| first_indexed | 2024-04-10T01:40:23Z |
| format | Article |
| id | doaj.art-862c2a8485ea4868912a2be841084fb6 |
| institution | Directory Open Access Journal |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| last_indexed | 2025-03-14T11:44:25Z |
| publishDate | 2019-01-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj.art-862c2a8485ea4868912a2be841084fb62025-03-02T09:53:20ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-0104166175513QUANTITATIVE DETERMINATION OF HOST CELL PROTEINS (CHO) BY THE METHOD OF ENZYME IMMUNOASSAY IN THE PROTEIN ADALIMUMABP. M. Isaykina0V. P. Dolgova1A. D. Ascretcov2N. V. Orlova3Moscow Technological University (Institute of fine chemical technologies)Scientific Center of Russian Federation Research Institute for Genetics and Selection of Industrial MicroorganismsMoscow Technological University (Institute of fine chemical technologies)Scientific Center of Russian Federation Research Institute for Genetics and Selection of Industrial MicroorganismsIs necessary to ensure thorough purification of the target proteins, since the presence of host cell proteins (HCP) from CHO cells in the final product is fraught with a number of negative consequences. Thus, it is has to reduce the contamination of HCP to minimum levels. A comparison of the immunoenzymatic assays of the second and third generations of Cygnus technologies for the quantification of host cell proteins (CHO) in a monoclonal antibody adalimumab was done. It was found that a kit of the 2nd generation does not show the true level of the host cell proteins, underestimating the result. In this connection, it becomes necessary to confirm the validity of the method for determining the total quantity of host cell proteins (CHO) by a set of 3rd generation in adalimumab substance according to the following analytical characteristics: system suitability test, specificity, limit of detection, limit of quantitation, hook capacity, precision.https://www.pharmjournal.ru/jour/article/view/513adalimumabmonoclonal antibodiesenzyme immunoassayhost cell proteins (cho)elisavalidation |
| spellingShingle | P. M. Isaykina V. P. Dolgova A. D. Ascretcov N. V. Orlova QUANTITATIVE DETERMINATION OF HOST CELL PROTEINS (CHO) BY THE METHOD OF ENZYME IMMUNOASSAY IN THE PROTEIN ADALIMUMAB Разработка и регистрация лекарственных средств adalimumab monoclonal antibodies enzyme immunoassay host cell proteins (cho) elisa validation |
| title | QUANTITATIVE DETERMINATION OF HOST CELL PROTEINS (CHO) BY THE METHOD OF ENZYME IMMUNOASSAY IN THE PROTEIN ADALIMUMAB |
| title_full | QUANTITATIVE DETERMINATION OF HOST CELL PROTEINS (CHO) BY THE METHOD OF ENZYME IMMUNOASSAY IN THE PROTEIN ADALIMUMAB |
| title_fullStr | QUANTITATIVE DETERMINATION OF HOST CELL PROTEINS (CHO) BY THE METHOD OF ENZYME IMMUNOASSAY IN THE PROTEIN ADALIMUMAB |
| title_full_unstemmed | QUANTITATIVE DETERMINATION OF HOST CELL PROTEINS (CHO) BY THE METHOD OF ENZYME IMMUNOASSAY IN THE PROTEIN ADALIMUMAB |
| title_short | QUANTITATIVE DETERMINATION OF HOST CELL PROTEINS (CHO) BY THE METHOD OF ENZYME IMMUNOASSAY IN THE PROTEIN ADALIMUMAB |
| title_sort | quantitative determination of host cell proteins cho by the method of enzyme immunoassay in the protein adalimumab |
| topic | adalimumab monoclonal antibodies enzyme immunoassay host cell proteins (cho) elisa validation |
| url | https://www.pharmjournal.ru/jour/article/view/513 |
| work_keys_str_mv | AT pmisaykina quantitativedeterminationofhostcellproteinschobythemethodofenzymeimmunoassayintheproteinadalimumab AT vpdolgova quantitativedeterminationofhostcellproteinschobythemethodofenzymeimmunoassayintheproteinadalimumab AT adascretcov quantitativedeterminationofhostcellproteinschobythemethodofenzymeimmunoassayintheproteinadalimumab AT nvorlova quantitativedeterminationofhostcellproteinschobythemethodofenzymeimmunoassayintheproteinadalimumab |