Validation of Protein A chromatography: orthogonal method with size exclusion chromatography validation for mAb titer analysis
After reviewing the reference product specifications, found that they include the SEC HPLC result but do not specify Protein A chromatography as a test. Although there is no record of reference product specifications, alternative methods are necessary, particularly for routine analysis of biotechnol...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
De Gruyter
2025-05-01
|
| Series: | Türk Biyokimya Dergisi |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/tjb-2024-0186 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849251772914204672 |
|---|---|
| author | Sahinkaya Elif Ozkan Aylin Ozdemir Nilay Aslan Merve Elif Bicak Dilan Cakir Nilufer Oncel Hatice Yetimoglu Ece Kok |
| author_facet | Sahinkaya Elif Ozkan Aylin Ozdemir Nilay Aslan Merve Elif Bicak Dilan Cakir Nilufer Oncel Hatice Yetimoglu Ece Kok |
| author_sort | Sahinkaya Elif |
| collection | DOAJ |
| description | After reviewing the reference product specifications, found that they include the SEC HPLC result but do not specify Protein A chromatography as a test. Although there is no record of reference product specifications, alternative methods are necessary, particularly for routine analysis of biotechnological products. |
| format | Article |
| id | doaj-art-68a73f8df84e4ac8b82a0def0a6296a0 |
| institution | Kabale University |
| issn | 1303-829X |
| language | English |
| publishDate | 2025-05-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Türk Biyokimya Dergisi |
| spelling | doaj-art-68a73f8df84e4ac8b82a0def0a6296a02025-08-20T03:56:49ZengDe GruyterTürk Biyokimya Dergisi1303-829X2025-05-0150344044810.1515/tjb-2024-0186Validation of Protein A chromatography: orthogonal method with size exclusion chromatography validation for mAb titer analysisSahinkaya Elif0Ozkan Aylin1Ozdemir Nilay2Aslan Merve Elif3Bicak Dilan4Cakir Nilufer5Oncel Hatice6Yetimoglu Ece Kok7Department of Analytical Chemistry, Marmara University, Istanbul, TurkiyeBiotechnology Analytical Development Department of Ilko Argem Biotechnology Center, Teknopark, Istanbul, TurkiyeBiotechnology Analytical Development Department of Ilko Argem Biotechnology Center, Teknopark, Istanbul, TurkiyeBiotechnology Analytical Development Department of Ilko Argem Biotechnology Center, Teknopark, Istanbul, TurkiyeBiotechnology Analytical Development Department of Ilko Argem Biotechnology Center, Teknopark, Istanbul, TurkiyeBiotechnology Analytical Development Department of Ilko Argem Biotechnology Center, Teknopark, Istanbul, TurkiyeBiotechnology Department of Ilko Argem Biotechnology Center, Teknopark, Istanbul, TurkiyeDepartment of Analytical Chemistry, Marmara University, Istanbul, TurkiyeAfter reviewing the reference product specifications, found that they include the SEC HPLC result but do not specify Protein A chromatography as a test. Although there is no record of reference product specifications, alternative methods are necessary, particularly for routine analysis of biotechnological products.https://doi.org/10.1515/tjb-2024-0186monoclonal antibodybioanalytical method developmentbioanalytical method validationbiotechnologychromatographyich m10 guideline |
| spellingShingle | Sahinkaya Elif Ozkan Aylin Ozdemir Nilay Aslan Merve Elif Bicak Dilan Cakir Nilufer Oncel Hatice Yetimoglu Ece Kok Validation of Protein A chromatography: orthogonal method with size exclusion chromatography validation for mAb titer analysis Türk Biyokimya Dergisi monoclonal antibody bioanalytical method development bioanalytical method validation biotechnology chromatography ich m10 guideline |
| title | Validation of Protein A chromatography: orthogonal method with size exclusion chromatography validation for mAb titer analysis |
| title_full | Validation of Protein A chromatography: orthogonal method with size exclusion chromatography validation for mAb titer analysis |
| title_fullStr | Validation of Protein A chromatography: orthogonal method with size exclusion chromatography validation for mAb titer analysis |
| title_full_unstemmed | Validation of Protein A chromatography: orthogonal method with size exclusion chromatography validation for mAb titer analysis |
| title_short | Validation of Protein A chromatography: orthogonal method with size exclusion chromatography validation for mAb titer analysis |
| title_sort | validation of protein a chromatography orthogonal method with size exclusion chromatography validation for mab titer analysis |
| topic | monoclonal antibody bioanalytical method development bioanalytical method validation biotechnology chromatography ich m10 guideline |
| url | https://doi.org/10.1515/tjb-2024-0186 |
| work_keys_str_mv | AT sahinkayaelif validationofproteinachromatographyorthogonalmethodwithsizeexclusionchromatographyvalidationformabtiteranalysis AT ozkanaylin validationofproteinachromatographyorthogonalmethodwithsizeexclusionchromatographyvalidationformabtiteranalysis AT ozdemirnilay validationofproteinachromatographyorthogonalmethodwithsizeexclusionchromatographyvalidationformabtiteranalysis AT aslanmerveelif validationofproteinachromatographyorthogonalmethodwithsizeexclusionchromatographyvalidationformabtiteranalysis AT bicakdilan validationofproteinachromatographyorthogonalmethodwithsizeexclusionchromatographyvalidationformabtiteranalysis AT cakirnilufer validationofproteinachromatographyorthogonalmethodwithsizeexclusionchromatographyvalidationformabtiteranalysis AT oncelhatice validationofproteinachromatographyorthogonalmethodwithsizeexclusionchromatographyvalidationformabtiteranalysis AT yetimogluecekok validationofproteinachromatographyorthogonalmethodwithsizeexclusionchromatographyvalidationformabtiteranalysis |