Ayca Zeybek Kuyucu, Dogu Sayili, Ridvan Orkut, Olcay Mert, İbrahim Oguzhan Tarman, Busra Lulaci, Ali Mert Sencer, Asli Kurden Pekmezci, Mehmet Ender Avci, Sibel Kalyoncu, Mehmet Inan
{"title":"阿特唑单抗生物仿制药的细胞系开发和生物反应器工艺优化。","authors":"Ayca Zeybek Kuyucu, Dogu Sayili, Ridvan Orkut, Olcay Mert, İbrahim Oguzhan Tarman, Busra Lulaci, Ali Mert Sencer, Asli Kurden Pekmezci, Mehmet Ender Avci, Sibel Kalyoncu, Mehmet Inan","doi":"10.1002/bab.2704","DOIUrl":null,"url":null,"abstract":"<p><p>Checkpoint inhibitors are widely recognized immunotherapeutic drugs, known for their effectiveness in treating various cancers. Atezolizumab, targeting the immune checkpoint programmed death-ligand 1, is successfully used to treat several types of cancers. Atezolizumab is a potential biosimilar candidate due to its huge success in the clinic but there is no literature on its production process in mammalian cells. In this study, we generated a monoclonal cell line derived from recombinant Chinese hamster ovary DG44 cells to produce atezolizumab. The selected single clone was employed for media screening and process development. Following production in a 7-L bioreactor, atezolizumab was purified using a three-step chromatographic method. Finally, the purified atezolizumab was characterized and compared with commercial atezolizumab (Tecentriq) through several chromatographic and kinetics analyses.</p>","PeriodicalId":9274,"journal":{"name":"Biotechnology and applied biochemistry","volume":" ","pages":""},"PeriodicalIF":3.2000,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Cell line development and bioreactor process optimization for an atezolizumab biosimilar.\",\"authors\":\"Ayca Zeybek Kuyucu, Dogu Sayili, Ridvan Orkut, Olcay Mert, İbrahim Oguzhan Tarman, Busra Lulaci, Ali Mert Sencer, Asli Kurden Pekmezci, Mehmet Ender Avci, Sibel Kalyoncu, Mehmet Inan\",\"doi\":\"10.1002/bab.2704\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Checkpoint inhibitors are widely recognized immunotherapeutic drugs, known for their effectiveness in treating various cancers. Atezolizumab, targeting the immune checkpoint programmed death-ligand 1, is successfully used to treat several types of cancers. Atezolizumab is a potential biosimilar candidate due to its huge success in the clinic but there is no literature on its production process in mammalian cells. In this study, we generated a monoclonal cell line derived from recombinant Chinese hamster ovary DG44 cells to produce atezolizumab. The selected single clone was employed for media screening and process development. Following production in a 7-L bioreactor, atezolizumab was purified using a three-step chromatographic method. Finally, the purified atezolizumab was characterized and compared with commercial atezolizumab (Tecentriq) through several chromatographic and kinetics analyses.</p>\",\"PeriodicalId\":9274,\"journal\":{\"name\":\"Biotechnology and applied biochemistry\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2024-12-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biotechnology and applied biochemistry\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://doi.org/10.1002/bab.2704\",\"RegionNum\":4,\"RegionCategory\":\"生物学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"BIOCHEMISTRY & MOLECULAR BIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biotechnology and applied biochemistry","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1002/bab.2704","RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
Cell line development and bioreactor process optimization for an atezolizumab biosimilar.
Checkpoint inhibitors are widely recognized immunotherapeutic drugs, known for their effectiveness in treating various cancers. Atezolizumab, targeting the immune checkpoint programmed death-ligand 1, is successfully used to treat several types of cancers. Atezolizumab is a potential biosimilar candidate due to its huge success in the clinic but there is no literature on its production process in mammalian cells. In this study, we generated a monoclonal cell line derived from recombinant Chinese hamster ovary DG44 cells to produce atezolizumab. The selected single clone was employed for media screening and process development. Following production in a 7-L bioreactor, atezolizumab was purified using a three-step chromatographic method. Finally, the purified atezolizumab was characterized and compared with commercial atezolizumab (Tecentriq) through several chromatographic and kinetics analyses.
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Published since 1979, Biotechnology and Applied Biochemistry is dedicated to the rapid publication of high quality, significant research at the interface between life sciences and their technological exploitation.
The Editors will consider papers for publication based on their novelty and impact as well as their contribution to the advancement of medical biotechnology and industrial biotechnology, covering cutting-edge research in synthetic biology, systems biology, metabolic engineering, bioengineering, biomaterials, biosensing, and nano-biotechnology.
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