Cell line development and bioreactor process optimization for an atezolizumab biosimilar
Biotechnology and Applied Biochemistry, vol.72, no.4, pp.897-910, 2025 (SCI-Expanded, Scopus)
- Publication Type: Article / Article
- Volume: 72 Issue: 4
- Publication Date: 2025
- Doi Number: 10.1002/bab.2704
- Journal Name: Biotechnology and Applied Biochemistry
- Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Applied Science & Technology Source, BIOSIS, Biotechnology Research Abstracts, CAB Abstracts, Chemical Abstracts Core, Compendex, Computer & Applied Sciences, EMBASE, Environment Index, Food Science & Technology Abstracts, INSPEC, MEDLINE, Veterinary Science Database
- Page Numbers: pp.897-910
- Keywords: atezolizumab, bioprocess engineering, biosimilar, cancer, monoclonal antibody
- Dokuz Eylül University Affiliated: Yes
Abstract
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.