Cell line development and bioreactor process optimization for an atezolizumab biosimilar

Ayca Zeybek Kuyucu1, Dogu Sayili1, Ridvan Orkut1

  • 1Izmir Biomedicine and Genome Center, Izmir, Turkey.

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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