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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.

Biotechnology and Applied Biochemistry
|December 3, 2024
PubMed
Summary

This study details the development of a Chinese hamster ovary cell line for producing atezolizumab, a cancer immunotherapy. The process involved cell line generation, bioreactor production, and purification, yielding a candidate for biosimilar development.

Keywords:
atezolizumabbioprocess engineeringbiosimilarcancermonoclonal antibody

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Area of Science:

  • Biotechnology and Biopharmaceutical Manufacturing
  • Cancer Immunotherapy
  • Mammalian Cell Culture

Background:

  • Checkpoint inhibitors, such as atezolizumab, are crucial immunotherapies for various cancers.
  • Atezolizumab targets the programmed death-ligand 1 (PD-L1) immune checkpoint.
  • Despite clinical success, the mammalian cell production process for atezolizumab remains undocumented, hindering biosimilar development.

Purpose of the Study:

  • To establish a robust mammalian cell line for atezolizumab production.
  • To develop and optimize a scalable manufacturing process for atezolizumab.
  • To characterize the produced atezolizumab and compare it with the commercial product.

Main Methods:

  • Generation of a monoclonal cell line from recombinant Chinese hamster ovary (CHO) DG44 cells.
  • Media screening and process development for atezolizumab production in a 7-L bioreactor.
  • Three-step chromatographic purification and subsequent characterization of the purified antibody.

Main Results:

  • A stable monoclonal cell line capable of producing atezolizumab was successfully generated.
  • Optimized media and bioreactor conditions facilitated efficient atezolizumab production.
  • Purified atezolizumab exhibited comparable characteristics to the commercial reference product (Tecentriq) via chromatographic and kinetic analyses.

Conclusions:

  • This study presents the first report on the mammalian cell-based production process for atezolizumab.
  • The developed process yields a high-quality atezolizumab product suitable for further evaluation as a biosimilar.
  • This work provides a foundation for the scalable manufacturing of atezolizumab and potentially other antibody-based immunotherapies.