Biosimilars are a growing interest in the biopharma industry as they provide affordable alternatives, shorter regulatory path and due to the near-term patent expiry on several blockbuster biologics. However, biosimilar process development is challenging as it requires comparable product quality and efficacy to the innovator, which is established by matching physiochemical properties. We have established a toolbox to regulate product quality for biosimilars through upstream process development. Two case studies demonstrating use of the toolbox will be presented. In the first case study, differences in charge variant distribution were observed due to cell line expression systems (CHO vs NS0). Media and feed screening experiments and process parameter optimization were conducted to achieve a 3-fold increase in acidic charge variants to match with the innovator product quality profile. In the second case study, lower ADCC activity was observed due to lower levels of high mannose species. A screening study was used to investigate the impact of several factors including feed supplement, osmolality, and pH to modulate N-glycan profiles, particularly mannose species. Results from the study showcasing at least 2-fold increase in mannose levels and consequent improvements in ADCC levels will be discussed.

Defeating product quality challenges for biosimilars through cell culture process development

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.