Cell culture process characterization conducted during late phase process development of biopharmaceuticals is an extremely critical but time consuming and labor-intensive stage. Traditionally, bench scale bioreactor systems have been used for scale-down model qualification (SDMQ) for this purpose. High-throughput mini bioreactor system such as ambr250 bioreactors can significantly improve the time and effort required to conduct process characterization studies. Here, we describe the approach taken to qualify ambr250 as a scale-down model of a GMP scale manufacturing cell culture process to produce a monoclonal antibody. The seed train was conducted using shake flasks and wave bioreactors up to the N-2 stage. Ambr250 system was used to establish a scale-down model for the N-1 seed stage and the production (N) stage. It was found that the cell growth, viability, nutrient/metabolite and titer profiles generated using ambr250 bioreactors were found to be comparable to the pilot and the GMP scale process. Product quality attributes such as size exclusion chromatography (SEC) profile, non- reduced and reduced capillary electrophoresis (NR/R CE) profile, charge heterogeneity using ion exchange chromatography (IEX), N-glycan and residual DNA (rDNA) were also found to be comparable. The results indicated that ambr250 bioreactor system can be successfully used for scale-down model qualification of N-1 and N stage of cell culture process and the subsequent process characterization studies.

Scale-down model qualification using ambr250 high-throughput bioreactor system for process characterization

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.