A monoclonal antibody process was enhanced to increase manufacturing flexibility and ensure product supply. Development efforts achieved an increase of over 1.5 fold in yield. However, obtaining comparable product quality proved to be technically challenging. This presentation will focus on efforts to better understand how to control heterogeneity in product quality while increasing titers. Cell culture process parameters, media feed compositions and regimes were varied to investigate the impact on various product quality attributes. For high titer conditions, these experiments revealed significant differences in glycosylation and acidic species, despite similar growth. Challenges encountered during development, as well as strategies that helped resolve them will be discussed. Comparable product quality profiles were achieved for this high titer process.

Achieving comparable product quality profiles through cell culture process and media optimization

249th National Meeting (2015)

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