QbD and PAT regulatory initiatives aim to achieve consistent production of product having predefined quality and demand numerous process development studies to establish design space for each product quality attribute. Novel high-throughput minibioreactors have a great potential to fulfill this demand. However, their comparability with conventional bench scale systems needs to be established. Comparability studies of high-throughput minibioreactors versus 5L bioreactors focusing on gene profiling have been discussed in the past. Yet, protein titer and quality aspect has not been dealt with. Here, we further investigate the comparability by looking into titers and N-glycan profiles of monoclonal antibody produced by serum free mammalian cell culture. We use a two-step scheme to purify IgG3 antibody from the cell culture broth and carry out N-glycan analysis using high pH anion exchange chromatography with pulsed amperometric detection. Influence of pCO2 in minibioreactors and bench scale systems is also discussed.

Comparability of monoclonal antibody titers and its glycosylation profile produced in minibioreactors vs. bench scale bioreactors

243rd National Meeting (2012)

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