A Mab A Case Study In Bioprocess Development Jun 2026

: The study only considers a subset of quality attributes for simplicity; in a real-world scenario, the analysis would be significantly more complex.

: Continuous manufacturing technologies are also transforming DSP. A case study published in Biotechnology and Bioengineering investigated the use of a novel convective diffusive protein A membrane adsorber (MA) in two different continuous multi-column chromatography (MCC) processes: rapid cycling parallel multi-column chromatography (RC-PMCC) and rapid cycling simulated moving bed (RC-BioSMB). Both processes achieved a product yield of approximately 90% over four days of continuous operation. Productivity was impressively high, reaching 1010 g/L/day for the RC-PMCC process and 574 g/L/day for the RC-BioSMB process, while maintaining high removal of process-related impurities. A complementary study on a different mAb found that implementing a multi-column capture process reduced operation costs by 18% and nearly doubled productivity compared to the conventional single-column batch process. A Mab A Case Study In Bioprocess Development

Even after Protein A, impurities remain. We implemented a two-step polishing phase: : The study only considers a subset of

Scalability was evaluated sequentially from 250 mL ambr® micro-bioreactors to 5 L benchtop systems, and finally to a 2,000 L single-use bioreactor (SUB). Both processes achieved a product yield of approximately

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At the 10,000 L scale, the impeller tip speed is higher than in pilot reactors. Initial runs show 15% lower viability at harvest. The solution is to reduce the agitation rate from 180 rpm to 120 rpm and switch to a marine impeller (rather than Rushton turbines), which provides adequate mixing with lower shear. Dissolved oxygen is maintained via larger sparger rings.