Boosting Productivity for Advanced Biomanufacturing by Re-Using Viable Cells.

Area of Science:

• Biotechnology
• Biopharmaceutical Manufacturing
• Process Intensification

Background:

• Monoclonal antibodies (mAbs) are crucial therapeutics, but high manufacturing costs remain a challenge.
• Process intensification strategies, including fed-batch and perfusion, aim to improve efficiency.
• Opportunities exist to further reduce antibody production costs.

Purpose of the Study:

• To demonstrate the feasibility and benefits of a novel hybrid process combining fed-batch and fluidized bed centrifugation (FBC) for mAb production.
• To investigate and optimize process parameters for enhanced cell proliferation and viability.
• To compare the hybrid process against standard fed-batch operations at a 5-L scale.

Main Methods:

• Utilized a fluidized bed centrifuge (FBC) for complete media exchange in a hybrid process.
• Conducted small-scale FBC-mimic screening to optimize process parameters.
• Scaled up the optimized hybrid process to 5-L and compared it with a standard fed-batch process.

Main Results:

• The hybrid process achieved a 163% increase in peak cell densities compared to standard fed-batch.
• Demonstrated a 254% increase in monoclonal antibody (mAb) yield within the same reactor size and process duration.
• Maintained comparable critical quality attributes (CQAs) and showed potential for scale-up.

Conclusions:

• The novel hybrid process, integrating fed-batch robustness with FBC media exchange, significantly enhances mAb production efficiency.
• This process intensification strategy offers a viable and cost-effective alternative for industrial biopharmaceutical manufacturing.
• The approach shows strong potential for future large-scale implementation with minimal additional monitoring requirements.