Miniaturized Bioprocessing Tools to Advance Biopharmaceutical Production

Reducing the biomanufacturing cost, time to market, and developing adaptable processes for different biologics and modalities are the main drivers in advancing biopharmaceutical production. Automated high throughput screening tools at smaller volume with scalable processes to large scale production are effective means to improve the biopharmaceutical production.

Sartorius has initiated a workstream to focus on miniaturized tools for various biomanufacturing phases; drug discovery, cell line development, and bioprocess optimization that are adaptable for different modalities.

Small volume (pL-µL) miniaturized bioreactors enable single-cell analysis, decrease the sample and reagent consumption, reduce the time required until enough detectable protein is secreted, and hence enable more efficient experiments at lower overall cost. The automated high throughput single-cell analysis can significantly reduce the cell line development timeline and early discovery assays for different modalities such as mAb and cell therapy.

Early bioprocess optimization at smaller volumes with an in-depth understanding of the bioprocesses enables rapid and robust development with the right-first-time R&D approach. Our research also covers miniaturized bioreactors for bioprocess optimization to obtain a large dataset relevant for the production scale with process variables (e.g. pH, oxygen, cell density), physiological and metabolic data, and drug product attributes. One of the main challenges is integrating PAT tools due to the space constraints within these miniaturized bioreactors to monitor both process parameters as well as product quality attributes. Another task is to develop a translational tool to be scaled up to large scale production bioreactors. We also focus on developing downstream processing tools to provide a continuous autonomous bioprocessing tool that can be used for prediction and simulation.