By Markus Schulze, Marco Leupold, Ute Husemann, and Jens Rupprecht, Sartorius Stedim Biotech GmbH
Single-use tools offer a variety of benefits for biopharmaceutical processes. However, their widespread and successful implementation requires that they perform comparably to established, multi-use systems.
Novel modalities (such as mRNA therapeutics) mean microbial systems are increasingly employed in modern biopharmaceutical processes. Microbial culture comes with its own operational challenges due to the high cell density at which cells are grown. Therefore, before implementing single-use technologies, it is essential to confirm that these systems can handle the increased demands.
In this application note, we test the capabilities and robustness of the new single-use fermenter Biostat STR® Microbial in a fast, exponentially growing, high cell density Escherichia coli (E. coli) process.