An automated bioreactor sampling solution for assuring on-line PAT analytical fidelity

In the current bioprocessing environment a significant unmet need still exists for precise, automated, real-time analysis of important culture process parameters such as nutrients, metabolites and various cell measurements. Transforming these traditional off-line analytical methods into an effective, automated, on-line process analytical technology (PAT) platform requires certain criteria to be met.  At a minimum, an automated sampling system should (1) not compromise the bioreactor’s sterile environment; (2) establish connectivity of process systems; (3) facilitate a scale-independent strategy; (4) seamlessly integrate the real-time data into the process management system and (5) provide rapid and precise analysis that performs as good as or better than the manual off-line analytical method.  A Seg-Flow® automated on-line sampling system, which meets the aforementioned criteria, was evaluated for its ability to preserve the analytical integrity of various integrated 3^rd party analyzers typically used for culture process monitoring.  The performance evaluation encompassed a broad range of analytes and measurement ranges, while comparing automated on-line analysis with the analyzer’s respective manual, off-line analytical method.  In short, the analytical fidelity of each Seg-Flow-integrated analyzer was preserved and demonstrated a reliable, automated on-line PAT solution for bioreactor culture monitoring and control.