This webcast features: Martin D. Jensen, Senior Engineer, FUJIFILM Diosynth Biotechnologies

Chromatogram review is a monitoring method used to verify process performance in packed-bed chromatography processes. By observing key process parameters such as chromatography column outlet conductivity or UV absorbance, it is possible to identify the signs of a poorly packed column, resin degradation, or equipment malfunction.

The industry standard practice relies on performing a paper-based qualitative visual comparison of chromatography profiles against a reference batch. This approach leads to a time-consuming, resource-intensive process that is prone to mistakes caused by the variability inherent to visual comparison of chromatogram profiles not only in different plots, but also on different sheets of paper.

That process has been reimagined as part of the drive toward Industry 4.0 and the desire to become a digital facility, enabled with systems that can respond to changes in real time and act proactively with the necessary corrective behaviors. With new digital chromatogram dashboards, printing becomes unnecessary, and multiple phases and parameters are reviewed simultaneously, leading to shorter review time. Reliability is increased because the dashboard enables the monitoring of a live batch overlaid on reference batches preselected by a subject matter expert.

This solution is facilitated by implementing the SIMCA® and SIMCA®-online software suites by Sartorius. As a leading contract development and manufacturing organization (CDMO), FUJIFILM Diosynth Biotechnologies strives for increased partner trust and collaboration. Thus, these dashboards (and many others with multivariate models) can be accessed by a partner, providing it with a real-time window to the process.

By digitalizing the existent business process and upskilling the stakeholders to use the tool, resource time expenditure is optimized tenfold (shorter review time, fewer investigations expected), the paper footprint is reduced (~10,000 sheets/year), and data accessibility is made “on demand.” The review process is not hidden and is readily available to different departments.

Key takeaways:

• Chromatogram review is a widely used method for monitoring packed-bed chromatography processes.
• The method usually relies on comparing chromatograms to selected references and is often paper-based and very manual.
• We present an online digital solution that drastically streamlines the qualitative review process.
• Our IT setup as a CDMO allows us to provide our partners with direct and real-time access to their processes.

Watch the recorded webcast now.