October 25, 2024
Sponsored by Repligen
A significant challenge for TFF operators is an overreliance on vessel concentration estimates and upfront calculations, instead of real-time concentration data. In an attempt to maintain accuracies, operators frequently need to retrieve offline samples throughout the process to conduct analysis. If the feed solution is over concentrated, dilution would be required and possibly a rerun of the process. If below concentration targets, processing times would have to be extended. These cumbersome steps severely drive down process efficiency and increase the risk of batch-to-batch variation. In response to these challenges, Repligen has developed a line of innovative TFF systems that empower users with unparalleled process control and optimization- The KrosFlo® RS RPM™.
To evaluate the capabilities of the KrosFlo RS RPM against conventional TFF systems, this application note examines the outcome of an ultrafiltration/diafiltration (UF/DF) process using bovine serum albumin (BSA). Examining the data sets generated from estimated volume concentration factor (VCF), off-line sampling, and the in-line concentration measurement of the system, the KrosFlo RS RPM demonstrated a 30% increase in concentration accuracy.
Key takeaways:
KrosFlo RS RPM systems give operators precise process control with real-time concentration data generated in-line.
KrosFlo RS RPM systems leverage in-line concentration measurements to automate processes and adapt for variability while limiting offline sampling and dilution.
In-line concentration data generated by Process Analytics Technology (PAT) driven cGMP TTF systems can increase accuracies by over 30% as compared to upfront calculations or vessel weight measurements.
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