APPLICATIONS
Monitor UF/DF at-line in near real time
Track protein and buffer component concentrations in retentate samples over time
Ultrafiltration (UF) and diafiltration (DF) are used in downstream processing to concentrate proteins and exchange the surrounding buffer into a solution that is suitable for the next purification step.
CLADE™ technologies support at-line UF/DF monitoring by providing quantitative data on protein and buffer component concentrations from pulled samples in minutes. This can help teams adjust process parameters during development or process optimisation.
Optimise your UF/DF process with near real-time monitoring
CLADE™ analytical tools combine mid-infrared FTIR spectroscopy and chemometric data analytics to provide rapid insights into UF/DF sample composition, enabling at-line monitoring.
Use UF/DF monitoring to reduce low-quality batch risk
UF and DF are membrane-based separation processes used in pharmaceutical manufacturing to concentrate and purify monoclonal antibodies (mAbs), recombinant proteins, and other biologics.
If UF/DF monitoring methods do not provide timely component quantification, teams may struggle to optimise buffer exchange efficiency during the process and maintain product quality consistency.
Quantification of buffer components and API concentration during UF/DF provides insights for process control. It can help teams adjust parameters sooner and reduce the risk of aggregation or other factors that may affect the final formulation.
Use case: Track buffer exchange efficiency throughout the UF/DF process
In mAb manufacturing, UF/DF is a vital step to concentrate the product and exchange it into the desired formulation buffer. Monitoring this step supports process understanding and helps teams confirm that the final drug substance meets its target quality attributes.
In this example, UF/DF samples were taken at five different time points to monitor sample composition over time using CLADE™ MIRA Analyzer. The overlaid FTIR spectra showed different chemical fingerprints of samples at different time points throughout the UF/DF process (T0 – T4, Figure 1).
Figure 1. Example of normalised spectral data obtained from the CLADE™ MIRA Analyzer, showing different chemical fingerprints of samples taken at different time points throughout the UF/DF process.
This spectral data can be evaluated with CLADE™ analytics to obtain quantitative values for protein and buffer component concentrations. As selected quality attributes can be measured within minutes, this approach supports timely parameter adjustments during process development.
Use case: Monitoring of Polysorbate 80 accumulation in a UF/DF process
In this example, we monitored a UF/DF process for a formulation containing the surfactant Polysorbate 80 (PS80) as one of the excipients. Samples were measured with the CLADE™ MIRA Analyzer and evaluated with CLADE™ data analytics tools.
The results showed PS80 accumulation in the retentate over time. As CLADE™ technologies deliver results in 4 minutes, this trend was detected in near real time.
Figure 2. Monitoring of a UF/DF process for a formulation containing Polysorbate 80 (PS80) as an excipient. Samples were taken at 12 time points during the process. The red vertical line highlights the end of DF.
The near-real-time view of protein and excipient concentrations enabled by the CLADE™ MIRA Analyzer and CLADE™ data analytics tools can help identify process deviations that may affect final drug product quality.
Explore more applications for more efficient bioanalytical workflows
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