Getting accurate “QC grade” in-line concentration measurements can be difficult for a variety of reasons.
Our newest in-line VPT Solution for “GMP grade” manufacturing. CTech™ FlowVPX® System delivers high quality and highly reproducible results — enabling increased process understanding, improved cycle time, and reduction in process control testing efforts.
Here are just a few of the applications that demonstrate the reliability and performance of the FlowVPE System.
The graph below shows a chromatogram from the FlowVPE used to measure the mass loading on a column and the mass eluting off a column. It also tracks the breakthrough of the protein from the column.
FlowVPE is able to measure titer, loading mass and elution mass in real time, making it easy to calculate recovery percentage. As demonstrated below, the difference between the FlowVPE concentration pre- and post-column equals the harvest titer.
KBI Biopharma has had success using the FlowVPE System in dynamic binding capacity studies. The FlowVPE is extremely accurate at high concentration which means you can achieve a good reading on the breakthrough.
In UF/DF, the FlowVPE System allows you to measure real time concentration, eliminating the need for off-line sampling and ensuring accurate completion of your final concentration to adequately achieve your ideal drug concentration.
In this study, we took samples out every few minutes, measured them via A280 with a gravimetric dilution and compared the results to the FlowVPE concentration signal.
| Sample mAB | FlowVPE (mg/mL) | Gravimetric (mg/mL) | %Difference |
|---|---|---|---|
| 1 | 14.6 | 14.6 | 0.4% |
| 2 | 53.2 | 55.0 | 3.4% |
| 3 | 60.4 | 62.6 | 3.7% |
| 4 | 67.4 | 69.7 | 3.4% |
| 5 | 109.9 | 110.9 | 0.9% |
| 6 | 160.1 | 155.1 | 3.2% |
| 7 | 213.0 | 212.1 | 0.4% |
| 8 | 238.9 | 239.0 | 0.0% |
During the dilution step the FlowVPE/X can be used to monitor the concentration and ensure the product hits the target prior to filling.
The FlowVPE/X is put in a recirculation loop during the process and can monitor throughout so that the risk of over dilution is avoided.
CTech is committed to our customers’ success. We design service offerings to supplement our standard support options and provide you with increased access to our highly knowledgeable and experienced professionals. We offer implementation, development, and educational guidance to maximize the benefits of your variable pathlength solutions and the Slope Spectroscopy® technique.
Connect with our dedicated applications team. Our team can show you how to maximize the benefits of your variable pathlength solutions and the Slope Spectroscopy® technique. Let us help you expedite your SoloVPE Validation.
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