Protein titer data is a critical during process development and manufacturing of protein-based biopharmaceuticals. Speed and accuracy of this data is key in instituting a process analytical technology (PAT) approach, as this allows for monitoring critical process parameters (CPP) and informs real-time decision making. In addition, this type of data when collected during process development enables optimization of cell culture conditions, protein yield, bioreactor run length and harvest time. Collecting this data during a bioreactor run is ideal, but can be time consuming and resource intensive with traditional tools.

IDEX Health & Science recently launched the compact Tridex™ Protein Analyzer to provide a purpose built tool to meet the need for fast, simple protein titer data collection. The Tridex is capable of manual sampling or automated sampling. When coupled with an automated sampling system, it can generate rapid at-line measurement of antibody titers during bioreactor runs using an aseptic sampling device. The system employs a proprietary trap-and-elute technique to quantify the amount of IgG in a cell-free sample. It is able to effectively monitor product yields throughout a bioreactor run by employing a wide dynamic range of 0.1 – 10 g/L. This process delivers fast and accurate results in minutes without the need for method development or specialized training.

Easy to Use

Tridex is designed to integrate directly into a bioprocessing suite without disrupting existing workflows or equipment. Key to implementation of any new process into an existing workflow, the Tridex was designed for easy start up with minimal connections. For example, the reagent pack and analysis modules easily lock into place without any additional tools.

Once up and running, the only maintenance is to change the plug and play consumables regularly. The consumable packs are designed to last for 1,000 injections. Users are able to take measurements in the range of 0.1 to 10 g/L without sample dilution or recalibration. No chromatography experience is required.

The computer screen interface is intuitive and interactive with four main screens to view data and take measurements.

Measurements are obtained using a four-step process

1. Users select a calibration curve and enter sample information using the interface.
2. The sample is loaded through the injection port
3. Users press “run sample” using the interface to start analysis
4. Titer results are automatically displayed on integrated monitor in under 5 minutes.

Flexible

The Tridex system is flexible and permits manual or automated sampling. When used with an automated sampling system, measurements are obtained with a few clicks on the interface. This permits real-time data collection and decision-making. In addition, the compact design and small footprint allows for easy incorporation into existing workspaces. Tridex is designed to be used in a manufacturing environment but can function equally well in a laboratory.

Accurate

Presented data demonstrates the comparability of titer measurements for the Tridex to HPLC both at-line and off-line (Figure 1). Antibody titer at each level was calculated using the average three measurements for all data sets. Accurate at-line and off-line titer measurements up to 6.5 g/L were obtained using the Tridex analyzer without sample dilution using linear calibration curves (Figure 2).

For more information, please see Tridex Analyzer

Please contact IDEX for a demo, or to see when the Tridex will be in your area.