End product variability is caused in large part by resuspension problems in your process. During a magnetic separation process, the retention forces in the system need to be high enough that losses of the beads will be avoided when the buffer is pumped out. But the forces should not be too great because if they are excessive, beads will aggregate.
Aggregated beads are tightly associated with each other, precluding the functionalization of part of their surface area with biomolecules such as antibodies, antigens or genetic material. Optimizing the retention forces (e.g. in homogeneous biomagnetic separation) and performing resuspension steps can help reduce the risk of aggregation.
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However, waiting until the very end to check the performance of the process implies that one will not be able to detect any problems until days or hours after the start of the batch. If this happens, you cannot take corrective actions or start a new batch if the problems are too severe.
Solving the problem with homogeneous biomagnetic separation techniques
With homogeneous biomagnetic separation techniques, one can monitor the process, allowing one to detect aggregation problems during the process. Clusters of aggregated beads behave in suspension as beads with a greater diameter and would move much quicker than expected. If you are including several washes, aggregation will increase with each step. Therefore, the monitor can detect that the aggregates move more quickly with each successive step in the process.
If you can detect aggregation early in the process, you would be able to take immediate corrective action by stopping the process and adjusting the settings or by discarding the lot in progress and starting a brand new lot. This decision depends on the policy of your company and how far along the beads are in the production process. Monitoring is an important part of saving the company time, effort and money in this way.
If you found this post about using biomagnetic separation for production useful, don't forget to check these related posts:
- Perfecting the magnetic separation process in magnetic bead IVD kit production
- Monitoring with Homogenous Biomagnetic Separation to detect QC Issues
- The Safe Use of Biomagnetic Separation Systems in Production Facilities