Because biomaterial is expensive, fragile, complex and sometimes rare, biotech companies spend a great deal of time and resources to develop and refine biomaterial production processes. Quality control and standard operating procedure demand that production managers make sure that all technicians and operators know and follow the exact procedures from batch to batch.
Typically, the parameters of a process are painstakingly determined before production can proceed in a scaled-up manner. The exception to this seems to be in the case of magnetic bead separation processes.
This post is about magnetic bead separation and how to validate this process. If you are interested in this topic, and are willing to learn more about it, download our Free Guide The Starting Guide to Validate Biomagnetic Separation Processes:
Traditional vs advanced magnetic bead separation
When companies use traditional magnetic separators without fully understanding the critical aspects of separation, they are unable to understand the end product results and are unable to control the consistency of the process. Too often magnetic separation is not consistent or reproducible.
It is important for production managers to understand that in traditional magnetic separation, not all beads are exposed to the same conditions. The beads close to the magnet experience very strong magnetic forces for a long period of time. These beads will likely have issues with aggregation, loss of activity and resuspension difficulties. The beads far away from the magnet experience variable magnetic forces or weak magnetic forces. Because of the variation in force as the beads travel closer to the magnets, the properties of the beads will be affected.
Sepmag biomagnetic separators are advanced systems that create homogenous and well-defined magnetic forces independent of the distance from the magnets. All beads ‘see’ the same magnetic force in these systems. Because of this, the process is highly reproducible and easily scalable.
Included with the Sepmag separators is a Quality Control Recording device that monitors the process in real time, allowing the production manager to keep track of performance for regulatory and quality control purposes. The recording device is an optical recorder that detects the turbidity of the liquid and comes with software for full analysis of the data in real time. The software supplied will run on any PC.
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