When using biomagnetic separation, in order to ensure the consistency of the resulting product and the process itself, there must be some sort of validation procedure. Validation should be consistent within a given lot, from lot to lot and also when the process is scaled up. The validation procedure should optimally be related to the conditions of magnetic bead separation and not be dependent on any specific device that generates the magnetic field.
Lluis M. Martínez, SEPMAG Chief Scientific Officer
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One of the biggest problems of producing magnetic beads when scaling up the production is that compared with smaller lot production, larger lot production seems to result in a much larger disproportionate loss of beads. This seems to happen even when the beads are produced in conditions that are similar to the small lot production in a magnetic separation process. The assumption is that when you scale up a process, you will have greater efficiency, but this does not happen when scaling up production of magnetic beads using classical separators.
Biomagnetic separation used to take place in academic labs, but recently it has become a very industrial application. As processes are scaled up and volumes increase, the investment required for each batch is larger, but the expected economic return is also larger.
It is understandably important to end users that every kit within a particular lot have the same properties. In other words, when one is producing lots of material to be used in an IVD kit, one necessarily strives for maximum reproducibility and minimal variability. With standard magnetic separators, it is very difficult to achieve this goal in a magnetic separation process.
Because biomagnetic separation techniques are relatively simple, life science laboratories and industries are quite enamored with them. Indeed, using only magnetic beads and magnetic fields, biomolecules can be captured and extracted from complex media in magnetic bead separation. However, if this application is to be considered practical, it should also be faster than other separation technologies such as chromatography, electrophoresis or centrifugation.
By Lluis M. Martinez, CSO Sepmag
Often when a lab produces a product that becomes popular, the impetus is to move forward and scale up production of that product. The problem is that moving from the production of small lots to full scale production usually produces surprising results. Scaling up is not trivial, and the magnetic separation process is no exception. When one scales up production, results become very inconsistent.
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.
What are the problems of the classic magnetic separation process? Typically the classic ways to produce magnetic bead reagents and kits are slow, very high maintenance and costly to run. The three classic techniques, centrifugation, filtration and tangential filtration, are not straightforward techniques.
Consistent lot-to-lot results are achieved with biomagnetic technology only when magnetic bead separation is performed in defined and homogeneous conditions. When homogeneity is realized, separation is reproducible and scalable.
