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.
Of course, as in most industries, product consistency is key to the success of the Life Sciences industry. With magnetic bead separation, not only should working conditions be constant over time, but conditions should also be consistent from lot to lot, regardless of the time between production runs. One thing that should always be considered is the quality of the magnet used in the biomagnetic separation devices.
Scientists in academic research labs and pharmaceutical labs perform magnetic separation process with magnetic bead kits for immunoassays and separation science. Doctors, lab technicians and scientists use magnetic beads in IVD kits as molecular diagnostics devices.
Those who use Life Sciences products rightly demand that these products show consistency from batch to batch. In other words, when comparing batches, one should find very little, if any, variability.
Last March 4th, Mr. Jordi Andreu Segura defended his paper “Statistical Mechanics of Superparamagnetic Colloidal Dispersions Under Magnetic Fields”, which was submitted to obtain a PhD degree in Materials Science at the Universidad Autónoma de Barcelona.
One of the major problems of traditional magnetic bead separation technology is aggregation of the magnetic beads. Aggregation decreases the yield and also contributes to variability between batches.
Reproducibility is very important when considering production of in vitro diagnostic kits. As such, there should be good quality control in place that strictly defines the parameters of the assay’s raw materials. For example, magnetic beads, antibodies and buffers should not vary from batch to batch. In addition, these raw materials should all act the same during biomagnetic separation.
Often in life science research and clinical applications, magnetic carriers are utilized to separate or isolate biomolecules from suspension. A biomolecule is coated onto a magnetic bead or is ‘captured’ by a bead and then pulled to a given position in the solution via magnetic forces. In order to establish a robust and reproducible standard operating procedure (SOP), one needs to understand how the magnetic forces are generated and what key parameters need to be controlled.
