When a new CLIA-IVD kit is transferred from R&D to production, all the manufacturing protocols should be adapted to the new throughput and volume. Biomarker specifications, buffers and coating protocols would benefit from the cumulated experience in non-magnetic kits. Coupling an antibody to magnetic beads is quite similar to doing it in colloidal gold or latex particles. But the washing protocols using Biomagnetic Separation are something new. The use of classical (and dirty) centrifugation method makes not so much sense when we can use the magnetic properties of the beads. Similar reasoning applies to the use lateral flow filtration or other complex and time-consuming non-magnetic separation techniques.
The most frequent concern when considering the use of modern Biomagnetic Separation Systems is their compatibility with specific magnetic beads. Although Sepmag® devices are already working successfully in IVD labs and production lines, this is a very legitimate question.
Learning more about the behavior of magnetic beads separation when strong magnetic fields are applied
When one scales up production using a classic magnetic separation system, one finds that the separation time increases quickly with an increase in production volume. An increase in separation time means that material losses are higher and aggregation problems become a serious problem. By using homogenous separation time, one finds that the magnetic separation process is shorter and the separation time can be easily estimated. In homogeneous systems material loss and bead aggregation is minimized.
Magnetic beads need to be constantly mixed and homogenized to avoid sedimentation and clumping problems. Even when the sonication method is necessary to break up aggregates, mixing and homogenization is necessary.
In the Life Sciences, one of the most critical parameters for final IVD kit performance is magnetic bead concentration. The beads are functionalized before the magnetic separation process with antibodies or other biological molecules, so the concentration of magnetic beads also delivers a specific concentration of biologically active reagent. If you do not have the correct amount of beads/biological molecules in your preparation, the sensitivity of the kit changes significantly. Therefore volume control of the suspension is quite important.
In non-homogenous magnetic separators, monitoring the entire separation process is difficult to impossible. As a result, errors in the magnetic separation process, such as using the wrong magnetic beads or using buffers with the wrong properties are not detected until the final QC testing stage.
When magnetic bead reagents are produced in quantity, often you cannot know if you have the correct properties of the beads until the final quality control step. But if these properties are wrong, finding out the properties at the end of the magnetic separation process for production does not allow you to salvage the lot. Knowing magnetic bead properties, such as size, magnetic charge and surface charge, is critical in order to have excellent reproducibility in the final product (e.g. IVD kits).
Classic magnetic separation equipment requires a large amount of space in order to comply with health and safety regulations. While the magnetic separation process has numerous advantages, the magnetic fields surrounding the devices may be so large that they fall within the ‘danger’ and/or ‘caution’ areas.