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.
This post is about biomagnetic separation in the production of magnetic beads for IVD kits. If you want to know its most important elements, download our free ebook The basic guide to use biomagnetic separation in production processes:
Magnetic beads for the magnetic separation process
A company that produces magnetic beads-based products starts with the raw materials, namely, magnetic beads and antibodies (or other biological material). They incubate the two together and create a bead with an attached functional biological molecule. This is called functionalizing the beads. Once the beads are functionalized, they are then separated from the supernatant, wash the beads and then aliquot the functional beads into doses. These doses will be placed in individual IVD kits and sold to researchers, hospitals and other biotech institutions.
The key aim of any production process is consistency. One does not want variability within a kit or between kits from a particular batch or even variability between batches if that is achievable. Normally most processing methods in the past used the classic techniques of centrifugation, filtration and/or tangential filtration. But these techniques are quite slow.
For example, centrifugation takes time and material is lost in the filtrate; filters can clog; filters can change their performance over time and these pieces of equipment need a lot of care and maintenance to keep them running in good condition. Filtration methods require the operator to set the flow, the temperature, the pressure, the warm up time, and clean the filters regularly.
The importance of validating the magnetic separation process
While the above mentioned classical techniques are the only ways to separate beads from a solution when the beads are not magnetic, biomagnetic separation wisely takes advantage of the properties of magnetic beads to more quickly and cleanly achieve separation. In addition, biomagnetic separation operates with minimal maintenance and very low costs. Even so, this technique is not guaranteed to give one consistent results unless one diligently validates the process and ensures that the parameters for the process are well established. This will be further explained, but in brief, homogeneous conditions that are well-controlled will provide consistent results from lot to lot and within a particular lot.
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
- The Set up of Biomagnetic Separation Production Processes
- Common mistakes that lead to inconsistency