The cornerstone of any good production process is the ability to have robustness and reproducibility, especially in the biotech industry and in the magnetic bead separation industry.
Since reproducibility over time is a highly desired trait when using biomagnetic separation, especially when used in the life sciences, it is important to consider all possible disruptions of consistency. Biomagnetic separation devices use permanent magnets which maintain their properties over long periods of time.
Biotech companies such as InVitro Diagnostic aim for 100% reproducibility in every single batch they produce and in every kit test in each batch. In fact, customers expect that they will receive a product that will perform exactly the same as the last time they purchased it. It does not matter what batch the product is or when it was produced.
It is vitally important for life sciences products to be consistent from lot to lot, so two batches of the same product produced in the same way should have little variability. In order to achieve a high level of quality control, one must define a strict standard operating procedure (SOP). In the case of a permanent magnet magnetic bead separation device, conditions are usually very stable and so the main parameter to control is the time the vessel is exposed to the magnetic field during production.
There are no easy ways to bypass steps or simplify the production process of magnetic bead separation. Steps in the production process that seem easy or easily bypassed, turn the production into a nightmare if one attempts to take short cuts. One of these seemingly easy steps is the resuspension step.
During the development of a magnetic bead separation process, scientists put great effort into reproducing the size of the beads, the magnetic charge on the beads, buffer composition, pH and temperature. What is often overlooked, however, is the importance of homogeneous biomagnetic separation conditions.
Separation techniques using magnetic carriers (either beads or particles) are often used in the life sciences to ‘capture’ specific biomolecules. These techniques utilize immunocapture, DNA fragments, or electrical charge in order to specifically target the biomolecule of choice. After magnetic capture of the biomolecule, magnetic forces can separate it from the rest of the milieu. Because of the seeming ease of separation, biomagnetic techniques are used by some as the ‘gold standard’ of separation technology.
Biomagnetic separation technology is being widely adopted in many biotech and other life science industries. The managers of these industries spend a lot of energy, time and resources choosing the correct beads for their applications, however they often overlook very important variables that need to be controlled pertaining to the magnetic bead separation process.
In Vitro Diagnostic (IVD) Immunoassays are some of the most successful life science magnetic bead and particle research applications that have come to market. The demand for such technology in hospitals and laboratories in particular, has grown dramatically.
It is common knowledge that industries and biotech companies must validate any production process in order to maintain the consistency of their products. In processes that cannot be validated at a high level, lot numbers become very important so that the end user can compare and understand lot to lot variation.