When a biotech company or other related industry decides to use biomagnetic separation technology, a great deal of time, energy and resources are typically spent by R&D and manufacturing departments to determine the optimal bead to use for their specific applications. Often, however, they overlook one of the major determinants of separation: homogeneity of separation conditions.
Magnetic beads are used by many biotech companies, typically for in vitro diagnostic applications and magnetic bead separation. Because these beads are so widely used, it is very important that every aliquot of every batch has exactly the same properties.
Traditional biomagnetic separation techniques have several drawbacks that affect both the quality and the quantity of the final product.
Biomagnetic separation needs validation in order to ensure reproducibility. The skills necessary to identify the key parameters affecting separation performance, measure those parameters, and enact the appropriate controls are specific and require an excellent background in physics.
Magnetic bead separation is being used in more and more applications (e.g. immunoassays, collection of genetic material, protein purification). Most of these applications are industrialized and therefore require quality control protocols, validation audits and standard operating procedures. Because of the economic implications, production mistakes are not acceptable, so products must demonstrate reproducibility in order to be viable.
The success of magnetic bead separation technology comes from its simplicity. Magnetic beads capture biomolecules and then they are extracted from the suspension. No filters are needed, there are no disposables, and there are no moving parts.
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.
