Magnetic separation is a breakthrough technique for in vitro diagnostics (IVD). Scientists, hospitals and companies have taken advantage of the magnetic separation process for immunoassays, molecular diagnostic and genetic testing systems and kits. However, this type of technology is typically utilized by the end-user in very small quantities.
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:
Why do lot inconsistencies keep happening?
When scaling up production processes, if one simply uses larger magnets or classical magnetic separators, the process will inevitably lead to in-lot inconsistencies, high material losses of both beads and biomolecules, aggregation of the beads and safety issues. In fact, accidents from a lack of attention to safety issues have been reported and are not rare.
Unless one uses homogenous biomagnetic separation conditions from the very earliest developmental steps, the cumulative experience will be useless when volumes are scaled up. The information will not translate to larger volume production processes. In addition, if you do not know all of your conditions, you cannot use the same principles and biomagnetic separation techniques that you have been using in the lab when you go to production.
Therefore, production managers should take care to know all of the conditions product developers are using – not just the separation time variable for one specific device. To go to production, you must know all of the experimental conditions you rely on in the lab. If all you have monitored is separation time, it will not be enough information to allow those who need to scale up production to do so.
Our guide to validate biomagnetic separation processes explains how the production process involving magnetic beads can be smoothly and efficiently scaled up using homogenous biomagnetic separation systems such as SEPMAG, as opposed to using classic magnetic separators or simple magnets.
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
- Centrifugation and Filtering with Biomagnetic Separation
- How to Guarantee Lot-to-Lot Consistency in Biomagnetic Separation