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.
Customers expect that variation from batch to batch will be nonexistent. Therefore, it is incumbent on the company to make sure that there is consistency not only between lots over time but also within the same lots.
This post is about magnetic bead separation and how to validate this process. If you are interested in this topic, and are willing to learn more about it, download our Free Guide The Starting Guide to Validate Biomagnetic Separation Processes:
Lot consistency in magnetic bead separation
Traditional magnetic separation does not always deliver this level of consistency because if traditional magnetic separators are used, not all beads experience the same conditions. Beads closer to the magnet experience b magnetic forces over a long period of time and are fully magnetized. On the other hand, beads far from the magnet experience weak magnetic forces and variable magnetization. Weak forces cause magnetic beads to be lost during the process because they are not separated out with the other material.
In addition, variable magnetization can affect the property of the beads , i.e. the magnetic force of the beads themselves. b forces over too long a period of time can lead to aggregation of the beads, loss of bead activity and resuspension problems. All of these things can be translated into lot to lot variation and inconsistencies.
As long as one performs separation using defined and homogeneous conditions that have been shown to be reproducible over time and scalable to any volume, modern biomagnetic separation techniques will be functionally consistent.
The latest developments in biomagnetic separation technology consist of separators that create a homogeneous and well defined magnetic force no matter how far away the bead is from the magnetic source. Therefore, all beads experience the same magnetic force and are essentially equal. With this new technology, conditions and results are reproducible over time, with any volume and from lot to lot. Therefore, if a company wants reproducibility, using the new biomagnetic separation technology is vitally important.
If you found this article interesting and want to get a deeper insight in the topic of magnetic bead separation, make sure to check these articles from our blog:
- The 2 ways you can demagnetize your biomagnetic separation device
- Do you have full control of all your steps in your production process?
- Why do magnetic beads move faster than expected?
- The two critical points necessary to achieve homogeneous biomagnetic separation conditions