Often when a lab produces a product that becomes popular, the impetus is to move forward and scale up production of that product. The problem is that moving from the production of small lots to full scale production usually produces surprising results. Scaling up is not trivial, and the magnetic separation process is no exception. When one scales up production, results become very inconsistent.
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 is scaling up so difficult?
Why would this be? Why can’t researchers and technicians take the parameters from small production processes and translate them directly into large production processes?
The answer is quite simple. In small lab lots separation conditions are often defined on a very specific device for a very specific separation time. The process is dependent on empirical experience and on the condition of the machine at any given time. Usually this device used for lab lot production for testing and development of a product is a simple device with single magnets. Furthermore, the final use of IVD kits is typically in an automated diagnostic machine and so these lab lots are developed with that usage in mind.
But for all of these aforementioned cases, the linear and saturated magnetic state of the magnetic beads during the actual process is neither well-known nor well-quantified. If that is the case, then the magnetic force is also not well-defined. If one does not know these parameters well, then one cannot by extension, transfer well-defined biomagnetic separation conditions to a large scale production. When this happens, the consistency of the batches is greatly compromised.
There are two alternative solutions to these problems. The expensive solution is to investigate and define, in detail, what conditions are used in small scale production. Then, moving to larger scale production, try to redefine the conditions as best as possible.
The better and less expensive solution is to use homogenous biomagnetic separation conditions from the start, since scaling up homogenous processes is straightforward.
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
- Production of magnetic beads kits: To be magnetic or not to be?
- The Set up of Biomagnetic Separation Production Processes