Sometimes companies scale up production in a magnetic separation rack in order to produce large quantities. However, for validation batches or new processes, they may not need to work at the large scale level. In addition, different steps of the process may require different volumes. For example, if you are producing a large ‘mother batch’ of magnetic beads, different portions of that ‘mother lot’ may be used for unique coatings. Another example is when small validation lots of a product need to be produced before launching full scale production of the product.
When this is the case, one has to consider how to maintain a consistent parameter set during the processing, no matter how large or small the volumes.
This post is about biomagnetic separation with a magnetic separation rack, and how to scale-up this process. If you are interested in this topic, download our free ebook The Basic Guide to Scale-up Biomagnetic Separation Processes:
Homogeneous vs non-homogeneous magnetic separation rack
For non-homogeneous magnetic separation racks, beads will experience very different magnetic forces depending on the scale of the process, even if the same device is used. This is because larger volumes would cause beads farther from the magnet to ‘feel’ much weaker forces than distant beads in smaller volumes.
In contrast, homogeneous biomagnetic separation ensures that all beads experience the same magnetic force regardless of the size of the vessel. Forces experienced by beads in different sized vessels within the same device will not vary.
And what about validation?
For validation purposes you will want to use a smaller volume in a homogeneous system, the only thing you need to vary is the separation time. You will need to have it proportional to the vessel diameter (i.e. the distance the beads must travel). Separation times will be shorter in a smaller system, but since the forces are the same, subsequent effects on the beads will also be the same (such as irreversible aggregation, etc.).
In general, scaling up or down will always be easier with a homogeneous separation system since the magnetic forces are constant. Homogeneous systems are safer, cheaper, and more scalable than non-homogeneous magnetic separation racks.
Don't forget to check these posts from our blog in order to get a deeper insight into the scaling-up of biomagnetic separation processes:
- Why do IVD companies scale up their biomagnetic separation processes?
- Why do different batch volumes require different magnetic fields?
- The 2 Questions to answer before scaling up your magnetic separation rack