In a standard magnetic separation rack, scaling up to a larger lot volume usually creates four common problems:
The most frequent concern when considering the use of modern Biomagnetic Separation Systems is their compatibility with specific magnetic beads. Although Sepmag® devices are already working successfully in IVD labs and production lines, this is a very legitimate question.
It is vitally important to understand the process and all of the variables of the process when scaling up a biomagnetic separation in a magnetic separation rack. If you do not understand the details of your process, you will throw away your initial investment you made in validating your initial process and jeopardize the product’s time to market.
The most common mistake when attempting to scale up production of magnetic beads using a classical magnetic separation rack is to use the same magnetic field that was used at smaller volumes. But keeping the magnetic field constant at different volumes will not give you the same results because the separation conditions are completely different.
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.
The main consumers of magnetic beads are In Vitro Diagnostic (IVD) companies who utilize these materials for their kits. Since some of these companies are highly successful, as they obviously need to cope with higher demand for their kits by increasing production in a magnetic separation rack.
When you decide to scale up your process, one of the most difficult parameters to determine in a non-homogeneous magnetic separation rack is the separation time. In scaled-up non-homogeneous devices, you must use longer separation times in order to gain the same bead yield as a smaller process. However, it is still difficult to determine when the separation is complete.
When you have systems that have large standard open magnets that can generate stray fields, such as a non-homogeneous magnetic separation rack, the devices can be very dangerous. The magnetic fields generated all around the device and are known to have caused laboratory accidents in the past. Scaling up a process means that the stray fields will increase quickly with the size of the device.
Working with a magnetic separation rack, at small volumes it is easy to create and use a quadripol electromagnet to generate high forces during biomagnetic separation processes, even to the point of making the process very close to homogeneous. The main advantage to using electromagnets for this type of process is the ability to easily modify the current passing through the magnetic coils, thus modifying the value of the magnetic field and force during the setup of your process.
When companies desire to increase the volume and scale up their production using a non-homogeneous magnetic separation rack, they use higher magnetic forces in order to separate the biomagnetic beads. As a result, the forces experienced by the beads nearest the magnet are extremely high. In addition, the time of separation also needs to be increased substantially when the volume is increased in order to collect an acceptable percentage of beads in a non-homogeneous system.
