When biomagnetic particle kits are initially developed, R&D companies work with small volumes in a magnetic separation rack in order to test and optimize a number of variables. When the kit is deemed successful, the company obviously wants to take the kit to market and consequently ramp up production.
With just a few hundred milliliters of material, a company can generate a number of kits. However, as demand increases, the IVD company needs to be able to continually grow to cope with that demand. If the process cannot be scaled up, the biomagnetic separation process will become the bottleneck for the company.
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:
At the point of slow market growth, the company can consider merely duplicating the number of lots. But having separate small lots can be problematic because the company must make sure the lots are consistent. They must quality control each lot and characterize each lot independently. If this type of production is pursued as the demand grows, resources such as those needed for the coating steps, resuspension steps and quality control steps will be prohibitively expensive for the company.
Advantages of increasing the lot volume
Increasing the lot volume once the demand increases is highly advantageous because it allows companies to:
Minimize the number of quality control checks necessary – one would only have to QC check the large volume lot before it is aliquoted into kits.
Decrease labor costs since the time necessary to produce a large volume of material is only slightly longer than or the same as the time necessary to produce a small volume of material.
Easily trace kit problems to a particular lot since many kits come from the same batch.
Enjoy all of the economies of scale.
A word of caution: All of the benefits of scaling up production of biomagnetic separation processes vanish if the conditions of the process are not well-defined.
Therefore, it is advantageous in many ways for a company to ramp up production as soon as they feel the market demands more supply of the product. This scale-up process must be done carefully so that large lots are not only internally consistent but as consistent as possible with each other.
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 different batch volumes require different magnetic fields?
- The 2 Questions to answer before scaling up your magnetic separation rack
- 4 usual problems when configuring a large volume processing system