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Posted on Wed, Jan 23, 2013

The weakest link in IVD production

IVD with magnetic bead separationIn Vitro Diagnostic (IVD) Immunoassays are some of the most successful life science magnetic bead and particle research applications that have come to market. The demand for such technology in hospitals and laboratories in particular, has grown dramatically.

Because of this increased demand, the production of diagnostic kits needs to be scaled up. However, scaling up the production of kits is not always straightforward and can be limited by the need for strict reproducibility of every single piece in the kit. Variations must be minimized since doctors rely on repeatability and consistency when using diagnostic kits.

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:

Free PDF guide:   "Validation of Magnetic Bead Separation Processes" 

Companies that produce In Vitro Diagnostic magnetic bead separation kits rarely pay much attention to the consistency from batch to batch of the magnetic separation steps, the measurements of the process or the control steps in the process. This becomes the weakest link in the production chain when attempting to scale up the production of diagnostic kits.

Ensuring lot consistency of magnetic bead separation kits

How does one ensure the reproducibility of these magnetic bead assays and thus strengthen the weakest link in the production process?

  1. Assure that the assay’s raw materials have very little, if any, batch-to-batch variation. This includes all buffers, magnetic beads, antibodies, etc.
  2. Devote a large amount of effort and investment at each step of the assay:
    1. Production of stable and predictable polyclonal or monoclonal antibodies
    2. Making sure the coating of the beads is performed in a way that is highly consistent. For example, make sure the temperature, pH, and method of suspension are the same from batch to batch.
    3. Understand how to maintain a constant concentration of beads and chemicals from the first to the last aliquot in the lot.
  3. Carefully validate magnetic separation
  4. Understand how heterogeneities during separation can lead to undesirable and irreversible aggregation and uncontrolled losses in product.


The importance of controlling the consistency and reproducibility of IVD lots cannot be stressed enough. Without strict validation of biomagnetic separation processes, the substantial backing and investment that is put into each IVD lotcan be in serious jeopardy.

Learn the importance of magnetic bead separation validationIf 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:

Dr. Lluís Martínez

biomagnetic separation processes

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