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Mistake #1 in CLIA IVD-kit manufacturing: Blaming the magnetic beads

Product development is a time-consuming, expensive process for CLIA-IVD kit manufacturers. There are several steps involved: 

  • Selecting the biomarker
  • Choosing the right coupling 
  • Selecting the right magnetic bead 

You are well versed with the first two points but what is “the right bead”? Assuming you have the right biomarker and a perfect coupling, the ideal magnetic bead should have the following properties:

  • High recovery/fast separation, compatible with the timing of the analyzer step. It needs to be fast enough during large-scale production processes without high bead and coupled biomarker losses.
  • No aggregation problems. Beads should be easy to re-suspend. It makes no sense to separate quickly if several additional sonication steps are required, which are difficult processes to control/implement in large volumes.
  • Low kit-to-kit variability. Batch aliquots (typically less than a milliliter) of production batches (liters scale) must be consistent. If not, variability causes problems when interpreting the results in the analyzer.


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How can we specify a Biomagnetic Separation Process?

When a new CLIA-IVD kit is transferred from R&D to production, all the manufacturing protocols should be adapted to the new throughput and volume. Biomarker specifications, buffers and coating protocols would benefit from the cumulated experience in non-magnetic kits. Coupling an antibody to magnetic beads is quite similar to doing it in colloidal gold or latex particles. But the washing protocols using Biomagnetic Separation are something new. The use of classical (and dirty) centrifugation method makes not so much sense when we can use the magnetic properties of the beads. Similar reasoning applies to the use lateral flow filtration or other complex and time-consuming non-magnetic separation techniques.

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How do Sepmag® Systems work with ESTAPOR® magnetic microspheres?

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.

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New paper about the behavior of magnetic beads separation

Learning more about the behavior of magnetic beads separation when strong magnetic fields are applied


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Determining the Right Separation Time during Biomagnetic Separation Processes

When one scales up production using a classic magnetic separation system, one finds that the separation time increases quickly with an increase in production volume. An increase in separation time means that material losses are higher and aggregation problems become a serious problem. By using homogenous separation time, one finds that the magnetic separation process is shorter and the separation time can be easily estimated. In homogeneous systems material loss and bead aggregation is minimized. 

Download our FREE guide about Biomagnetic Separation for Production HERE
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Three Questions to Help You Decide What Technique to Use for Magnetic Bead Mixing and Homogenizing

Magnetic beads need to be constantly mixed and homogenized to avoid sedimentation and clumping problems. Even when the sonication method is necessary to break up aggregates, mixing and homogenization is necessary.

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How do concentration changes affect Biomagnetic Separation Processes?

In the Life Sciences, one of the most critical parameters for final IVD kit performance is magnetic bead concentration. The beads are functionalized before the magnetic separation process with antibodies or other biological molecules, so the concentration of magnetic beads also delivers a specific concentration of biologically active reagent. If you do not have the correct amount of beads/biological molecules in your preparation, the sensitivity of the kit changes significantly. Therefore volume control of the suspension is quite important.

Download our FREE guide about Biomagnetic Separation for Production HERE
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Monitoring with Homogenous Biomagnetic Separation to detect QC Issues

In non-homogenous magnetic separators, monitoring the entire separation process is difficult to impossible. As a result, errors in the magnetic separation process, such as using the wrong magnetic beads or using buffers with the wrong properties are not detected until the final QC testing stage.

Download our FREE guide about Biomagnetic Separation for Production HERE
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Issues with lot-to-lot inconsistencies in magnetic bead processing

When magnetic bead reagents are produced in quantity, often you cannot know if you have the correct properties of the beads until the final quality control step. But if these properties are wrong, finding out the properties at the end of the magnetic separation process for production does not allow you to salvage the lot. Knowing magnetic bead properties, such as size, magnetic charge and surface charge, is critical in order to have excellent reproducibility in the final product (e.g. IVD kits).

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