New social, ethical & economic impact studies and activities developed by Sanquin

  1. Monocyte Activation Test (MAT), the in vitro human cell-based assay for pyrogen detection replacing the rabbit pyrogen test
  2. Studies on the more economical (cost saving) use of biologics

1. All injectable pharmaceutical products must be free of pyrogenic (fever-inducing) contaminations before they can be safely administered to patients. Sanquin launched a highly sensitive assay for pyrogen detection, the Monocyte Activation Test (MAT). This in vitro human cell-based assay replaces the rabbit pyrogen test, for which currently about 400.000 rabbits are used worldwide on an annual basis. The MAT assay is based on the human immune response by measuring cytokine production of human peripheral blood mononuclear cells.

The European Pharmacopoeia (EP) has officially accepted the MAT as a replacement for the rabbit pyrogen test. Since the revision of the EP chapter on the MAT in 2017, manufacturers of new pharmaceuticals or products that have undergone a change in the production process are legally required to assess whether the MAT is suitable as an alternative to the rabbit test.
The benefits of MAT as a pyrogen test:

Mimics the humane immune response
• Detects all pyrogens relevant to humans
• Does not require the use of animals
• Enables analyzing pyrogenic activity in more complex pharmaceuticals, like:
    o Blood-derived products
    o Cell-derived products
    o Biologics and vaccines

Sanquin offers the MAT both in the form of kits (to perform the assay in your own lab) and as test service (all necessary regulations in place). See for more information: www.sanquin.org/mat



2. Sanquin will contribute to two studies on optimal use of the biologics adalimumab and tocilizumab. Two research grants of the Netherlands Organisation for Health Research and Development (a government funded grant body / ZonMw) of around 1.5 million euros allow Sanquin to measure the blood levels of both biologics. Rheumatologists will subsequently optimise the dose. This research will be led by Reade Rheumatology, Amsterdam.

In the world we prescribe a lot of biologics, very effective but also expensive drugs. The majority of biologics are now prescribed to treat rheumatoid arthritis (RA) and other inflammatory diseases such as Crohn's disease. In 2015 this amounted to 638 million euros in the Netherlands only (18 million inhabitants). Adalimumab is the most prescribed biologic. The registered dose of this medication is the same for all patients. Interestingly, this one-dose-fits-all leads to varying blood levels in patients. Sanquin has shown together with many research groups that the blood level does correlate to clinical efficacy. This has a clear cut-off: higher concentrations do not help the patient but can actually induce unwanted side-effects.

As a result, many patients are over-treated. Sanquin wants to investigate whether the dose can be reduced by up to 70% in patients clinically stable on adalimumab and starting on adalimumab. Finally, we will use drug levels in RA patients who do not respond adequately to hopefully optimise follow-up treatment. Similar questions will be answered regarding tocilizumab. The expectation is that even with a lower dose, patients remain in remission, at significant reduced cost.

This research is necessary to find an optimal concentration, especially as no reference values are given for biologics. Biologics have transformed the treatment of RA and other inflammatory diseases. With the two research grants from medical research funding body ZonMw, Sanquin will contribute to an optimal use and a more cost-effective use of biologics.

https://www.sanquin.org/products-and-services/bioanalysis-of-biologics/index

 

 

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