Sanquin launches new drug safety test that reduces animal testing
Sanquin, the organisation responsible for the blood supply in the Netherlands, has launched a product that tests the safety of injectable drugs in a petri dish, sparing tens of thousands of laboratory animals (rabbits) from being used.
The Amsterdam-based organisation, which also provides several lab tests and diagnostic services for hospitals, medical institutes and pharmaceutical companies, has developed an improved version of its innovative Monocyte Activation Test (MAT).
Today (October 4), on World Animal Day, Eelo Gitz and Marijke Molenaar from Sanquin explain why MAT matters:
What is the MAT and what does it do?
To ensure patient safety, all injectable drugs (such as vaccines or insulin) need to be tested for the presence of fever-inducing substances (pyrogens). To test whether a newly formulated injectable medicine causes a fever, the Monocyte Activation Test (MAT) mimics the immune response in a petri dish. The monocyte – a certain type of human immune cell – becomes active if the medicine contains a pyrogen and starts to release signaling molecules, which in the human body results in fever. In the MAT, the release of these so called cytokines is measured and this determines whether the pyrogenic load of the tested pharmaceutical product is within the safety limits.
What are the advantages of the MAT?
In contrast to the Rabbit Pyrogen Test, the MAT measures the human immune response, rather than that of a laboratory animal. The assay is therefore capable of detecting all types of pyrogens that are relevant to humans. The MAT can also be used for complex pharmaceutical products like blood- or cell-derived products, biologicals and vaccines. And, thanks to this “petri dish” test, injectable medicines can now be tested for safety without the use of rabbits. Worldwide, 400,000 rabbits are used for this test every year and put down afterwards. Each donation of human blood used for the MAT can save up to 500 rabbit lives.
How are MAT kits produced and distributed?
The immune cells used in the MAT are obtained from human blood donations. The donors arrive at Sanquin in the early morning to voluntarily donate blood for this purpose. That same day, Sanquin purifies the immune cells (monocytes) from the donations and preserves them by means of freezing. After extensive quality control, the cells are ready and used to perform the MAT in-house or shipped (on dry ice) to customers.
What are its real-world applications?
Since 2017, pharmaceutical companies in the EU are obliged to use the MAT as an alternative to the Rabbit Pyrogen Test for new medicines or existing medicines where the production process has changed. More recently, the European Pharmacopoeia Commission has decided to completely replace the Rabbit Pyrogen Test within the next five years. Sanquin provides an all-encompassing solution for this test in the form of test kits, test services, consultancy and support. Current customers include pharmaceutical companies from the world top 5 as well as smaller scale enterprises. The type of products being tested by Sanquin include blood-derived pharmaceuticals, biologicals and vaccines, from the experimental phase of development to established drugs on the market (routine drug release testing).
Sanquin released its first MAT kit in 2017, and now a new version will be launched. What is the difference between them?
The MAT kit launched in 2017 was developed using fetal bovine serum (FBS). This animal-derived product is traditionally used to support the growth of cells in the lab. In the new kit this component has been replaced by human serum, which, similar to the immune cells, is also obtained from blood donation. The use of human serum not only further reduces the use of animal-derived components, the assay also becomes more sensitive to an important group of fever-inducing substances.
How successful have the kits and services been so far?
There is increasing interest in the MAT, in part driven by regulatory requirements but also driven by increased awareness of its safety and by the fact that the test does not require the use of laboratory animals. To allow for a world-wide distribution of the MAT kits, Sanquin has formed a strategic partnership in 2020 with the biotech company Lonza in 2020. In terms of providing the MAT as a test service, Sanquin is building a strong customer base, which includes major pharmaceutical companies, biotech companies and contract manufacturing organisations.
What makes Amsterdam a good place for this kind of innovation?
The Amsterdam region offers an excellent ecosystem for innovation and cooperation. The Dutch capital finds itself in close proximity to the Amsterdam Airport Schiphol, several railway stations and relevant agencies such as the European Medicines Agency, as well as universities and life science institutes and is a well-loved city in which to reside.
The Amsterdam municipality promotes cooperation between knowledge institutes and industry and invests in profiling of the Amsterdam metropole as a knowledge intensive region. Recently, the New West Health & Innovation District (HID), founded by Sanquin and located on its premises, was granted a €500,000 subsidy to expand office and laboratory space to house startups in the field of blood, immunology, haematology or cancer.