Pyrogen Testing
Kits designed for next generation MAT system that measures the gene expression of IL-1ß and TNFa using digital PCR - the NAT-MAT®. The NAT-MAT® enables complete pyrogen testing and detects endotoxin as well as non-endotoxin pyrogens.
Pyrogen Testing
In the pharmaceutical industry, pyrogen detection is mandatory to
avoid life-threatening fever reactions that can be induced by both
microbial and non-microbial substances. Traditionally, this test relied
on animal-based methods, like the rabbit pyrogen test (RPT). With
increasing awareness of ethical concerns and growing demand for
alternatives, the Monocyte Activation Test (MAT) was introduced into the
European Pharmacopeia (EP) in 2010 – providing a human in vitro system
to detect and quantify pyrogenic substances in pharmaceutical products.
Since the RPT will be discontinued in 2026 in Europe, regulatory
authorities currently encourage manufacturers to implement MAT in their
QC system.
The MAT is based on the activation of monocytes by pyrogenic
substances present in the sample. Upon exposure to potential pyrogens,
monocytes undergo a signalling pathway resulting in secretion of
pro-inflammatory cytokines, such as IL-1β, TNFα and IL-6.
Minerva Biolabs has developed a next generation MAT system that
measures the gene expression of IL-1β and TNFα using digital PCR - the
NAT-MAT®. The protocol is optimized for fast and reliable pyrogen
detection and offers robust and highly sensitive results. The NAT-MAT®
enables complete pyrogen testing and detects endotoxin as well as
non-endotoxin pyrogens. The test can be conducted as in-process control
and as final release testing of medicinal products according to Ph. Eur.
2.6.30. Analysis of the results can be done automatically by Minerva
Biolabs´ easy-to-use analysis software.
