Contaminations in parenteral administered pharmaceutical products can cause an inflammatory reaction. This may be limited to mild fever but can also be as strong as septic shock and death. Therefore, detection of these fever inducing substances (pyrogens) are essential prior to any administration. Traditional pyrogen testing methods use rabbits or horseshoe crabs, while not detecting pyrogens in a human specific manner.
Monocytes are a subpopulation of white blood cells, and upon exposure to microbes, they release endogenous cytokines such as interleukin 6 (IL-6). Monocyte activation test detects this reaction in-vitro.
For MAT, human blood cells with monocytes only in their resting state are plated. Then the test substance is added to the plates and the mixture is incubated. If there is any microbial contamination, monocytes will detect these with their toll-like receptors (TLRs). Monocytes express 9 different TLRs and upon detecting foreign substances they give an immune reaction, mimicking the human response in-vivo. Therefore, they provide an effective way of detecting a variety of pyrogens.
In summary, MAT provides several advantages:
InnoSer is partnered with MAT BioTech and CTL-MAT to offer monocyte activation testing services. As part of our services, we use the pyrogen testing kit developed by our partners, which uses pooled PBMCs, and outperforms whole blood cells or monocytic cell lines.
The CTL-MAT kit enables European Pharmacopeia-compliant in vitro pyrogen testing. All components needed for the kit are included: cryopreserved pooled PBMC, IL-6-ELISA, reference standards, reagents and protocols. Every component of the test system has been fine-tuned for optimal performance in MAT and is certified pyrogen free. 8-donor PBMC-pools are included in the CTL-MAT assays, but we also provide services with Ph. Eur. 2.6.30 compliant kits with single donors, or pools of 4-donor PBMC. Each batch is tested for MAT performance after freezing as part of the quality control procedure.
If you are working with parenteral administered drugs and interested in our innovative methods, please get in touch with us via firstname.lastname@example.org.