Lonza and Sanquin Partner for Commercialization of MAT

Lonza Bioscience and Sanquin Reagents B.V. have entered into a strategic partnership for the commercialization of the Monocyte Activation Test (MAT). This partnership expands Lonza’s extensive portfolio of endotoxin testing products, and enables drug developers and quality control (QC) laboratories to explore the full potential of the sustainable MAT method to bring safe pharmaceuticals to the market. The MAT Assay completes our QC Testing portolio as the Rabbit Pyrogen Test (RPT) is no longer permitted in the EU.

The cryopreserved pooled human Peripheral Blood Mononuclear Cells (PBMCs, pooled from 4 healthy human donors) are produced by Sanquin specifically for use with the MAT. They will now be sold as PyroCell™ MAT Assay and include an optimized MAT Culture Medium Supplement. The cells are developed in line with the requirements of the European Pharmacopoeia chapter 2.6.30, following an optimized donor selection, cell isolation and cell quality testing process. The cells are available on demand and the large number of vials from one batch guarantees a long term test consistency. In addition, Lonza will distribute the Sanquin-branded PeliKine compact Human IL-6 ELISA Kits that have been validated for use with the MAT assay to detect the released cytokine IL-6.

In contrast to LAL, the monocytes, which are the key cells of innate immunity, respond not only to endotoxin but to non-endotoxin pyrogens (NEP) in general. The immune response is the production of cytokines such as IL-6 during a stimulation period. IL-6 offers the advantage of being fully secreted. Therefore, the cell culture supernatant containing the released IL-6 cytokines can be easily analyzed with a traditional ELISA assay.

For your convenience, we offer all components that enable you to perform the complete procedure:

• PyroCell™ MAT Cells & Supplement: Sufficient for 3 plates
• PeliKine Compact IL-6 Kit: Antibodies, reagents, and plates (ELISA kit)
• PeliKine Tool Set: Buffers needed for the ELISA, included in the ELISA kit

And of course we provide all consumables to perform the MAT like IMDM, plates, tips, dilution tubes and reagent reservoirs, as well as hardware like the ELx808 reader. An analysis tool is being developed as well that will be implemented in our WinKQCL software.

QC laboratories will now profit from a comprehensive and optimized MAT solution that is in line with regulatory requirements.

Don’t hestitate to reach out to us if you have any questions or visit our MAT application page for further information.

Our Product Specialists and Scientific Support Team will be happy to discuss any open questions with you.

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