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<b>New </b> - Biopharma Quality Control

New - Biopharma Quality Control : Pyrogen testing

Pyrogen Testing

 

Complete Pyrogen testing by combining the power of digital PCR with Monocyte Activation Test (MAT)- Minerva Biolabs' NAT-MAT®.


  • Replacing the Rabbit Pyrogen Test
  • Ph. Eur. 2.6.30 compliant
  • Excellent reproducibility
  • Enhanced precision and Sensitivity
  • Highly automated workflow
  • Compatible with QIAcuity® dPCR platform
  • Time-to-Result: 1 day
  • Analysis of results with easy-to-use software

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.

 

Find more information on Minerva Biolabs' NAT-MAT® in our flyer.
Download Flyer

NAT-MAT® Extraction

NAT-MAT® Extraction is a magnetic bead-based extraction kit and was specifically developed for nucleic acid extraction from NAT-MAT® Cells. Extraction process can be performed automatically (e.g. with KingFisher™ Flex). Manual extraction is also possible but not recommended.

Minerva Biolabs

Description

NAT-MAT® Extraction

 

NAT-MAT® Extraction is a magnetic bead-based extraction kit and was specifically developed for nucleic acid extraction from NAT-MAT® Cells. Extraction process can be performed automatically (e.g. with KingFisher™ Flex). Manual extraction is also possible but not recommended.

NAT-MAT® Extraction can be used in combination with NAT-MAT® Cells (Cat. No. 58-0501) and NAT-MAT® dPCR (Cat. No. 58-0503) to perform monocyte activation test (MAT) in order to detect pyrogen contaminations in pharmaceuticals.

Components
  • Binding, Elution, Lysis, Rehydration, and Wash Buffers
  • Magnetic Bead Suspension
  • Proteinase K
Package Size

Cat. No. 58-0502: 96 reactions

Required Lab Device and Consumables
  • 1-propanol, ≥99,5 %, p.a.
  • Automated extraction device (e.g. KingFisher™ Flex)
  • 96-well plates for automated extraction device
  • For manual extraction (not recommended): thermal shaker and magnetic rack
Shipment, Shelf Life, and Storage

Shipment and storage at ambient temperature. The expiry date of the unopened package is marked on the package label. Proteinase K has to be stored at 4 °C upon arrival.

Do you prefer an all-in-one system, that provides all necessary components for performing MAT?
Have a look at NAT-MAT® All-in-One System that consists of NAT-MAT® Cells, NAT-MAT® Extraction and NAT-MAT® dPCR.

Manual.pdf
SDS.pdf
Flyer.pdf

 


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