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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® All-in-One System

NAT-MAT® All-in-One System provides all necessary components, including cells, extraction system, and dPCR assay to perform monocyte activation test (MAT) in order to detect pyrogen contaminations in pharmaceuticals.

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
58-0511NAT-MAT® All-in-One System96 reactions POA Quantity Add to Order

Description

NAT-MAT® All-in-One System

NAT-MAT® All-in-One System provides all necessary components, including cells, extraction system, and dPCR assay to perform monocyte activation test (MAT) in order to detect pyrogen contaminations in pharmaceuticals.

The NAT-MAT® system relies on the use of NAT-MAT® Cells which are stimulated with a pyrogen standard and the sample to be tested followed by nucleic acid extraction (NAT-MAT® Extraction) and subsequent dPCR analysis of the gene expression of IL-1β and TNF-α (NAT-MAT® dPCR). By simultaneously measuring the gene expression of a housekeeping gene, the pyrogenic load can be normalized to the cell number, which allows highly accurate results.

Components
  • NAT-MAT® Cells (Cat. No. 58-0501)
  • NAT-MAT® Extraction (Cat. No. 58-0502)
  • NAT-MAT® dPCR (Cat. No. 58-0503)
Package Size

Cat. No. 58-0511: 96 reactions

Result Evaluation

Absolute Quantification

Required Lab Device and Consumables

NAT-MAT® Cells:

  • Liquid nitrogen or ≤-150 °C ultra-freezer
  • CO2 Incubator
  • Laminar airflow cabinet
  • Water bath
  • Centrifuge (for 15 ml falcons)
  • 15 ml falcon tubes
  • Fetal bovine serum
  • Inverted microscope (optional)
  • Reference standard endotoxin (RSE), e.g. preparations from USP or EP (BRP)
  • Sterile, non-pyrogenic water (LAL water)
  • 2 relevant non-endotoxin pyrogens (optional)
  • Pyrogen-free glass tubes
  • Microcentrifuge
  • Vortex mixer
  • Pipettes with corresponding filter tips (10 μl, 100 μl, and 1000 μl)
  • Multi-channel pipette (optional)

NAT-MAT® Extraction:

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

NAT-MAT® dPCR:

  • QIAcuity® digital PCR system
  • QIAcuity® Nanoplate 8.5k 96-well
  • QIAcuity® OneStep Advanced Probe Kit
  • Nanoplate tray
  • Nanoplate seal
  • 1.5 ml reaction tubes
  • Microcentrifuge for 1.5 ml PCR tubes
  • Vortex mixer
  • Pipettes with corresponding filter tips
  • Pipetting robot (optional, e.g. QIAgility® with nanoplate adapter)
Shipment, Shelf Life, and Storage

The expiry date of the unopened package is marked on the package label.

NAT-MAT® Cells: Shipment with dry ice (cells) and ambient temperature (cell culture media and plate) in 2 separate packages. The cells must be stored at ≤-150 °C or liquid nitrogen until use. The cell culture media must be stored at 2 to 8°C until use.

NAT-MAT® Extraction: Shipment and storage at ambient temperature.

NAT-MAT® dPCR: Shipment at ambient temperature. The kit components must be stored at 2 to 8°C until use. The rehydrated components must be stored at ≤ -18°C for a maximum of one month.

Manual.pdf
SDS.pdf
Flyer.pdf

If you cannot find the answer to your problem then please contact us or telephone +44 (0)1954 210 200