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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.
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NAT-MAT® Cells

NAT-MAT® Cells are cryopreserved HL-60 derived macrophages, that were produced by differentiation of HL-60 myeloblasts with phorbol-12-myristate-13-acetate. They are ready-to-use and can be seeded directly into a 96-well plate. NAT-MAT® Cells can be used in combination with NAT-MAT® Extraction (Cat. No. 58-0502

Minerva Biolabs

Description

NAT-MAT® Cells

NAT-MAT® Cells are cryopreserved HL-60 derived macrophages, that were produced by differentiation of HL-60 myeloblasts with phorbol-12-myristate-13-acetate. They are ready-to-use and can be seeded directly into a 96-well plate. NAT-MAT® Cells can be used in combination with NAT-MAT® Extraction (Cat. No. 58-0502) and NAT-MAT® dPCR (Cat.No. 58-0503) to perform monocyte activation test (MAT) in order to detect pyrogen contamination in pharmaceuticals. NAT-MAT® Cells are not intended for cultivation. They cannot be passaged.

Components and Package Sizes

Cat. No. 58-0501: 96 reactions

NAT-MAT® Cells (Art.-Nr. 58-0501-1)

  • Component: HL-60 derived macrophages
    • Quantity: 1 vial, approx. 3x106 - 5x106 cells/ml (exact concentration can be found in CoA)
    • Shipment: Dry ice
    • Storage conditions upon arrival: ≤-150 °C or liquid nitrogen

NAT-MAT® Accessories (Art.-Nr. 58-0501-2)

  • Component #1: 96-well Zellkulturplatte
    • Quantity: 1 plate
    • Shipment: Ambient temperature
    • Storage conditions upon arrival: Umgebungstemperatur
  • Component #2: Cell Medium
    • Quantity: 1 bottle 30 ml
    • Shipment: Ambient temperature
    • Storage conditions upon arrival: 2 bis 8 °C
  • Component #3: Assay medium
    • Quantity: 1 bottle 20 ml
    • Shipment: Ambient temperature
    • Storage conditions upon arrival: 2 bis 8 °C

Please note, that NAT-MAT® Cells components are shipped in two separate packages due to different shipment conditions.

Required Lab Device and Consumables
  • 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)
Shipment, Shelf Life, and Storage

Shipment with dry ice and ambient temperature. The expiry date of the unopened package is marked on the package label. 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.

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.


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