Cambio - Excellence in Molecular Biology

PCR

PCR : Pyrogen Testing

Pharma/ATMP 

As the field of personalized cell and gene therapies rapidly advances, so does the need for rigorous quality control measures. Quality control in biopharmaceutical and ATMP production is essential to ensure the safety, efficacy and quality of these advanced therapies. Unlike conventional pharmaceuticals, which are often chemically synthesized and standardized, ATMPs are biological products derived from living cells or tissues, making them inherently more complex and variable. Therefore, robust quality control measures are necessary throughout the manufacturing process to mitigate risks and ensure product quality.

Minerva Biolabs supports you with innovative product solutions for ensuring the quality control of your biopharmaceutical/ATMP product in compliance to regulatory guidelines with:

  • Regulatory mycoplasma testing
  • Residual host cell DNA testing
  • Vector copy number determination
  • Complete pyrogen testing

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.

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