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® 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