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® dPCR

NAT-MAT® dPCR provides a lyophilized primer/probe mix and parallelly measures the gene expression of two cytokines – IL-1ß (HEX™) and TNF-a (Cy5®) – and one housekeeping gene (FAM™) in a triplex PCR reaction. NAT-MAT® dPCR can be used in combination with NAT-MAT®

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
NAT-MAT® dPCRNAT-MAT® dPCR96 reactions POA Quantity Add to Order

Description

NAT-MAT® dPCR

NAT-MAT® dPCR provides a lyophilized primer/probe mix and parallelly measures the gene expression of two cytokines – IL-1β (HEX™) and TNF-α (Cy5®) – and one housekeeping gene (FAM™) in a triplex PCR reaction. NAT-MAT® dPCR can be used in combination with NAT-MAT® Cells (Cat. No. 58-0501) and NAT-MAT® Extraction (Cat. No. 58-0502) to perform monocyte activation test (MAT) in order to detect pyrogen contaminations in pharmaceuticals.

Type of PCR

Digital PCR (dPCR)

Components
  • NAT-MAT® Mix (lyophilized)
  • Positive Control DNA (lyophilized)
  • dPCR grade Water
Package Size

Cat. No. 58-0503: 96 reactions

Result Evaluation

Absolute Quantification

Required Lab Device and Consumables
  • 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

Shipment at ambient temperature. The expiry date of the unopened package is marked on the package label. 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.

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