Next level Monocyte Activation Testing (MAT)

Whether you have products with low contaminant limit concentrations, LER effects or you require large batches of Monocyte Activation Test kits — our Monocyte Activation Test delivers solutions you won’t find anywhere else.

What is Monocyte Activation Testing?

The Monocyte Activation Test principle is based on the simulation of the human immune systems response to endotoxin and non-endotoxin pyrogens. Specifically, a drug sample is incubated in human monocytes which respond to possible pyrogenic contaminations by producing pro-inflammatory cytokines such as IL-6. The cell culture supernatant is then analyzed with an IL-6 ELISA kit which detects and quantifies any released IL-6 cytokines.

Rabbit Pyrogen Test (RPT) replacement

The EP (2.6.8) has mandated that where possible, and after product-specific validation, pharmaceutical producers must transition from the Rabbit Pyrogen Test to the Monocyte Activation Test as a release pyrogenicity assay.

Bacterial Endotoxin Test (BET)
risk assessment

For those employing Bacterial Endotoxin Test as a release assay, the EP (5.1.10) stipulates that the presence of non-endotoxin pyrogenic substances must also be ruled out by way of a risk assessment – specifically, the Monocyte Activation Test.

Sensitivity of the Monocyte Activation Test vs. other pyrogen/endotoxin detection assays

When compared to the other endotoxin or pyrogen tests available on the market, the Monocyte Activation Test – specifically MAT BioTech's CTL-MAT kit based on the cryopreserved donor-pooled PBMC – promises the most sensitive assay.

Detection and application of pyrogen/endotoxin tests

Assay capabilities

Rabbit 
Pyrogen Test
(RPT)

Limulus Amebocyte
Lysate (LAL)

Recombinant Factor C
(rFC)

Monocyte Activation Test (MAT)

Detectable pyrogenic contaminations

✔

Gram-positive
bacteria

Viruses

✔

✔

✘

✔

✔

✔ / ✘

✘

✘

Possible applications

Medical devices

Cell therapeutics

✔

✔ / ✘

✔ / ✘

✔ / ✘

✔

✔

✘

✔ / ✘

✔ / ✘

✔

"We're starting to use the Monocyte Activation Test as a release assay instead of BET or RPT"

Particularly due to its higher sensitivity and ability to detect both endotoxins and non-endotoxin pyrogenic contaminations, large medicinal product manufacturers like Pfizer, GSK and Sanofi are employing Monocyte Activation Tests as their batch release assay for vaccines and other parenteral drugs or medical devices.

The Monocyte Activation Test will help you —

Test products with a low contaminant limit concentration (CLC)

MAT BioTech's CTL-MAT Monocyte Activation Test kit is helping detect endotoxin and non-endotoxin pyrogens in products with an extremely low CLC through its market leading 0.004 EU/ml lower LOD. 

Curb low endotoxin recovery (LER) effects

The CTL-MAT Monocyte Activation Test kit of MAT BioTech acts as a key tool in helping teams dealing with Low Endotoxin Recovery (LER) effects while using LAL or rFC due to its uniquely low susceptibility to interfering factors.

Test biologicals

Particularly for products that are complex, adjuvanted or intrinsically pyrogenic, the Monocyte Activation Test promises a markedly simplified, in-vitro release assay.

Overcome synergistic effects

Rather than the enzymatic reaction that LAL or rFC is based on, the Monocyte Activation Test's biological reaction promise it can detect any possible synergistic effects between endotoxins and NEPs.

Are there different types of Monocyte Activation Test kits?  

A Monocyte Activation Test kit based on 4 donor pooled, cryopreserved PBMC is always the way to go.

Because it's based on the peripheral blood of a patient with monoblastic leukemia, the Mono-Mac 6 (MM6) cell line is by nature restricted to a single donor and does not promise a healthy expression of the required receptors for the Monocyte Activation Test. As a result, the degree of reproducibility both within and across batches of MM6 monocyte activation test kits is very low. What's more, the EP warns that the MM6 based Monocyte Activation Test is limited in its ability to detect NEPs. In other words, like a BET, a further risk assessment for NEP contamination would be necessary when employing it as a release assay.

The CTL-MAT Monocyte Activation Test kit promises what others simply can't.

Market leading reactivity, sensitivity and reproducibility.

Unlike any other manufacturer, we provide market leading results across batches of up to 2,000 monocyte activation test kits at a time. This owes to our robotised large scale production facilities. Such a scale is crucial in being able to ensure test samples undergo stable and consistent conditions across different trials and validation stages. 

— Reach out to us for a list of available batches

kits per batch of 4-donor
pooled PBMC

2,000

How does our

Monocyte Activation Test kit work?

Our Monocyte Activation Test is carried out as follows:
 

1. The peripheral blood mononuclear cells (PBMC) are stimulated for release of inflammatory cytokines with a product preparation that may contain a pyrogenic contamination during an overnight cell culture step.
    

2. Using a human IL-6 ELISA kit, the cell culture supernatant is tested for released cytokines on the following day. Using an absorbance reader, the color reaction is measured. The pyrogenic content of the sample is then analyzed against the RSE and is expressed in Endotoxin Equivalent Units (EEU/mL).

Our Monocyte Activation Test kit includes everything you

need to get started.

2 x Non-Endotoxins

Includes both heat-killed Staphylococcus aureus (HKSA) and R848 (Resiquimod).

Our five star support team will be there, every step of the way.

Whether or not you're using our Monocyte Activation Test kit, our support team would be happy to help you set-up your Monocyte Activation Test laboratory to deliver robust and reliable results like never before.

Get in touch with us

for a quote.

Simply fill out our contact form and one of our team will reach out to you

to understand what your need is and give you a price quote.

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