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 E.P. (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 E.P. (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.
Pyrogen/Endotoxin
test
LoD
(EU/ml)
Limulus Amebocyte Lysate (LAL)
0.005
Recombinant Factor C (rFC)
0.005
Rabbit Pyrogen Test (RPT)
0.5
Monocyte Activation Test (MAT)
0.004
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
✔
Endotoxins (from Gram-negative bacteria)
✔
✔
✔
Yeasts & molds
✔
✘
✘
Gram-positive
bacteria
Viruses
✔
✔
✘
✔
✔
✔ / ✘
✘
✘
Possible applications
Pharmaceuticals
✔
✔
✔
Biologicals
✔
✔ / ✘
✔ / ✘
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 kit?
The monocyte activation test can make use of an array of different cell sources. As outlined below, each offers varying strengths and weaknesses.
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 E.P. 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.
Monocyte Activation Test kit vendor comparison
The CTL-MAT Monocyte Activation Test kit promises what others simply can't.
0.004
EU/ml LoD
The lowest limit of detection
The CTL-MAT Monocyte Activation Test kit detects contaminations in products with low endotoxin specifications that other kits can't.
2,000
Kits per batch
Largest Monocyte Activation Test batches
Lets you always make sure your test samples undergo stable and consistent conditions across different trials and validation stages.
15
Years experience
Longest Monocyte Activation Test history
Call upon a team comprising the very first pioneers of MAT. Whatever your challenge, we've already seen and overcome it.
Market leading reactivity, sensitivity and reproducibility.
Highest reactivity & sensitivity
-
0.5 EU/ml LPS can produce up to 10,000
Picogram/ml IL-6. -
The LLOD of the international endotoxin standard LPS E. coli is determined as (or equal to) 0.004 EU/ml​.
Highest intra-batch reproducibility
-
The above visualises the standard curve across 4 vials from the same batch.
-
As illustrated, our MAT kit promises almost perfect reproducibility within each batch​.
Highest inter-batch reproducibility
-
The diagram above visualises the standard curve across vials from 4 different batches.
-
As illustrated, our MAT kit promises almost perfect reproducibility across different batches​.
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.
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:
-
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.
-
Using an 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.
MAT Media A & B
Culture media to
dilute standards and products.
EDQM LPS E. Coli
International endotoxin standard LPS
(Lipopolysaccharide).
Non-Endotoxin Pyrogens
R-848 (Reiquimod) and SAC (PANSORBIN® Cells), included upon request.
IL-6 ELISA Kit
Contains all reagents, coated microplate and IL-6 standard.
Pooled PBMC
1 ml (5 million cells)
of cryopreserved
4 donor pooled PBMC.
96-Well Microplate
Culture plate for incubating product, standard and PBMC.
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.