PyroMAT (MM6 cell-line) vs. CTL-MAT (PBMC) MAT kit comparison

The two leading MAT kits on the market are Merck's PyroMAT system based on the mono-mac-6 (MM6) cell-line and the CTL-MAT kit based on 4 or 8 donor-pooled peripheral blood mononuclear cells (PBMC). Here's how they fare, head-to-head.

Not all MAT kits were created equal. The two most common types of MAT kit are those based on the mono-mac-6 (MM6) cell-line like Merck's PyroMAT system and those based on peripheral blood mononuclear cells (PBMC), like CTL-MAT's.

As the frontrunner of MAT innovation, MAT BioTech's CTL-MAT monocyte activation test kit has evolved over 15 years of rigorous research and development. One of the most important decisions made when designing it was the (blood) cell source on which it is based.

 

Unlike the team behind the PyroMAT kit, after in depth testing and analysis of the MM6 cell-line the scientists at MAT BioTech were not satisfied with its performance, believing that a truly efficacious test would only be possible using the blood of healthy donors as its basis. Below we've included a breakdown of the strengths and weaknesses of both the PyroMAT and CTL-MAT kit as a result of their choice for MM6 and PBMC, respectively.

Donor variation of PyroMAT system vs. CTL-MAT kit

The PyroMAT system is based on the cell-line mono-mac-6 (MM6) which derives from the blood of a single, acute monocytic leukemia patient. Unlike the PyroMAT, the CTL-MAT kit is based on the cryopreserved peripheral blood mononuclear cells (PBMC) of pools of upto 8 healthy human donors. This pooling ensures that, like the PyroMAT system, the CTL-MAT kit has eliminated any possible risk of donor variation. 

Comparison

PyroMAT
system

CTL-MAT kit

Low risk of donor variation

Reproducibility of PyroMAT system vs. CTL-MAT kit

Comparison

PyroMAT
system

CTL-MAT kit

Reflects behaviour of healthy monocytes

The CTL MAT kit sources its PBMC from the pooled blood of screened, healthy donors which means when incubated with a spiked product sample, the process of monocyte activation can be counted on to reliably simulate that of a healthy human. Because the PyroMAT system on the other hand is based on the blood of a monocytic leukemia patient, the monocytes have been observed to fail in having a stable expression of the toll-like receptors (TLRs) required to detect pyrogenic contaminants and initiate the release of cytokines as a healthy human's would. As a result, the reproducibility of PyroMAT test is comparatively significantly lower than that of the CTL-MAT kit.

Sensitivity of PyroMAT system vs. CTL-MAT kit

For products with interfering factors or low contaminant limit concentrations (CLC), the sensitivity or limit of detection (LoD) of a release assay is crucial in facilitating the use of a maximum valid dilution (MVD) of a product that is high enough to deliver an LPS recovery percentage within the allowable range of 50%-200%. While the PyroMAT system has an LoD of 0.05 EU/ml, the CTL-MAT kit is significantly more sensitive with an LoD of 0.004 EU/ml. This means there are significant limitations when it comes to the variety of products the PyroMAT system can successfully validate or the different types of obstacles it can help overcome, comparatively.

Comparison

PyroMAT
system

CTL-MAT kit

Limit of Detection (LoD)

0.05 EU/ml

0.004 EU/ml

Ph. Eur. approval of PyroMAT system vs. CTL-MAT kit as complete pyrogen test

Comparison

PyroMAT
system

CTL-MAT kit

Complete Ph. Eur. approval 

While the European Pharmacopoeia (Ph. Eur 2.6.30) clearly accepts the donor-pooled PBMC of CTL-MAT as an approved method for detecting endotoxins and non-endotoxin pyrogens (NEPs), the same cannot be said about the cell-line mono-mac-6 (MM6) of the PyroMAT system. Specifically, the Ph. Eur. (2.6.8) describes the MM6 as "limited" when it comes to the detection of NEPs. As such, by the letter of the law, using the PyroMAT kit would require employing an NEP risk-assessment as you would with an endotoxin test.

Batch sizes of PyroMAT system vs. CTL-MAT kit

Keeping conditions consistent across the various release or R&D pyrogen tests carried out in an organisation is very important. Because the centerpiece of MAT is the human blood by which it simulates the human immune system response, it's very important to have access to cells from a single, large batch of donor cells. In the case of PyroMAT, you will be able to keep your conditions consistent from this perspective across 200 kits you buy while MAT BioTech currently facilitates this across 2,000 kits. This owes to our large-scale, state-of-art manufacturing site in Cleveland Ohio where the CTL-MAT kit is produced; it's where the magic happens.

Comparison

PyroMAT
system

CTL-MAT kit

Batch sizes

200 kits

2,000+ kits

Why choose
CTL-MAT vs. PyroMAT?

Assay analysis

PyroMAT ™ System

CTL-MAT
Kit

On-demand availability

Low risk of donor variation

Generalizability of results

Reproducibility of results

Limit of Detection (LoD)

Batch sizes of cell-source vials

0.05 EU/ml

0.004 EU/ml

200

2,000+

European Pharmacopoeial approval as pyrogen test

Automatic approval as endotoxin test

Automatic approval as non-endotoxin test

Learn more about MAT over a call with the scientists that commercialised it.

Wouldn't it be nice to set-up your PC with Bill Gates on the line rather than the computer store that sold it to you? Unlike the Merck and the PyroMAT system, our team comprises the very scientists that designed the CTL-MAT kit and those provided by almost every other MAT provider out there. Any questions you may have – big or small – you can be rest assured in knowing that they'll be able to answer.

"We now partner with the largest pharmaceutical manufacturers worldwide. Almost all of them also tried the PyroMAT System and all of those chose the CTL-MAT kit."

100%

conversion rate

You'll be in 

good company.

Join some of the largest pharmaceutical and medical device companies in the world who partner with us for Monocyte Activation Testing. 

Want to learn more? Let's get in touch.

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