A study was performed to show whether the PyroMAT^® System, a monocyte activation test (MAT) that uses cryo-preserved Mono-Mac-6 (MM6) human monocytic cells as its source of monocytes, can detect both endotoxin and non-endotoxin pyrogen in a meningococcal vaccine preparation.

The MAT is the human in vitro alternative to the rabbit pyrogen test, allowing the detection of the full range of pyrogens, including endotoxins and non-endotoxin pyrogens (NEPs). The meningococcal group C conjugate vaccine used in the study was a liquid preparation of purified capsular polysaccharide derived from Neisseria meningitidis Group C, linked to tetanus toxoid as a carrier and adsorbed to aluminum hydroxide as adjuvant.

The data show that the PyroMAT^® system is suitable for detecting both endotoxin and non-endotoxin pyrogenic contaminations in preparations of the vaccine. With respect to its pyrogen spectrum, it is therefore similar to the rabbit pyrogen test (RPT) which, however, yields purely qualitative results. The pyrogen spectra of the RPT and the PyroMAT^® system exceed that of the bacterial endotoxin test (BET), also known as the Limulus Amebocyte Lysate (LAL) test, which does not detect NEPs. With the higher informational value of its results, the PyroMAT^® system can point to issues early on that could otherwise come to light at a later date, potentially causing disruption and loss of time.

To read the details of the study, download the application note “Detection of pyrogens in a vaccine preparation with the PyroMAT^® System”