31st August 2021 Content supplied by: Merck
The Upcoming End of the Rabbit Pyrogen Test and its Replacement by the Monocyte Activation Test
Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs. Today, the two main test methods in use are the bacterial endotoxin test (or LAL test) and the rabbit pyrogen test (RPT).
The monocyte activation test (MAT), the only in vitro pyrogen test, uses human monocytic cells to mimic the human reaction to pyrogens. This test is a robust solution to avoid the use of animals for pyrogen testing in pharmaceutical quality control.
Yet, the MAT remains little known because, until recently, the position of regulatory bodies was not clear enough to encourage end users to implement a new test method. However, the MAT’s adoption rate is slowly growing since it has been described as a compendial method in the European Pharmacopeia since 2010 (chapter 2.6.30). Recently, several tests have been commercialized, allowing an easy adoption and use in the lab.
To better establish this test method as a replacement of the RPT, the European Pharmacopoeia Commission recently made the decision to revise the parts of 59 Ph. Eur. that refer to the RPT. This decision is in accordance with the 3Rs principle, considering that an alternative in vitro method for pyrogen detection is available.
The commission is now actively encouraging users to seek alternatives, the best option being the MAT. Click here to view the announcement.
The PyroMAT® System is a MAT solution that uses a monocytic cell line for the detection of pyrogens. This cell line has demonstrated its ability to detect a wide range of pyrogens with high sensitivity.
Follow the latest regulatory recommendations, and start using our ready-to-use in vitro test kit for pyrogen detection, the PyroMAT® system. It is a reliable and sensitive solution to replace the rabbit pyrogen test for a safe release of parenteral drugs.
To learn more about our MAT solutions, visit our webpage.
Date Published: 31st August 2021
Source article link: View