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Does Your Manufacturing Process Meet the Regulatory Requirements?

There has been an increase in pressure by regulatory authorities in Europe to replace the rabbit pyrogen test (RPT) with in vitro alternatives such as the compendial Limulus Amebocyte Lysate (LAL) test or the alternative Monocyte Activation Test (MAT). On the other hand, the FDA is also requesting companies to provide supporting data to the LAL test where low endotoxin recovery (LER) is questioned on biological drug products. GMP regulators in Europe are pressuring companies to provide robust justification to continue using the RPT as a release test where in vitro alternatives exist. In Germany, authorities are not renewing RPT licenses past June 2019, with others to follow suit.

Certain formulations and product types (biological drug products) have been reported to interfere with endotoxin recovery in the USP LAL test methods over time. Therefore, the FDA is instructing new clients to assess the effect of hold time on endotoxin recovery by spiking a known amount of standard endotoxin (CSE or RSE) into undiluted drug product, and then testing for recoverable endotoxin over time. These LER study reports are expected to be included in the company’s BLA.

At Charles River, we are set up to meet all your pyrogenicity testing needs, as we provide RPT, LAL, and MAT services. We are positioned to perform comparison studies between the three different methods along with LER spiking studies. We also offer several highly flexible rapid endotoxin testing platforms to meet the needs of a variety of sample throughput and different lab sizes. To learn more about these offerings, please contact us at [email protected].