Bio-Rad - Preparing for a Stress-free QC Audit

Lonza’s new rabbit-free rapid PyroCell MAT systems reduce time-to-results from two days to two hours

Lonza has launched two new rapid monocyte activation test (MAT) systems, the PyroCell MAT Rapid System and PyroCell MAT Human Serum (HS) Rapid System, to streamline and simplify rabbit-free pyrogen testing. The systems, which will replace Lonza’s current MAT system kit offerings, contain the new PeliKine Human IL-6 Rapid ELISA Kit that minimizes hands-on time and reduces time-to-results from two days to two hours. The new tests give pharma manufacturers easier, faster, and more efficient MAT testing options for product safety testing while helping to reduce the reliance on animals.

Historically, pyrogen testing of pharmaceuticals has relied on the Rabbit Pyrogen Test (RPT), an unsustainable method requiring significant time-to-results. Pharma manufacturers now face growing pressure to discontinue the RPT due to ethical concerns, regulatory initiatives, and directives to increase the efficiency of QC pyrogen testing programmes.

Lonza’s PyroCell MAT Rapid Systems, with the new PeliKine Human IL-6 Rapid ELISA Kit, help streamline QC testing workflows. The new ELISA kit contains pre-coated plates and an improved protocol with combined incubation steps, minimizing hands-on time and reducing time-to-results to just two hours. The new rapid ELISA kit results are comparable to the current industry standard, making switching to the new test simple for customers. Most critically, the new rapid ELISA kit has been specifically validated for use with the MAT.

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Orla Cloak, VP, head of Bioprocessing Solutions, Lonza, commented: “With the RPT set to be discontinued in Europe by 2026, and sustainability a growing focus, pharmaceutical manufacturers are looking to adopt an RPT replacement. We’ve leveraged our long collaboration with Essange Reagents, formerly Sanquin Reagents, to deliver the new PyroCell MAT Rapid Systems, offering customers two MAT solutions that are easier to execute. Transitioning to rabbit-free, sustainable pyrogen testing has never been simpler.”

Lonza will discontinue its current PyroCell MAT System and PyroCell MAT Human Serum System by early 2024.
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