Lonza to phase out traditional endotoxin testing LAL and TAL assay reader for new tech

Published: 9-Aug-2023

The company has launched the Nebula Absorbance Reader that is a technologically advanced, high-performance replacement reader, which delivers results comparable to those typically found with the traditional method and will facilitate the smooth continuation of current pyrogen and endotoxin testing programmes

Lonza has launched the Nebula Absorbance Reader, a new absorbance microplate reader which joins the company’s portfolio of optimised instruments for streamlined endotoxin and pyrogen testing.

Pharmaceutical quality control (QC) laboratories worldwide rely on the traditional absorbance-based Limulus amebocyte lysate (LAL) and Tachypleus amebocyte lysate (TAL) assays to assure the safety of raw materials in-process samples and manufactured products. However, the industry-standard absorbance reader for these assays — the ELx808 Absorbance Microplate Reader (ELx808) — will no longer be sold by Lonza from late 2023.

This launch will allow customers to confidently continue endotoxin workflows in the same smooth and streamlined way they are used to, with the support of new and improved testing functionality

- Orla Cloak, Vice President, Head of Bioprocessing, Lonza

The Nebula Absorbance Reader represents a technologically advanced, high-performance replacement reader, which delivers results comparable to those typically found with ELx808 and will facilitate the smooth continuation of current pyrogen and endotoxin testing programmes.

Similar to the Nebula Multimode Reader, the Nebula Absorbance Reader is designed for use alongside Lonza reagents. It is optimised to work with, and meet all the specifications of, Lonza’s absorbance-based endotoxin assays such as the Lonza PYROGENT 5000 Turbidimetric and Kinetic-QCL Chromogenic Endotoxin Assays. The new reader also supports the readout for monocyte activation tests (MAT) such as Lonza’s PyroCell MAT System.

The Nebula Absorbance Reader provides QC labs with new and improved functionality. It features high-performance optics and monochromator-based wavelength selection to enable precise and accurate measurements of endotoxin levels. Its compact design requires minimal laboratory space and allows for workflow flexibility.

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The reader is fully integrated with the latest version of Lonza’s WinKQCL Endotoxin Detection and Analysis Software (v6.4), enabling users to meet the latest data integrity requirements. This reduces training burdens by removing the need for existing WinKQCL Software users to learn new software in order to use the new reader. In addition, the Nebula Absorbance Reader is similar in design and build to the Nebula Multimode Reader – using the same user manual, service tools, and similar qualification procedures – which simplifies system maintenance.

Orla Cloak, Vice President, Head of Bioprocessing, Lonza, said: “As we developed the new Nebula Absorbance Reader, we focused on optimising functionality to enable it to provide the very best results for our customers. QC teams can now access a thoroughly tested absorbance reader, specifically optimised for use with Lonza reagents and fully integrated with our WinKQCL Software. This launch will allow customers to confidently continue endotoxin workflows in the same smooth and streamlined way they are used to, with the support of new and improved testing functionality.”

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