Alternative analytical solutions for endotoxin and pyrogen testing
Sara Hully
Paula Paci
Fabian Vandermeers
Géry Van Vyncht
Arnaud Delobel

At the cutting edge of analytical sciences, Quality Assistance is constantly investing in the latest technologies and equipment to provide the pharmaceutical industry with up-to-date services required by regulatory authorities and product evolution

For years, Quality Assistance has performed LAL tests for QC testing on various (bio)pharma products such as recombinant proteins, mAbs, small molecules, peptides as well as nanoparticle formulations.

To complete our analytical panel and to be in line with new guidelines for endotoxin testing, we have implemented the new PyroGene® recombinant factor C (rFC) assay (commercial kit from Lonza) in 2022 to avoid the sourcing of LAL lysate from animals. This specific, sustainable, and simpler end-point fluorescent assay, included in Ph. Eur. 2.6.32 since 2021, is now available in a GMP environment at Quality Assistance. It can be used for QC testing in Europe after product-specific verification, and yet still requires complete method validation according to USP <1225> for the US market.

In the “3R” perspective and in preparation for the eventual removal of RPT from pharmacopeias for the testing of pyrogens (endotoxins and NEPs), we have also implemented the Monocyte Activation Test (MAT), an in vitro cell-based alternative assay, as described in Ph. Eur. 2.6.30. Being compendial in Europe, the MAT can be also used for routine QC testing after product-specific validation. However, it still requires validation in accordance with USP <1225> if the product targets the US market as MAT is still under regulatory assessment by USP. 

 

More information on the analytical validation work performed at Quality Assistance may be found in the
our dedicated application note “Validation of a Monocyte Activation test (MAT) using the PyroMAT™ kit”

Application Note_MAT

 

As a leading European Contract Research Organisation at the cutting edge of analytical challenges, we are truly committed to providing sustainable analytical solutions. We not only comply to the “3R” principle, but we act proactively to go the extra mile in terms of sustainability. With this in mind, and in accordance with the regulatory evolution (i.e., General notice 6.30, USP draft <86>), the evaluation of recombinant cascade reagents will be assessed and investigated as part of our R&D and Innovation portfolio for 2024. Providing alternative solutions for endotoxin detection at Quality Assistance demonstrates our commitment to providing the highest quality services in a responsible and ethical manner.