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PHSS News | Open Access | Published 2 July 2026 PHSS is proud to announce bioMérieux as our first Supporting Partner This new initiative launches this month and recognises organisations that have demonstrated sustained support for PHSS and our mission to advance compliant, sustainable healthcare innovation. As an independent, not-for-profit organisation, PHSS works without commercial bias to provide trusted guidance in GMP, regulatory interpretation, and practical implement

Medicines are being developed for diseases that were previously untreatable, and new technologies such as cell and gene therapies, gene editing (ATMPs), Antibody Drug Conjugates (ADCs), and Lipid Nano Particles (LNPs) are providing new ways to target these diseases.

Endotoxin detection is essential in pharmaceutical manufacturing due to the strong pyrogenic activity of lipopolysaccharides (LPS) from Gram-negative bacteria. While the Limulus Amebocyte Lysate (LAL) assay has traditionally served as the reference method, sustainability concerns have driven the development of recombinant alternatives such as recombinant Factor C (rFC). This study compared the performance of an rFC assay with five LAL methods (three KCA and two KTA) using