Having recently conducted a project to implement more sustainable, reliable and efficient bacterial endotoxin testing across the global Roche corporation, those involved in the project discuss with EPR’s Hannah Balfour the key takeaways from their implementation and validation, as well as current trends in bacterial endotoxin testing.
Ensuring products are free of contaminants has and will continue to be a vital part of the process of getting life-saving therapies to patients – the risk of causing further suffering to ailing individuals is out of the question. One critical part of product release is the quantification of endotoxins from Gram-negative bacteria. Endotoxins are lipopolysaccharides present inside a bacterial cell that are released when they disintegrate. They can induce inflammation and fever in humans and, in rare cases, lead to anaphylactic shock and death.
The industry’s well established compendial methods lay a foundation for the production and release of high-quality therapeutics. Yet as such products and the sector evolve, and external pressures such as sustainability enter the equation, pharmaceutical manufacturers are now establishing alternative and rapid microbial methods (ARMMs) – the methods of the future.
Here, Dr Lindsey Silva, Director Microbiology in Analytical Sciences at Genentech, Carmen Marín Delgado de Robles, Quality Control Scientist Microbiology at Roche Basel-Kaiseraugst, Dr Viviane Grunert da Fonseca, non-clinical statistician and member of the Manufacturing Science and Technology Department at Roche Diagnostics GmbH in Penzberg and Evelyn Der, Global Lead for the rFC implementation project and the Analytical Technology Center Lead in Microbiology within Roche’s Global QC, discuss the current trends in bacterial endotoxin testing and comment on their recent work to ensure the company’s global testing strategy aligns with its sustainability-driven culture.
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