The Rapid-Fire World of Endotoxin Testing
An evolution of microbial tools is helping us to screen faster and to reduce human error
Bacterial endotoxins, the highly toxic, heat-stable lipopolysaccharides (LPSs) that comprise the outer cell membranes of gram-negative bacteria, can create a fever-inducing response in humans. For this reason, all major compendia call for endotoxin testing to ensure that pharmaceutical products will be safe for use. Bacterial endotoxin testing has evolved over the past 90 years, and as endotoxin testing platforms have improved, the opportunities for increasing assay speed, sensitivity, and/or decreasing the cost of testing, have continued to create more effective and efficient endotoxin testing system.
Jeffrey Weber, Senior PAT Project Manager and chair of Pfizer’s RMM strategic committee, which is responsible for the assessment, deployment, and support of rapid microbial methods, will be presenting a lecture at the A3P Microbiology meeting in Tours, France on March 21. The title of his topic is “Increasing Operational Efficiencies with Rapid Endotoxin Testing Platforms.” We connected with Jeffrey a few days in advance of his talk to catch his views on cartridge technology, how rapid endotoxin testing impacts human errors and what hot trends to keep an eye on this year. Here are his responses.
What is the overall organizational impact of implementing and utilizing cartridge technology for endotoxin testing?
JW: The EndoSafe LAL cartridge has enabled streamlining of several aspects of endotoxin testing from simplified ordering of reagents (a single catalog item), decreased reagent handling and storage, and less wasted reagents. The operational improvements have led to fewer manipulations, reduced operator errors and decreased operator sample bias. Additional benefits we have seen compared to gel clot are improved data integrity, improved insights into assay performance and decreased data entry errors. The system has enabled trending of results using quantitative information from the EndoSafe system. Finally, the common platform has enabled troubleshooting and investigations to be streamlined as the assay is well characterized and the lessons from one site can quickly be applied across the network
What is the regulatory impact of utilizing cartridge technology for endotoxin testing on one’s organization?
JW: Very little. The system uses the same assay as USP <85> and EP 2.6.14 and the benefit is assay simplification and automation without the need for changing registrations.
How does rapid endotoxin testing technology impact a laboratory’s testing performance in terms of reducing human error?
JR: We have observed reductions in laboratory investigations quarterly using gel-clot to zero for one year using the EndoSafe LAL-cartridge technology. The decreased sample handling and fewer operator manipulations has essentially eliminated laboratory errors for routine samples.
What do you think will be tomorrow’s big topic around endotoxin testing (i.e. what hot trends do you see developing down the pike?)
JW: The industry will continue to improve automation of samples including automatic pH adjustments and less operator interaction with the samples.The next generation will be online endotoxin testing with sample interfaces that automatically withdraw the sample and report the results to the LIMS system.