pharmaasiaApril 10, 2017
Lonza held its second Global Endotoxin Testing Summit in May 2016 – a unique forum for sharing innovative ideas and thoughts on current and future practice. Delegates from across the global bacterial endotoxin testing (BET) community once again met in Annapolis, MD, USA to discuss the most pressing issues affecting the field. It is a particularly dynamic time for the industry, with a number of challenges to be overcome. Furthermore, in many cases, there is no obvious, single way forward. This year’s summit touched upon a wide variety of such topics, including the ongoing search for the best possible testing standards, the need for enhanced efficiency and predictability across test sites via more standardized methods, and the growing role of automated lab systems in improving test reproducibility and throughput. There was also an update from leading experts on our growing understanding of low endotoxin recovery (LER), including exactly when and how the phenomenon is likely to occur, as well as an active discussion around the best sample preparation methods currently available to overcome its effects. Finally, a trip to Pickering Beach (DE, USA) and a session with Glenn Gauvry, founder of the Ecological Research & Development Group (ERDG), further reminded all the attendees of how important it is to responsibly manage the conservation of horseshoe crabs. As if to mirror this sentiment, a presentation from Jay Bolden of Eli Lilly and Company provided compelling evidence that the recombinant Factor C (rFC) assay is a sustainable and viable test method that, in many cases, can replace the need to use traditional Limulus Amebocyte Lysate (LAL) assays as the test-of-choice in pharmaceutical quality control.
The 3rd annual Global Endotoxin Testing Summit brings together QC directors, lab managers, key opinion leaders, users and regulators to discuss current issues within the endotoxin detection industry. This provides the opportunity to:
Hot topics for discussion include endotoxin testing basics, regulatory guidance updates, data integrity and, of course, low endotoxin recovery. An event highlight will be a visit to a Horseshoe Crab Sanctuary Beach to save crabs that have been stranded on shore. In collaboration with the Ecological Research and Development Group, a non-profit wildlife conservation organization whose primary focus is the conservation of the world’s four horseshoe crab species, participants will have the chance to meet and learn from the ancient species so important to our industry.
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