Walkersville, MD (USA), 21 May 2015 – Lonza has announced that two more speakers have joined the expert lineup that will present at its 1st Global Endotoxin Testing Summit (1-3 June 2015, Annapolis, MD, and Pickering Beach, DE). Dr. Michael Dawson from the Associates of Cape Cod, Inc. (ACC), and Dr. Ingo Spreitzer from the Paul Ehrlich Institute will give educational presentations as part of the three-day event, which will focus on the evolution of endotoxin testing, the development of practical solutions for Low Endotoxin Recovery (LER) and new opportunities for process optimization.
The two new speakers join an esteemed list of industry thought leaders attending and presenting at the 1st Global Endotoxin Testing Summit. Dr. Dawson, Director of Regulatory Affairs at ACC, has many years of experience in the endotoxin detection industry and speaks frequently on endotoxin-related issues. He has also directed and participated in many courses on endotoxin testing and the regulatory aspects of its application in health-care industries.
Dr. Spreitzer is the Deputy Head of Department at the Paul Ehrlich Institute in Germany. He is also Chair of the Working Party for the Bacterial Endotoxin Test, which is being undertaken as part of the European Directorate for the Quality of Medicines and HealthCare (EDQM). In November 2014 his group published new policy guidelines for the use of bacterial endotoxin tests in a pharmaceutical setting as part of updating the current version of the European Pharmacopoeia.
Alan Baines, Head of Strategic Projects at Lonza Bioscience Solutions, said: "The phenomenon of LER has recently been highlighted by the US Food and Drug Administration (FDA) as a significant problem for the manufacturers of biopharmaceuticals containing citrate, polysorbate and phosphate components. As the accurate measurement of endotoxin load is an integral part of the entire manufacturing process, as well as final product release, a solution to address the challenge that LER represents is urgently needed."
He added: "The 1st Global Endotoxin Summit will provide a unique opportunity for endotoxin-testing experts, manufacturers, lysate vendors and conservationists to discuss these issues, with a view to gaining a greater understanding of LER, as well as the ongoing goal to develop, optimize and adopt alternative test methods that do not rely on horseshoe crab blood."
One of the other key highlights that distinguish the summit from similar endotoxin testing meetings is that attendees will have the opportunity to visit a horseshoe crab sanctuary beach during the peak of spawning season. While there, attendees will work with the Ecological Research & Development Group (ERDG) team, led by Glenn Gauvry, to "flip" and save stranded crabs, thus providing the chance to contribute to the conservation efforts put in place to protect this important species.