A growing list of experts from the global bacterial endotoxin testing community has signed up to join the speaker panel at Lonza’s 3rd Global Endotoxin Testing Summit.
The summit provides a forum to share ideas and thoughts on current and future practices.
Speakers from across the globe will discuss the importance of endotoxin testing in clinical and pharmaceutical applications in fast-growing, emerging countries.
The summit will also cover advances in endotoxin detection for novel technologies, like nanomaterials and newly popularised gene and viral therapies.
Jack Levin, pioneer of the LAL industry and Professor of Laboratory Medicine at the University of California School of Medicine (San Francisco, California, USA), has joined the list of speakers.
Other speakers
James Cooper
Additionally, James Cooper, founder of Endosafe, will talk about the role of the LAL industry in horseshoe crab conservation.
Cooper completed his thesis project under Levin at Johns Hopkins University in 1971, which led to the application of the bacterial endotoxin test (BET) for parenteral products.
Johannes Reich
Returning to the speaker line-up is Johannes Reich, of Microcoat Biotechnologie, to give an update on his experiences with endotoxin testing from the contact laboratory perspective, particularly in regard to low endotoxin recovery (LER) demasking studies.
Reich will join several other renowned scientists, users, suppliers and regulators to discuss the latest response from the US Food and Drug Administration regarding low endotoxin recovery and its potential biological effects.
Constanze Reinhard
Constanze Reinhard, Head of Quality Control Microbiology for Lonza’s Drug Customer Manufacturing Services Division in Visp (CH), will present case studies detailing her laboratory’s experience with conducting LER product hold-time studies.
As a member of the BioPhorum Operations Group (BPOG) LER task force, Reinhard’s lab has performed several LER-related studies on active drug products and substances.
Reinhard said: “As a custom manufacturer, we are in the lucky position of supporting many diverse projects and therefore are able to investigate protein molecules ranging from antibodies toantibody-fragmentsand antibody-drug conjugates, as well as growth factors, vaccines and enzymes.”
“During the last five years, we have built a broad knowledge base on the challenging topic of LER, endotoxin-masking by proteins; and more recently, LER-demasking, which I will be presenting at the Lonza Endotoxin Testing Summit.”
The Global Endotoxin Testing Summit will take place 5–7 June 2017, in Annapolis, Maryland and Pickering Beach, Delaware, both in the USA.
