25th April 2017 Content supplied by: Lonza Pharma&Biotech – Bioscience Solutions
Lonza Unveils Agenda for 3rd Annual Global Endotoxin Testing Summit
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 (5-7 June 2017, Annapolis, MD, and Pickering Beach, DE, USA).
The summit provides a forum to share ideas and thoughts on current and future practices. Dr. Jack Levin, pioneer of the LAL industry and Professor of Laboratory Medicine at the University of California School of Medicine, San Francisco, CA (USA) has joined the list of esteemed speakers. Additionally, Dr. James F. Cooper, founder of Endosafe, will talk about the role of the LAL industry in horseshoe crab conservation. Dr. Cooper completed his thesis project under Dr. Levin at Johns Hopkins University in 1971, which led to the application of the bacterial endotoxin test (BET) for parenteral products.
Returning to the speaker line-up is Dr. Johannes Reich, of Microcoat Biotechnologie GmbH, to give an update on his experiences with endotoxin testing from the contact laboratory perspective, particularly in regard to LER demasking studies. Dr. Reich will join several other renowned scientists, users, suppliers and regulators to discuss the latest response from the U.S. Food and Drug Administration regarding low endotoxin recovery and its potential biological effects.
Dr. 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 low endotoxin recovery (LER) product hold-time studies. As a member of the BioPhorum Operations Group (BPOG) LER task force, Dr. Reinhard’s lab has performed several LER-related studies on active drug products and substances.
Dr. Reinhard explained, “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 to antibody-fragments and antibody-drug conjugates, as well as growth factors, vaccines and enzymes. Furthermore, we benefit from the experience our customers have had with the authorities, which gives us unique perspectives. Over the last 5 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.”
For the 3rd Global Endotoxin Testing Summit, 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 popularized gene and viral therapies.
For more information about Lonza’s 3rd Global Endotoxin Testing Summit please visit: www.lonza.com/endosummit
Date Published: 25th April 2017
Source article link: View
White Paper: Low Endotoxin Recovery
Data Integrity for Endotoxin Testing –