PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry

03rd May 2019 | 10:00 am CET | Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche |WATCH FOR FREE

Since first reported by Chen and Vinther in 2013, the phenomenon known as low endotoxin recovery (LER) has been broadly observed in certain matrices commonly used for biologic formulations and certain therapeutic proteins. LER is defined as the inability to recover >50% activity over time when endotoxin is added to an undiluted product. LER is a temperature and time dependent process, which usually does not occur immediately but after several hours to several days. Compendial LAL method qualification (Bacterial Endotoxin Test = BET per USP <85>/EP 2.6.14/JP 4.01) does not include defined hold time conditions, which may explain why LER has not been detected by following compendial BET guidance. Because of the potential impact to patient safety and the complex nature of the LER issue, the Parenteral Drug Association (PDA) published a Technical Report (TR) on LER. This TR was authored by subject matter experts from academia, U.S. FDA, biopharmaceutical companies, and reagent suppliers/testing contractors. The PDA Technical Report on Low Endotoxin Recovery provides a science-based and data-driven strategy in dealing with the LER phenomenon. The author of this article, who acted as co-lead of the TR authoring team, provides first hand information that allows companies to develop product specific solutions to the LER problem.

Presented by Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche

Friedrich studied biology with the focus on Microbiology at the Technical University of Braunschweig, Germany.

Diploma at German Strain Culture Collection (DSMZ), Braunschweig, Germany. Degree at Institute of Microbiology and Hygiene, Charité, Berlin, Germany. Since 2001 employed at Roche Diagnostics (Pharma Technical Operations) working as Micro lab manager on various topics (environmental monitoring, cleaning analytics, microbiological IPC and analytics for release).

In his role as Senior Manager Microbiology Friedrich led several Roche/Genentech Micro expert teams (e.g. identification, microbiological testing).

He is Head of Roche/Genentech global Endotoxin Expert Group since 2013 and Roche/Genentech global SME on microbial product contaminations.

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