Case-by-Case Assessment of Bioburden (CCAB): A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics

09th April 2019 | 10:00 am CEST | Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche |BOOK FREE SEAT

Large-scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety. Even after bioburden removal by 0.2 µm filtration subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases or endoglycosidases remain in the product. Those microbial components potentially lead to toxic, allergic or inflammatory responses in humans or product degradation or modification. The CCAB approach described here enables a comprehensive assessment of these risks.

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

Friedrich studied biology with a 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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