CCAB: A universal tool to address the risk of microbial impurities in parenteral drug manufacturing including ATMPs


26th January 2022 | 10:00am PDT / 6:00pm GMT | Dr Friedrich von Wintzingerode, QC Lead iNeST (individual Neoepitope Specific Therapy), Roche and Eelo Gitz, Head product development at Sanquin Reagents |BOOK FREE SEAT FOR THIS WEBINAR

For parenteral drugs such as monoclonal antibodies, injectable oligonucleotides, and RNA- or DNA-based ATMPs, filtration using pore sizes ranging between 0.02 and 0.2 µm is the method of choice to reduce bioburden and ensure terminal sterilization of the drug product. While filtration efficiently removes intact microbial cells it does not remove subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases or endoglycosidases. These microbial impurities can have a significant impact on product quality and patient safety when critical loads are exceeded during a contamination event. The CCAB approach described here enables a comprehensive assessment of these risks.

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST (individual Neoepitope Specific Therapy), Roche

Friedrich is QC Lead of the iNeST Project (individualized Neoantigen Specific Therapy) at Roche-Genentech. After studying biology with focus on Microbiology at the Technical University of Braunschweig, Germany he earned his PhD at the Institute of Microbiology and Hygiene, Charité, Berlin, Germany. He joined Roche in 2001 working as QC Manager and Senior QC Manager on various topics (environmental monitoring, cleaning analytics, microbiological IPC and analytics for release). Friedrich led several Roche-Genentech expert teams (e.g. identification, microbiological testing, endotoxin testing, and Low Endotoxin Recovery/LER) and co-chaired the PDA Low Endotoxin Recovery Task Force, which authored PDA Technical Report No 82 on LER. He is also a member of the PDA ATMP advisory

Followed by Eelo Gitz, Head of product development at Sanquin Reagents

Eelo obtained his PhD in Biomedical Sciences at the University of Utrecht (the Netherlands). After a post-doctoral study in the field of platelet biology at the University of Birmingham (the UK), Eelo joined Sanquin Reagents (Amsterdam, the Netherlands) where he is currently working as head of product development. During the last 6 years, he has been working on the development and production of Monocyte Activation Test (MAT) kits based on cryopreserved peripheral blood mononuclear cells (PBMC) and setting up an MAT Center of expertise at Sanquin.

 


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