CCAB: Addressing the risk of microbial impurities in Biologics and certain Advanced Therapy Medicinal Products (ATMPs)

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 Nahuel Paolini, PhD, at Sanquin Reagents,

Nahuel obtained his PhD in Biomedical Sciences at Sanquin and the University of Amsterdam (the Netherlands). As an R&D scientist at Immunetune, he worked on DNA cancer vaccines. Nahuel joined Sanquin Reagents (Amsterdam, the Netherlands) where he is currently working as scientist product development. During the last 2 years, he has been working on the development and production of Monocyte Activation Test (MAT) kits, based on cryopreserved peripheral blood mononuclear cells (PBMC).
About Sanquin Reagents
Sanquin Reagents. B.V. (Reagents) is one of the divisions within the Sanquin Health Solutions Group B.V. (SHSG). At Reagents, around 100 employees work on the development, production and marketing of blood grouping and immune reagents, kits and devices. These products are used for in vitro diagnostics and research purposes and are sold via a global network of distributors. We have strong collaborations with other divisions of SHSG and other institutes to achieve our goals and combine our expertise. One of these collaborations has resulted in the development of the Monocyte Activation Test (MAT), an in vitro-based alternative assay for the Rabbit Pyrogen Test (RPT)  to detect pyrogenic activity in pharmaceutical products. Within our MAT Center of Expertise,, we conduct MAT-related research, develop and produce MAT test kits (ISO 13485 certified) and provide MAT test services (GMP and ISO 15189 certified). To guarantee worldwide availability we collaborate with our partner Lonza for global distribution of the MAT kits.
Sponsored by  Lonza

About Lonza
Lonza delivers technologies to enable a healthier world. We are a preferred global partner to the pharmaceutical, biotech, nutrition and specialty ingredients markets. Lonza offers a complete selection of limulus amebocyte lysate (LAL)-based and sustainable endotoxin and pyrogen testing solutions for pharmaceutical and biotechnology quality control (QC) testing laboratories. Improve laboratory efficiencies with the PyroTec™ PRO System, powered by WinKQCL® Software, that automates the manual tasks associated with endotoxin testing. In addition to traditional LAL-based endotoxin kits, offered in a variety of sizes and sensitivities, our PyroGene® rFC Assay and PyroCell® Monocyte Activation Assay provide animal-free testing options. We also offer the MODA® Paperless Solution for automated environmental, utility and product monitoring and analytics. Our solutions improve life quality by preventing illness, enabling healthier lifestyles and supporting a safe environment by combining technological insight, with world-class manufacturing, scientific expertise and process excellence.