New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical Manufacturing Process


09th April 2019 | 10:00 am CEST | Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche and Mathilde Arnault, Research Scientist, BioMonitoring R&D, Merck KGaA, Darmstadt, Germany |WATCH FOR FREE

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 at 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.

 

Sponsored by Merck Group

Merck KGaA, Darmstadt, Germany – A Leader in life science. Our purpose is to solve the toughest problems in life science by collaborating with the global scientific community – and through that, we aim to accelerate access to better health for people everywhere. We provide scientists and engineers with best-in-class lab materials, technologies and services. We offer more than a complete range of high quality microbiology testing solutions for the pharmaceutical, cosmetics, municipal water, beverages and food industries.

Testing for pyrogens and endotoxins is a critical step in ensuring the safety of parenteral pharmaceutical products and medical devices. The Monocyte Activation Test (MAT) can detect both endotoxin and non-endotoxin pyrogens in one test. Supported by many regulatory bodies, the robust MAT assay produces sensitive results based on the human reaction. With our new PyroMAT™ system, we provide a robust, reliable and standardized method for pyrogen detection.

Followed by Monocyte Activation Test: a powerful tool to assess pyrogenic risk in pharmaceutical process

Microbial risk in pharmaceutical process is not limited to viable microorganisms. Subcellular components from microorganisms remaining from the production process can be source of pyrogens, compromising product quality and patient safety as these substances are not eliminated by classical filtration or sterilization steps. According to the European Pharmacopeia, chapter 5.1.10, a risk assessment has to be performed to justify the method to be used for pyrogen detection: bacterial endotoxin testing is not sufficient if the presence of non-endotoxin pyrogens in the production process cannot be excluded. The Monocyte Activation Test (MAT) can detect both endotoxin and non-endotoxin pyrogens in one test. Supported by many regulatory bodies, the robust MAT assay provides sensitive results based on the human immune reaction and can be a powerful tool in this risk assessment. With our new PyroMAT™ system, we provide a robust, reliable and standardized method for pyrogen detection.

Presented by Mathilde Arnault, Research Scientist, BioMonitoring R&D, Merck KGaA, Darmstadt, Germany

Mathilde Arnault hold an engineer master degree in biotechnology from INSA Lyon, France. Since 2013, she is working as a research scientist in the BioMonitoring R&D group. Her main focus was the evaluation of new microbial detection technologies in order to develop innovative solutions for QC laboratories of pharmaceutical and food and beverage industries. Mathilde has recently led the development of a pyrogen detection solution based on a monocytic cell line.


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