A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics


16th September 2020 | 10:30 am PST, 13:30 pm EST | Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at Roche and Shabnam Solati, CEO & Co-Founder at CTL-MAT |BOOK FREE SEAT FOR THIS WEBINAR

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 Case-by-Case Assessment of Bioburden (CCAB) approach described here enables a comprehensive assessment of these risks.

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) 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). Currently Friedrich is QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at Roche. In his previous 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.

Followed by Shabnam Solati, CEO & Co-Founder at CTL-MAT

Shabnam Solati, CEO & Co-Founder, developed a Monocyte Activation Test to meet the end-to-end MAT needs of the industry, with pyrogen detection and quantification levels that are unprecedented. With the expertise of MAT and the knowledge regarding all the test’s potential abilities, Shabnam is dedicated to building the future of MAT beyond where it is today. Therefore, research, development and innovative technologies are continuous focus points at CTL-MAT.

Sponsored by CTL-MAT – The MAT Company

CTL-MAT – The MAT Company was established to serve any and all of your Monocyte Activation Test needs, offering MAT Kits, Pooled PBMC, Batch Release Testing, Product-specific Validation and Consultation Services. The MAT is the only quantitative, in-vitro, true pyrogen test – measuring endotoxins and non-endotoxin pyrogens alike. CTL-MAT’s products and services permit Ph. Eur. 2.6.30-compliant, robust and accurate detection of pyrogenic contaminants in parenteral drugs, biopharmaceuticals, cosmetics, solid medical devices and other medical products.


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