Biologics Production: Impact of Degrading or Modifying Impurities Resulting from Microbial Contaminations of Non-Sterile Process Intermediates on Product Quality
Posted on March 13, 2019
Friedrich von Wintzingerode, PhD, Senior Manager, Global QC Microbiology
Markus Haberger, Senior Scientist Pharma Technical Development
Andreas Adler, Senior Associate Pharma Technical Development
Anna-Katharina Heidenreich, Senior Associate Pharma Technical Development
Christian John, Senior Specialist, Pharma Technical Quality
Ingo Lindner, PhD, Senior Scientist Pharma Technical Development
Roche-Genentech
Elke Hammer, PhD, Senior scientist and group leader proteomics
University Greifswald, Department Functional Genomics
Prof Uwe Völker, Head of Department Functional Genomics
University Greifswald
Abstract Production of Biologics is susceptible to microbial contamination. Bioburden contaminations of non-sterile process intermediates represent a risk to patient safety and product quality. Even after bioburden removal by filtration, and even if both Drug Substance and Drug Product specification...
To read the full article and other articles in this issue, please register for a free account or log in.
We will not sell or give your information to a third party. See our Privacy Policy
Related Topics and Keywords
bacterial, Bioburden contaminations, cell wall, degrading or modifying microbial impurities, flagellin, fungal DNA, lipopeptides, lipoproteins, Microbial Contaminations, PAMPs, polysaccharides
Subscribe to our FREE newsletter and WEBINAR UPDATES
We will not sell or give your information to a third party. See our Privacy Policy
