Biologics Production: Impact of Degrading or Modifying Impurities Resulting from Microbial Contaminations of Non-Sterile Process Intermediates on Product Quality

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...

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