Article: Are nitrosamines a concern for biologic manufacturers?
Posted: 30 March 2023 | SGS Health Science | No comments yet
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk. Read the article to find out more.
The discovery of nitrosamine genotoxins in several pharmaceuticals has led to monitoring and re-evaluation of manufacturing practices for those products considered at risk.
This article provides an assessment of nitrosamine contamination specifically in biologics and contrasts the potential risks between these product types.
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Analytical techniques, Biologics, Biopharmaceuticals, Bioprocessing, Chromatography, Drug Delivery Systems, Drug Development, Endotoxin, Good Manufacturing Practice (GMP), Lab Automation, Manufacturing, Regulation & Legislation, Research & Development (R&D)