Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
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 piece provides an assessment of nitrosamine contamination specifically in biologics and contrasts the potential risks between these product types.
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Article 6: Are nitrosamines a concern for biologic manufacturers?
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Topics
- AI, analytics and decision support
- Analytical and bioanalysis
- Bioprocessing and biomanufacturing
- Chromatography and separations
- Controlled release and advanced delivery
- Drug Development
- Endotoxin
- Formulation and drug delivery
- GMP and quality management systems (QMS)
- Quality, microbiology and contamination control
- Regulation and compliance
- SGS Life Sciences
- Upstream processing
