Analysis of Process-Related Impurities and Contaminants

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• Protein / Peptide Analysis
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  • Impurities and Contaminants
  • Product-Related Impurities and Degradants
  • Process-Related Impurities and Contaminants
  
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Analysis of Process-Related Impurities and Contaminants in Biotech or Biological Products

At SGS M-Scan process-related impurities and contaminants are isolated and analysed using a combination of analytical techniques such as:

• Thermal Desorption GC-MS 
• Headspace GC-MS 
• GC-MS
• EGA-MS
• FAB-MS
• MALDI-TOF MS
• TOC
• LC-MS
• LC-MS/MS

Analysis of cell substrate-derived impurities and contaminants

Cell substrate-derived impurities include host cell proteins and host cell DNA. Please contact us to discuss options.

Analysis of cell culture-derived impurities and contaminants

At SGS M-Scan, we have experience in analysing cell culture-derived impurities and contaminants. Examples include, but are not limited to, antibiotics (e.g. Kanamycin), inducers (e.g. IPTG), media components, etc.

Analysis of downstream-derived impurities and contaminants

Downstream-derived impurities and contaminants include, but are not limited to, enzymes, residual solvents, leachables and detergents (e.g. PEG, TWEEN). SGS M-Scan are experienced in both routine analysis and “trouble-shooting.”