Biosafety Testing For Biopharmaceuticals
Bioanalytical & Data
Information
Testing for safety/identity/residual impurities from:
- Cell banks
- Control cells
- Virus seed/bank
- Viral bulk harvest
- Drug Substance
- Raw materials (viral safety)
Assays & Studies:
• qPCR assays
• DNA sequencing (transgenes, vectors, plasmids)
• Identity
• Electron microscopy studies
• Adventitious agent detection
• Retrovirus detection
• Residual cell culture impurities
• Genetic Stability
• Microbial contaminants
• Biosafety consultancy services