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Viral Vector Vaccines

Viral Vaccine Analytical Testing

Viral Vaccine Analytical Capabilities and Capacity

  • Gene sequencing (NGS) (outsourced)
  • PCR for vector genome/GOI
Virus Count
  • qPCR or ddPCR for particle count
  • Viral particles with ELISA
  • Sterility
  • Bioburden
  • Mycoplasma
  • Endotoxin
  • Adventitious viruses (outsourced)
  • Plaque assay
  • TCID50 Infectivity
  • GOI expression
  • GOI functionality by cell-based assay
Purity and Impurity
  • Aggregation and size distribution
  • Vector protein
  • Replication competent vectors (outsourced if BSL-3 is required)
  • Process Residuals: Host cell DNA/protein/RNA, benzonase/BSA


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