Viral Vector Vaccines

Viral Vaccine Analytical Testing

Viral Vaccine Analytical Capabilities and Capacity

Identity	Gene sequencing (NGS) (outsourced) PCR for vector genome/GOI
Virus Count	qPCR or ddPCR for particle count Viral particles with ELISA
Safety	Sterility Bioburden Mycoplasma Endotoxin Adventitious viruses (outsourced)
Titer/Potency	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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