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Virus Analytical Testing

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
Location
  • Building #10 (BSL-2 lab)
Services
  • Analytical method qualification and method transfer
  • GMP DS/DP release and stability testing for clinical products
  • Molecules: virus vectors, viral vaccines
Employees
  • About 40 highly capable QC staff
  • Over 70%  with M.S. degree or greater
Facilities
  • ~ 190 m2 for Bioassay lab (~ 2,050 sq ft )
  • ~ 250 m2 for Physicochemistry and Compendial (~2,700 sq ft )
  • ~ 240 m2 for Biochemistry lab (~2,600 sq ft )
  • ~ 270 m2 for Microbiology  lab (~2,900 sq ft )
  • ~ 200 m2 for Sample, RS and Stability room (~2,200 sq ft)