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Viral Vector Vaccines

Viral Vaccines GMP Manufacturing

WuXi Vaccines offers extensive capabilities and capacity in the development and GMP manufacturing of live-attenuated viral vaccines and viral vectored vaccines in BSL-2 facilities. GMP production capabilities include single-use bioreactors up to 500 L, oRABS and Isolator technology for fill and finish, and quality control.

DS Manufacturing

Suspension Cell Culture

 

  • Shorter production time: N-1 perfusion in the wave system
  • High cell density: Intensified cell culture process
    (ATF-based)
  • Mature scale-up strategy: From bench-scale to 200 L in place, up to 500 L

Cell Culture

 

  • Higher efficiency: Perfusion-based microcarrier cell culture in single-use bioreactors
  • Higher volumetric titer with a smaller footprint: Fixed-bed bioreactor like iCellis

Manufacturing Capacity for Viral Vaccines

Facilities CCS Unit/Batch
Liquid product, 8 hours filling		 Unit/Batch
Lyo product
DP16 2R 144,000 21,920
10R 96,000 9,490
20R 62,400 6,195
DP17 2R 240,000 300,000
10R 192,000 129,000
20R 114,000 84,000

SYNTEGON® Automatic Vial Filling Line

  • Peristaltic Pump Filling
  • Single-Use Filtration and Filling System
  • 100% or Statistic Sampling IPC
  • oRABS (DP16) and Isolator (DP17) Technology
Services
  • Analytical method transfer and method qualification
  • GM DS and DP release and stability testing
  • Modality: live-attenuated and viral vectored vaccines
Employees
  • Over 40 highly-trained QC staff
  • Over 70%  with M.S. degree or greater
Facilities
  • BSL-2
  • ~ 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)
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