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Viral Vector Vaccines

Viral Vaccines cGMP Manufacturing

WuXi Vaccines offers formulation development, drug product process development and GMP manufacturing / fill services for a wide variety of viral vaccines. GMP production capabilities includes formulation and fill of vials and pre-filled syringes (PFS) in fully automated, fully-programmable, gloveless and isolator-based Vanrx sterile fill systems.

DS Manufacturing

Suspension Cell Culture

 

  • Shorter production time: N-1 perfusion in wave system
  • High cell density: Intensified cell culture process
    (ATF based)
  • Mature scale up strategy: from bench scale to 200 L to 2000 L

Adherent Cell Culture

 

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

 

Robotic Aseptic Filling Isolator for Viral Vaccines in BSL-2 Facility

  • Vanrx SA25 gloveless, fully-programmable and robotic, isolator-based sterile filling system: the perfect combination for advanced aseptic processing
  • Extensive flexibility to support the complex drug filling processes of BSL-2 viral vaccines

 

For more information on our extensive formulation and Drug Product process development services, click here.

Vanrx SA25 Robotic Sterile Filling System

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 qualification and method transfer
  • GMP DS/DP release and stability testing for clinical vaccines
  • Molecules: virus vectors, viral 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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