DEVELOPMENT, PHASE I-III AND COMERCIAL MANUFACTURING

END-TO-END CDMO

  • Bacterial & Viral Vaccines up to BSL-2
  • Aseptic processing systems
  • Process Development/Optimisation
  • Scale-up and cGMP manufacturing
  • Aseptic filling into vials
  • Lyophilization (clinical trial material and large scale)
  • Quality control testing: Microbiological: Sterility and non-sterility, Chemical, Physical and Biological
  • Labelling & Packaging
  • DS & DP release
  • Storage: (+2-8°C), (-20°C), (-30°C), (-80°C)

cGMP PRODUCTION CAPABILITIES

  • cGMP preparation and control of Master and Working Seed banks of cells, Virus and Bacteria
  • Roller Bottles, Cell Factory & Wave bioreactor
  • Single use bioreactors: 50L + 2 × 250L + 2 × 2,000L
  • Stainless Steel bioreactors: 50L + 250L + 2 × 2,000L
  • Single use blending mixers: 2 × 3,000L
  • Stainless steel vessels: 4 × 6,000L
  • State-of the art purification processes: Chromatography (ÄKTA ready), Centrifugation, Ultrafiltration, Diafiltration, Tangential flow Filtration

cGMP FILL & FINISH CAPABILITIES

  • Liquid and Lyophilised products up to BSL-2
  • 4 filling machines: 6,000 vials/hour – 2 × 12,000 vials/hour – 24,000 vials/hour
  • 2 Freeze Dryer: up to 24,000 vials per run, and up to 180,000 – 200,000 vials per run
  • Component size: 2R-10R-20R
  • Manual & automatic visual inspection
  • Labelling & Packaging

COVID-19