DEVELOPMENT, PHASE I-III AND COMERCIAL MANUFACTURING

END-TO-END CDMO

  • Live & Inactivated Bacteria & Viral Vaccines up to BSL-2
  • Sterile 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-non-sterility, Chemical-Physical and Biological
  • Labelling & Packaging
  • DS & DP release
  • Storage: (+2-8ºC), (-30ºC), (-80ºC)

cGMP Production capabilities

  • cGMP preparation and control of Master and Working Seed Lots of cells, Virus and Bacteria
  • Roller Bottles, Cell Factory & Wave bioreactor
  • Single use bioreactors: 50L + 2x250L + 2x2000L
  • Stainless Steel bioreactors: 50L +250L+ 2x2000L
  • Single use blending mixers: 2 x 3000L
  • Stainless steel vessels: 4x6000L
  • State-of the art purification processes: Chromatography (ÄKTA ready), Centrifugation, Ultrafiltration, Diafiltration

cGMP fill & finish capabilities

  • Liquid and Lyophilised products up to BSL-2
  • 4 filling machines
  • 6000 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

For more details

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