Mammalia production

Aseptic fill & finish

 

The last and the most GMP-critical manufacturing step: aseptic filling.

Biovian has expertise in very complex dosing requirements and aseptic processes. Biovan offers full service from fill and finish to labelling and QP-release of Drug Products for clinical trial purposes.

 


  • Dosing range 0,1 ml – 100 ml
  • Vials sizes from 1 ml to 100 ml
  • Bulk volumes up to 100 Liters
  • Batch size range from 50 to 10 000 vials
  • Lyophilisation in proprietary sterile bulk trays or in disposable trays
  • Two separate filling rooms equipped with fully disposable product contact parts
  • Filling environments applicable for hazardous molecules GMO II, BSL 3, high potent molecules
  • In house safety testing including sterility testing.