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.