DEVELOPMENT, PHASE I-III AND COMERCIAL MANUFACTURING
BIOFABRI is a CDMO, focused on human health, which holds EU GMP certification. Biofabri is an ideal partner for any organization intending to advance their biologic product candidates from development scale to clinical Phase I to III and commercial supply.
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
