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 Bacteria & 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
