CDMO focused on human health. EU GMP certification Biofabri is the ideal partner for any organization intending to advance their biologic product candidates from development scale to clinical Phase 1 to III and comercial supplies capabilities.
EXPERT IN BIOTECH MANUFACTURING
- Live & Inactivated Bacteria & Viral Vaccines
- Roller Bottles & Cell Factory
- Single-use Bioreactors
- Sterile processing systems
- Centrifugation, Ultrafiltration, Diafiltration
- Process Development/ Optimitation
- Cold chain up to -80 ºC
- cGMP preparation and control of Master and Working Seed Lots of cells, Virus and Bacteria.
- GMP Upstream & Downstream processes, based on single use equipment.
- Upstream process optimization for Virus, Bacteria and Cell cultivation.
- Downstream process optimization, with capabilities for Centrifugation, Purification and Immunopurification.
- Vaccines formulation.
- Wide capacity for aseptic filling.
- Lyophilization: Virus, Bacteria and other biological investigational medicinal products.
- Stability testing of seed lots, intermediates and finished products.
- In-use stability studies.
- Commercial prodution.
- Labeling & Packaging
- Wide capacity for physical-chemical and biological control, including sterility test.
- Implementation of methods of control of intermediate and finished product.
- Assays in animals models to BSL 3.
- Preparation of Investigation Medicinal Product Application Quality dossier for Clinical trial IMP authorization.
- Biological and sterile products release.
- Storage and Shipment.