CDMO BIOTECH
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
- Chromatography
- Process Development/ Optimitation
- Storage
- 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.
