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.
-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.
https://biofabri.es/es/
