We manufacture batches for the different phases of pharmaceutical development, from manufacturing under non-GMP conditions (first stage of scale-up under industrial conditions, preparation of material for preclinical studies, stability studies, etc.) to GMP manufacturing for clinical needs.
Baccinex specializes in two distinct dosage forms: liquid products aseptically filled and lyophilized products, both filled in vials.
Preparatory activities (washing, depyrogenation of vials, preparation of equipment) as well as for the formulation stages that are performed in a grade C area.
Then product is transferred to class A in B clean room environment for sterile filtration, aseptic filling and crimping.
The lyophilizer has a surface area of 3.5m2 divided into 5 shelves with a condenser of 45 kg ice capacity.