BACCINEX SA

Manufacturing

Manufacturing

Baccinex owns the required equipment and has developed a cutting-edge know-how in order to fit onto each process and to manufacture in the best conditions for both clinical trials materials (Investigational medicinal products (IMP) or non-IMP for Phase I to III) and commercial batches.We can manufacture sterile products (eg : parenteral, ophthalmic, auricular etc.) and have developed special competencies in aseptic fill/finish and lyophilisation in vials and ampoules. Our cleanrooms allow us to provide clients with a wide range of sterile manufacturing services (by aseptic processing or terminal sterilization).Formulation of bulk products are performed in a grade C environment and the solution is then transferred to a grade A and B clean room for sterile filtration and aseptic filling. Pre-production activities (washing, depyrogenation of vials, preparation of material…) and post-production (cleaning…) are carried out in a grade C environment.

Material is sterilized and introduced in grade A zone through an autoclave and a decontamination enclosure. Two Bausch Advanced Technology automatic filling machines are settled in grade A area and enable aseptic filling of vials (from DIN 2R to DIN 20R) and ampoules (from 1ml to 5 ml). Bigger vials until 100ml  or custom size vials can be filled with a manual filling machine. All product contact components are exclusively disposable or dedicated that allows working with a wide range of different products (small molecules, peptides…)

Classified facilities and production equipment are periodically requalified according to GMP.