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.

Maximum batch production capacity per dosage form is summarized in the table below:

Dosage form LIQUID FREEZE-DRIED
VIALS
Type Maximum batch size
DIN 2R 12000 11500
DIN 6R 7000 6200
DIN 10R 6500 5000
DIN 15R 6500 5000
DIN 20R 4000 3000
50 ml 1250 1250
100ml 1250 1250
AMPOULES
Type Maximum batch size
1 ml 25000 25000
2 ml 25000 25000
5 ml 25000 13500

There is no minimum batch size: we specialize in the manufacture of batches for clinical trial from very small amount of bulk solution (e.g.: 100-200ml) assuring a minimum possible loss of bulk solution.