Cambrex Opens New API Pilot Plant
Cambrex has opened its new active pharmaceutical ingredient (API) pilot plant in Milan, Italy, following validation and ISO certification. The cGMP plant, which can produce batch sizes from 1 kilogram to 15 kilograms, was constructed to meet demand for small-scale API volumes and for API supply to niche markets.The new facility will also provide custom manufacturing of new chemical entities and intermediates for early-stage drug development and clinical trials.
The new facility is equipped with a hydrogenator that can operate at 30 bar and two separate lines of 150-liter glass-lined and stainless steel reactors. ISO 8 classified, the plant is also equipped with a static dryer, milling, and micronization capabilities.
Cambrex plans a further upgrade of the pilot plant in 2017 to support production of Class 3/4 high-potency products.