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.

Source: Cambrex