Cambrex Validates Milan API Pilot Plant
US life sciences company Cambrex has completed and validated a new pilot plant at its manufacturing and R&D site in Paullo, Milan, Italy. Built to meet customer demand for small-scale API volumes, the ISO 8-certified cGMP plant produces batch sizes from 1kg to 15kg, both for validation to support a Drug Master File (DMF) for Abbreviated New Drug Applications (ANDA) or generic registrations and for supplying APIs to niche markets, including ophthalmic drugs.
The new facility will also custom manufacture New Chemical Entities (NCEs) and intermediates for early stage drug development and clinical trials. Managing director of Cambrex Milan, Aldo Magnini, said the expansion of its small-scale production provides greater speed, flexibility and capacity for its global customers, adding that the company’s current portfolio comprises more than 70 generic APIs.
Equipment at the plant includes a hydrogenator, two separate lines of 150 liter glass-lined and stainless steel reactors, a static dryer, milling and micronization capabilities. Cambrex is planning a further upgrade of the pilot plant in 2017 to support production of Class 3/4 high potency products.
The company has been boosting its API services this year. In July, it announced the validation of a $50 million expansion at its cGMP site in Charles City, Iowa, USA. Last month, Cambrex spent $25 million on buying PharmaCore, a North Carolina-based company specializing in the commercial development of small molecule drugs.
