Olon to open US HPAPI suite

Italian CDMO Olon Group has announces the ongoing construction of a high potency API (HPAPI) suite at the site in Concord, Ohio, which hosts its centre of excellence for early development of APIs. This adds to the commercial-scale capabilities of sites at Segrate and Rodano, near Milan, Italy, where Olon has invested about €40 million in the last few years.

The facility will have an OEL of <1 µg/m³ (OEB 5). This makes it highly integrated with the Italian sites that can produce HPAPIs in batches ranging of 30-150 kg. As additional safety data becomes available, the site can adapt protocols, accordingly, allowing scale-up for 1-10 µg/m³ OEL (OEB 4) or lower bands into the pilot plant using continuous liner and the portable filter dryer, which is rated to OEB5.

“The suite will significantly expand our capabilities to serve clients developing innovative therapies for cancer, rare diseases, and other challenging therapeutic areas” said Giorgio Bertolini, senior VP of R&D.

“Today we are one of the few API suppliers to offer the range of specific integrated capabilities necessary to support the customer from the first clinical phase up to industrialisation, regardless of the quantity of product needed and batch size required and regardless of the ongoing molecule development phase.”