Enrico Zodio CEO Procos S.p.A.

In 2018, Procos SpA will launch its GMP manufacturing unit dedicated to high-potency active pharmaceutical ingredients (HPAPI) at its facility in Cameri, Italy, located near Milan. Enrico Zodio, CEO of Procos, detailed the investment at the DCAT Week ’18 Member Company Announcement Forum, which was held Monday, March 19, 2018 in New York.

The $21-million investment, which started in the first quarter of 2016, is now in the final stage of completion with process-validation activity scheduled for completion in the second quarter of 2018. The 1,200-square-meter HPAPI unit includes 500 square meters of production space, 500 square meters of laboratory space, and 200 square meters of warehouse/auxiliary space.

With the addition of the HPAPI unit, Zodio said Procos will widen its services in process and analytical development and GMP manufacturing as well as increase its flexibility to support global business partners and local centers of excellence focused on cancer research.

Zodio said Procos is planning to receive authorization from the Italian Ministry of Health (AIFA) for the B4 classification of drug products to allow manufacturing for the therapeutic category of oncology. The authorization from the AIFA is expected in the third quarter of 2018.

The HPAPI unit is the final phase of a larger investment and site-expansion project of $70 million that was initiated in 2014 and that was supported by Procos’ parent company, CBC Co. Ltd. Group, a privately held company based in Tokyo. The overall investment, inclusive of the new HPAPI unit, will increase Procos’ total capacity by 30% with an annual output of more than 300 metric tons of APIs and intermediates with a total reactor capacity of 450 cubic meters and a total area of 110,000 square meters. With the expansion, the company has grown to 360 employees. The expansion to the multipurpose facility enables Procos to offer product scales ranging from a few grams to multi metric tons to support the full lifecycle of products.