Patheon, a contract development and manufacturing organization of active pharmaceutical ingredients (APIs) and drug products, is investing approximately $45 million at various sites across its global network to expand its capabilities.

At its API development and manufacturing site in Florence, South Carolina, Patheon will be adding commercial spray-drying capabilities to complement the existing development capabilities at the company’s low-solubility center of excellence in Bend, Oregon. The 15,000-square-foot dedicated suite will contain two spray dryers for development- and commercial-scale spray-dried dispersion (SDD) services. The suite is expected to be on line in 2019. Patheon acquired the former Roche API manufacturing site in Florence in earlier this year. The site is Patheon’s flagship US API operation for commercial-scale and mid-scale API production.

At its Bend, Oregon site, the company plans to expand existing development SDD capabilities with a new cGMP analytical lab, manufacturing suite, and additional development-scale spray drying.

In addition, Patheon has invested in a new commercial sterile-product manufacturing facility at its site in Monza, Italy. The facility will house three, 40-square-meter lyophilizers with associated eight-headed integrated filling equipment for both lyo and liquid formulations for small and large molecules in a range of vial specifications. The equipment will have full cleaning-in-place/sterlization-in-place systems and auto loading for the lyophilizers contained in full restricted barrier access systems (RABS).

Patheon also plans to expand its sterile-product Pharmaceutical Development Services (PDS) at the Monza facility. The sterile suite will contain two 7-square-meter lyophilizers and an associated sterile vial-filling line and analytical laboratory. This new facility will provide development services for both small- and large-molecule injectable products (liquid and lyo formulations) and will be operational in mid-2019. All of Patheon’s PDS sterile suites are co-located within facilities with commercial-scale capabilities to ease the transition from clinical supply to commercialization.

Patheon will also expand its packaging and serialization capabilities at its site in Greenville, North Carolina. The company has built a new filling and packaging suite and upgraded another of its packaging lines with new technology to improve efficiency and reduce change-over time. The newly constructed 4,800-square-foot suite will come on line this fall and features a filling and packaging line equipped with an Optel serialization system. The system includes cameras, pharma proof stations, line master, and bottle and bundle tracker equipment.

These investments come as Patheon is being acquired by Thermo Fisher in a pending $7.2-billion deal. Thermo Fisher announced the acquisition in May 2017 with the deal expected to close by the end of 2017.

Source: Patheon