Recent weeks have seen two major Western contract development and manufacturing organizations (CDMOs) to the pharmaceutical and biotechnology industries continue their growth by adding entirely new sites. France’s PCAS has revealed plans to acquire an R&D center near Paris, which will become its global R&D platform, while Patheon has agreed to acquire an API facility in South Carolina. Both sites originally belonged to large pharma companies.
PCAS acquired its new site at Porcheville, 40 km (25 miles) from Paris and almost adjacent to another company site at Limay. The new location dates back to the 1970s and had been an R&D centre since 2004, passing most recently from Sanofi to the global CRO Covance in 2010. It was las inspected by the FDA in February 2015 and by the French equivalent, the ANSM, in March 2016.
According to CEO Vincent Touraille, Porcheville will become “the central platform for PCAS’ R&D projects” by the end of 2017. He added that pooling all of the teams there “will provide invaluable support to our innovation strategy, aimed at reducing development times and introducing powerful synergies.” Hitherto, PCAS’s R&D teams had been rather scattered across company sites, with pharma-related R&D at Limay, two other French sites at Longjumeau and Couterne and another at Turku in Finland.
The center will be responsible for innovation and both product and industrial process development, thus enabling PCAS to ramp up its R&D sub-contracting services. Covering a use area of more than 10,000 m2 (108,000 ft2), it features equipment for the development of complex molecules, plus seven kilo labs and 13 m3 of industrial pilot works over a works surface area of 1,000 m2: 4.2 m3 are described as ‘R&D pilot scale’, 8.8 m3 as industrial pilot capacity.
These labs will be used for testing new synthesis processes prior to routine manufacturing, something which is expected to be of specific interest to biotechs. The new site will also feature units specialized in crystallography and analytical method development. About 25 new employees have been taken on.
PCAS added that the equipment as a whole “will enable validation of products and industrial processes in accordance with the world’s most stringent standards,” is in line with GMP and complies with environmental standards. There will be a particular focus on the roll-out and operation of new technological supports and processes, which the company sees as critical “in view of the increasing complexity of the molecules developed by the pharmaceutical industry.” A dedicated generics team will also be created to help develop the catalog of proprietary products aimed at this market.
(PCAS is not the only French company in this field to acquire a nearby site of late, incidentally. In October, Axyntis acquired an API production unit from 3M next to its existing Orgapharm subsidiary’s site at Pithiviers in central France. This was also done with a view to strengthening Orgapharm’s resources at R&D and pilot level and the group’s ability to offer CDMO services).
By acquiring Roche’s 1,100 acre (445 hectare), 300,000 ft2 (28,000 m2) site at Florence, South Carolina, Patheon gains access to additional capacity for both development and manufacturing services for APIs. The facility brings with it extra capacity for highly potent compounds and capabilities to support solid state chemistry, micronization and — eventually, the company added - commercial spray drying.
Features include reactors of 50 to 11,000 liters, all fully compliant with cGMP, safety and environmental standards. About 200 employees will transfer in, adding to the existing corporate total of around 8,000.
Patheon, which calls itself “the only end-to-end provider of pharma development and manufacturing services,” acquired the site for “an immaterial sum, plus the cost of associated inventory and spare parts.” A multi-year supply agreement has been agreed with Roche, which should help Patheon to meet running costs while it seeks new clients. In the longer term, Florence is expected to have a similar financial profile to other drug substance sites in the Patheon network.