PCI Synthesis, Inc. a 12-year-old custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products, announced the successful completion of a major expansion at its Devens, Mass. Research and Development facility.
The expansion, which includes several new research hoods, analytical instruments, additional support equipment, additional staff, and a major expansion to the site’s existing kilo lab capacity, was initiated to support PCI’s expanding activities in early- and late-stage clinical candidate programs. Since September 1st, the company has brought on board 20 new staff members in several functional areas to further support its growth in development of new compounds.
All together the additional staff and capacity enables PCI to offer its biotech and pharmaceutical customers a bridge from lab scale development to commercial manufacturing. This represents an important intermediate step as customers work on new compounds for new therapies, conduct clinical trials and seek to bring products to market. The 30-percent capacity increase positions PCI to handle increased customer demand.
Part of the expansion was driven by a new collaboration agreement with Biogen Idec to work closely with its process research group to augment its internal small-molecules capabilities and optimize a number of new compounds.
This expansion follows last month’s announcement of an eighth successful FDA inspection of PCI’s Newburyport facility and its sixth product pre-approval.
” PCI Synthesis’s ongoing investments in our people, our cGMP systems, and our analytical capabilities are paying off. Early stage development has played a significant role in achieving our mission to collaborate with our customers who rely on us to understand the complex dynamics of small-molecule development and manufacturing,”
said Edward S. Price, President of PCI Synthesis.
PCI Synthesis is a 12-year-old custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products. A contract manufacturing organization (CMO), PCI provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules and APIs used in generic pharmaceuticals. To learn more about PCI Synthesis, its proprietary NCE development activities and process R&D capabilities, please visit www.pcisynthesis.com.