Pharma Services Fill, Finish & Drug Delivery CDMO

Sterile fill-finish operations and combination product support require a blend of precision, scalability, and regulatory alignment. Across three global facilities, specialized capabilities enable pharmaceutical teams to move from early-stage development to commercial readiness with confidence.

In Concord, North Carolina, automated and manual filling suites support GMP batches of up to 10,000 units, with nested syringe and vial formats, on-site microbiology, and bulk packaging. The Devens, Massachusetts site offers molding, assembly, and packaging for proprietary devices, with ISO 7 cleanroom operations and serialization capabilities. Meanwhile, the Cambridge, UK facility focuses on process development and analytical services, including container closure integrity testing (CCIT), mechanical device testing, and ICH stability studies. A dedicated pilot lab supports small-batch manual filling with flexible line configurations and integrated decontamination systems.

Each location is equipped to handle a range of container formats and fill volumes, from 0.5 mL to 100 mL, and adheres to ISO 13485 and FDA 21 CFR Part 4 standards. Whether supporting technical batches or scaling for commercial launch, these facilities provide the infrastructure and expertise needed to meet evolving market demands.