PCI Newburyport Facility
Corporate Headquarters, API Manufacturing, Quality, HES & Regulatory Affairs Groups
In 2005, PCI expanded its manufacturing facilities by acquiring its current site in Newburyport, Massachusetts. The facility had its most recent successful cGMP inspection by the FDA in April 2015.
- 65,000 sq. ft.
- Total capacity 20,000 gal
Manufacturing Capabilities
- Class 100,000 GMP kilo suites for Phase 1 and small scale cGMP manufacturing
- Pilot plant (50gal-200gal)
- Production plant (500-2000gal)
- Temperature capability of -50 to 225ºC
- Hastelloy, Glass, and Stainless vessels
Filtration/Drying
- Centrifuge
- Hastelloy and Glass Filter/Dryers
- Qualified USP Purified water system
PCI has the capabilities to support API manufacturing from pre-clinical development to commercial production all within one organization.
PCI Devens Facility
R&D and Chemical Synthesis Laboratories
In 2003, PCI Synthesis expanded its facilities by opening an API development facility in Devens, Massachusetts. This state-of-the-art facility houses our Research & Development and Chemical Synthesis Laboratories for small-scale development and production.
Facility Highlights:
- 10,000 sq. ft. facility with 6 laboratories that house 28 hoods.
- 30 person staff, ¾ PhD’s
- 5 kilo lab hoods
Equipment:
- Glassware from ml to 100 liter jacketed glass vessels
- 20 and 50 liter rotovaps
- Various filtration equipment
- Temperature ranges -78 – 240°C
- Thin film evaporation
- Flash chromatography
- Prep chromatography
- Micronization
- High pressure par reactors
