Overview

Focus and specialize in early phase clinical supply and process development.

From our site in High Point, North Carolina, USA, we develop, manufacture and scale-up small molecule APIs and intermediates to support clinical trials from Phase I to Phase III.

Home to a team of more than 60 employees, the site has a 15,000 sq. ft. chemistry laboratory and a 13,000 sq. ft. pilot plant, with reactor capacity ranging from 20L to 2000L.

Our team of PhD level Process and Analytical Chemists offer GMP analytical services.

Our site is licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances.

Facility details

  • Chemistry laboratory (custom synthesis, discovery research and process development)
  • 8 kilo scale reactors (20L, 30L and 100L) for GMP synthesis
  • Pilot scale reactors (200L, 800L, 1,200L and 2,000L reactors) for GMP synthesis
  • Temperature range from -70 ̊C to +160 ̊C (GMP capability)
  • 43 bench-top hoods and 18 walk-in hoods for chemistry projects
  • Controlled substance R&D and manufacturing capability Schedule II to Schedule V
  • GMP compliant chemical storage with quarantine for raw materials, intermediates and finished products
  • Process safety testing
  • Analytical services
  • Project management
  • Strong regulatory history