High Point, NC, USA

Overview

Our team in High Point focuses on the development and manufacture of active pharmaceutical ingredients (APIs) to support clinical trials from Phase I to Phase III, as well as small-scale commercial manufacturing starting in late 2023. Our integrated team of experienced process chemists, process engineers, and analytical chemists offer state of the art chemistry and manufacturing support and expertise.Our team of PhD-level process and analytical chemists and research engineers offer GMP API development services.

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

Facility Details

• Technical project management- core strength with Ph.D. PMs averaging 15 years’ experience.
• Chemistry laboratory (custom synthesis, discovery research, and process development)
• Process engineering laboratory (continuous flow process and separations process development)
• 8 kilo-scale reactors (20 L, 30 L and 100 L) for GMP synthesis
• Pilot-scale reactors (200 L, 800 L, 1,200 L and 2,000 L reactors) for GMP synthesis
• Temperature range from -70°C to +160°C (GMP pilot plant capability)
• 78 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