Greenville, SC is experienced at process development and chemical production of intermediates and APIs for clinical and commercial supply under cGMP and ISO conditions. This 23 acre site was built in 1998, and is fully cGMP compliant.
- Production scales ranging from 2 kg to metric tons
- cGMP manufacturing of clinical and commercial materials
- Raw Material sourcing and specifications
- Process optimization; registration and validation campaigns
- Design of Experiment (DoE) and Quality by Design (QbD) studies
- Process safety studies
- Analytical method development and phase appropriate method validations
- Stability studies
- Regulatory submission assistance
Development & commercial scale capabilities include:
- Clinical Phase Small Molecule API (Phase I-III)
- Process & Analytical Development
- Clinical Batch API Manufacture
- Process Scale Up & Optimization
- Commercial API Manufacture
- High Potency (HPAPIs) and Cytotoxic Compounds
- Controlled Substances
- Stability Studies
Greenville, SC is routinely inspected by its clients and USA regulatory agencies, and has a history of strong regulatory inspection performance.
Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.