Drug Product Manufacturing

This drug product manufacturing offering provides fully integrated GMP support across solid oral dose, sterile parenteral, and complex formulation needs. Capabilities span small and large molecule development, lyophilized products, high‑potency compounds, and DEA‑scheduled materials. Facilities in Charleston and RTP deliver robust aseptic manufacturing with isolator‑based filling for liquid and lyophilized vials, pre‑filled syringes, terminal sterilization, and extensive laboratory testing for both biologics and small molecules. Storage options include –80°C, –20°C, 5°C, and controlled room temperature, enabling seamless handling across the full development lifecycle.

Oral solid dose manufacturing is supported through flexible suites offering wet granulation, roller compaction, film coating, mini‑tablets, encapsulation, and high‑volume blending. Packaging and labeling services include bottles, blisters, vials, pre‑filled syringes, clinical labeling, serialization, aggregation, trial‑kit assembly, and cold‑chain logistics. These integrated services streamline development from first‑in‑human through commercial supply, reducing operational complexity and strengthening supply‑chain continuity.