Pharmatek offers full development services for cytotoxic and high-potent compounds including:
- Analytical Method Development
- Preformulation Testing
- Formulation Development
- GMP Manufacturing of preclinical and Phase I/II clinical supplies
- Stability Storage and Testing Services
High-potent and cytotoxic development services are carried out in Pharmatek's dedicated high-potent/cytotoxic facility. The facility includes two validated class 100,000 high-containment suites designed with barrier technology for cGMP manufacturing of final form drug products. Design aspects include:
- Single pass HEPA filtered air
- Epoxy painted walls & welded sheet vinyl flooring
- Controlled access
- Personnel protected through strict gowning and control procedures
- Argon and Nitrogen gas capability for inert/dry environment control
- Clean dry air system for automated equipment
|