Analytical Development and Testing
- Development, Qualification and Validation
- Non-GMP Stability Studies
- GMP Testing and Stability Studies
Drug Product Development
- Injectable formulations-liquid and lyophilized dosage formulation
- Pre-Formulation and Formulation Development, Lyophilization Cycle Development
- Parenterals (IM, IV, SC, IT), Ocular, Topicals, Orals
- Nanotechnology
- Small-scale Filling (up to 1,000 vials/PFS/day for tox/demo batches)
- Syringeability/Injectability and Bedside Stability Studies
Bulk Drug Substance Development
- Cell Line and Clone development
- Transient transfection, creating stable pools.
- Cell Culture up to 50 L bioreactors & Purification
- Process characterization