Upperton offers a seamless transition from initial feasibility and development studies right through to GMP spray drying and production of the final dosage form for human clinical trials.
Our GMP capabilities include:
- Spray drying (aqueous and solvent)
- Scale up of production from grams to kilograms of formulated API
- Further processing through to final dosage form (e.g. capsule filling, tableting, device filling)
- Intermediate and finished product testing
- QA release (by in-house Qualified Person)
- Stability testing to ICH guidelines
The spray dried intermediate or final dosage form can be delivered to the designated clinical trials site.