Upperton offers a seamless transition from initial feasibility and development studies right through to cGMP spray drying and production of the final dosage form for human clinical trials.
Our cGMP spray drying is undertaken at the Quotient Sciences MHRA-approved facility in Nottingham.
Our cGMP 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 or alternatively the trial formulation can be administered to volunteers in the Quotient clinical trials facility.