Process Validation and Tech Transfer Services
From Drug Substance
In late clinical phases, and as part of the establishment of your commercial supply, Patheon provides a complete validation package according to regulatory and cGMP guidelines.
- Process validation with critical parameters
- Validation of analytical assays
- Virus validation of the downstream process
- Resin re-use and hold time studies
- Stability studies for various ICH climatic zones
- Container shipment studies
- Release testing
- CMC documentation in CTD format
You’ll have access to everything you need to ensure the reliability of your supply and consistent high quality.
At Patheon we see tech transfers as an opportunity to use our integration and efficiency to give our clients a strategic and financial advantage. Technology transfers, for scale-up or to move a project between facilities, are part of the normal course of business. But even when the transfer is urgent, Patheon can execute it quickly and effectively to get your project back on track and preserve the supply of product. In all cases, we are driven by your deadlines, flexible in our approach and determined to get it right the first time, every time.