cGMP compliant analytical services from method development to technology transfer – or method qualification and validation to ICH guidelines – to aid the route for your assay to QC testing.
- HPLC (SEC, HIC, Reverse phase).
- icEF (capillary isoelectric focussing).
- Protein assays.
- Cell based assays.
In addition, we offer analytical testing for stability studies to support CMC submissions and manufacturing support through cleaning verification, environmental monitoring, microbiological testing and endotoxin testing.