Analytical Development
Customized analytical methods for each project
UGA Biopharma develops specific analytical procedures to ensure quality and safety in the manufacture of biosimilars and biologics. You benefit from a panel of analytical methods, compiled by our Analytical Development team to precisely meet your requirements. We guarantee monitoring of critical quality attributes (CQA) across all stages of cell line development as well as in upstream and downstream processing.
Our analytical development work serves to capture quantitative parameters, such as growth, titer and metabolic data from the bioprocess, and to qualitatively characterize biological products using, among others:
- Ion exchange chromatography (charge variant analyses)
- HILIC chromatography (N-glycosylation profile)
- Hydrophobic interaction chromatography (HIC)
- Size exclusion chromatography (SEC)
- Peptide mapping
- SDS-PAGE
- Western blotting
- ELISA
- In-vitro activity testing
- Liquid chromatography-mass spectrometry (LC-MS)
We also collaborate with highly skilled partners to implement complementary analytical methods, such as binding studies, and activity and potency assays.
Our Analytical Development team can answer any questions you may have!