cGMP Biopharmaceutical Services
Understanding biopharmaceutical stability is one of the most critical and challenging aspects of biopharmaceutical development.
The complexity of these molecules provides literally thousands of possible sites for degradation including deamidation, truncation, oxidation, reduction and aggregation.
EAG can develop, validate and implement a wide variety of assays in support of your cGMP release testing and stability studies including:
- Cell Bioassay
- Excipients (surfactants, sugars)
- Host Cell Protein and DNA
- Sterility and Endotoxin
- Residual solvents
- Residual heavy metals
These days, thorough characterization of degradants is not just important to decision-making, it is a regulatory mandate.