The BPDF offers a range of analytical testing services that support research, development, clinical and manufacturing activities. Testing services are performed using in-house standard operating procedures, or by current compendial testing requirements (USP/EP).
Assay | Test |
---|---|
Protein Content at A280 | Concentration |
BCA Protein Assay | Concentration |
Bioburden | Safety |
Cell Viability | Purity, Viability |
Color and Appearance | Safety, Identity |
Conductivity | Formulation |
Endotoxin | Safety, Purity |
Gram Stain | Identity, Purity |
Host Cell Protein | Purity, Process Residuals |
pH | Formulation |
Residual Antibiotics | Purity, Process Residuals |
Reverse Phase-HPLC/UPLC | Purity, Concentration |
Hydrophobic Interaction-HPLC/UPLC | Purity, Concentration |
Cation Exchange-HPLC/UPLC | Purity, Concentration |
SDS-Page | Identity, Purity |
Western Blot | Identity, Purity |
Size Exclusion-HPLC/UPLC | Purity, Aggregates |
Cell Assay | Test = Potency |
Total Organic Carbon | Safety, Water Purity |