BioPharmaSpec provides a comprehensive range of protein characterization services to meet global regulatory requirements for characterization of your biopharmaceutical.
Whether you are developing a biosimilar, a novel molecule, a peptide, an antibody, a bi/multi-specific, a drug-conjugate or any other molecule, our scientists are skilled in the analytical methods required for efficient structural, physicochemical and biophysical characterization of your product!
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Protein Characterization Methods
| Amino Acid Analysis | Triplicate hydrolysis, duplicate injection |
| N-terminal Sequencing | 15 cycles (of light and heavy chains) |
| C-terminal sequencing | Determined through molecular weight and peptide mapping |
| Peptide Mapping | At least three digestion strategies LC/ES-MS, Q-TOF |
| Glycosylation site occupancy | Assessment of the degree of glycosylation site occupancy |
| Primary sequence confirmation | MS based sequencing and Ile/Leu differentiation using Edman for the full sequence |
| Disulfide Bridge Assessment | Determined through peptide mapping |
| Monosaccharide Composition Analysis | Neutral and amino sugars Sialic acids |
| Oligosaccharide profiling | HILIC analysis of 2-AB labelled oligosaccharides covering the analysis of total N-glycans Linkage (methylation) analysis |
| Intact molecular weight analysis | As received, following reduction, following de-N-glycosylation, following reduction and de-N-glycosylation. On line RP-HPLC-MS |
| icIEF | With and without Carboxypeptidase B treatment |
| CE-SDS | Non reducing and reducing |
| RP-HPLC with UV detection | Performed on the sample as received |
| Ion Exchange Chromatography | Isoforms can be collected and characterized |
| DSC | To assess melting temperature |
| CD | For far-UV (for secondary structure) and near UV (for tertiary structure) |
| FT-IR | Secondary structure |
| IF | Secondary and tertiary structure |
| 1D and 2D NMR | Secondary and tertiary structure |
| SEC-MALS | Aggregation assessment |
| SV-AUC | Orthogonal aggregation assessment |
| Cell based assay(s) | Functional assessment |
| Binding assay(s) | Assessment of binding affinity to receptors, ligands etc |
Need protein structure characterization services?
Work with our scientists to obtain quality analytical data, allowing you to make solid development decisions.