Biologics Analytical Services
Biopharmaceutical analytical services covering the full characterization panel for antibodies, fusion proteins and conjugates. Identity, purity, charge and size heterogeneity, glycan profiling and potency — run to a defined specification and reported in a format your CMC team can file.
OVERVIEW
Everything a sponsor evaluating an outsourced biologics CMC partner needs to know — from capacity to compliance.
ChemPartner’s biologics analytical team offer full range of biologics analytical, biophysical capabilities supporting discovery and development of preclinical antibodies/therapeutic proteins.
| Parameter | Method | |
| Primary Sequence | Composition | Amino acid analysis (AAA) |
| Sequence confirmation | Peptide mapping, LC-MS/MS | |
| Glycosylation analysis | LC-MS/MS | |
| Disulfide bond shuffling | LC-MS/MS | |
| Charge analysis | cIEF, IEX | |
| Degradation | SEC, RPC, SDS-PAGE, cIEF, IEX, HIC | |
| Secondary Structure | CD | |
| Tertiary Structure | Intrinsic fluorescence | |
| 2nd derivative UV | ||
| Aggregation | Aggregates | SEC-MALLS, SDS-PAGE |
| Size | Dynamic Light Scattering (DLS) | |
| Thermal Stability | Capillary DSC | |
| High throughput DLS | ||
| Activity | Biacore, ELISA, Cell based assays | |
Our Services:
- Mass Spectrometry-based biologics characterization
- Integrated biologics developability assessment
- Biomolecular interaction analysis
