Full Cover Therapeutical Protein Characterization
Thanks to our wide equipment platform, GLP & GMP facilities, we offer a full cover of the protein characterization of great interest for therapeutical proteins.
We provide adapted solutions for quality control assays in accordance with current guidelines to guarantee the identity, the purity, titer, biological activity and the viral/prion safety of the final product.
To meet the ICH specifications, a pertinent protein characterization requires a large set of methodologies and usually needs to be designed case to case.
As a result, we have made accessible in our technical platform all state-of the art or pioneered methods as listed below:
| Parameters | Analytical Methods |
| Purity & ID (Titer) | Absorbance (UV-Vis), Biuret, BCA, Lowry, Bradford, Cell-based assays, Immuno-assays, HPLC-(SEC, RP, IEC, Affinity), Western Blot |
| Size | Reducing /non-reducing SDS-PAGE, Native PAGE, 2D-PAGE, HPLC-SEC, SEC-MALLS, DLS |
| Charge | CE, IEC, IEF |
| Primary structures | Amino acid composition analysis, PPM, MS-MS sequencing, RP-HPLC, MALDI-TOF |
| Secondary & tertiary structure | Far and near UV-CD spectroscopy, Microcalorimetry (DSC), NMR, intrinsic fluorescence spectrometry, FRET, limited proteolysis |
| Glycosilation sites, pattern/sequencing | Molecular mass : MALDI or ESI – Mass spectrometry Charge: e.g. glycan mapping with ion exchange chromatography and capillary electrophoresis/Glycan composition: ion exchange chromatography and mass spectrometry/Glycan sequence: enzymatic degradation and tandem mass spectrometry/Sialic acids : ion exchange chromatography |
| Aggregates, oligomer or non covalent complex | DLS, HPLC-SEC, Native PAGE, Cross Linking, SEC-MALLS |
| Process related Impurities (HCP / DNA threshold / IPTG / Bacterial endotoxin / kanamycin) | SDS-PAGE, 2D-PAGE, RP-HPLC, MALDI-TOF, ORBITRAP, Western Blot / ELISA (Residual Protein A), qPCR, Fluorescence detection, LAL test (bacterial endotoxin), RP-HPLC (IPTG & Kanamycin) |
| Potency | Cell-based assays, Enzyme-based assay, Immunological-based assay (SPR, ITC, absordance (UV-Vis), Fluorescence detection, FRET) |
| Viral & Prions Safety | See the dedicated page: Viral & Prion Safety |