Therapeutical Protein Characterization

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