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Full Cover Therapeutical Protein Characterization

Therapeutical Protein Characterization Bertin Pharma

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

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78180 Montigny le Bretonneux - France
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