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Protein & Host Cell Protein (HCP) characterization

Bertin Pharma, together with the French Atomic Energy Commission (CEA), offers a wide range of analytical methods to assess appropriate specifications of therapeutic proteins from active ingredient to finished product.

 

Thanks to our wide equipment platform, GLP & GMP facilities, we can offer you a full cover of the protein characterization. We provide adapted solutions for quality control assays in accordance with current guidelines to guarantee the identity , the purity and titer 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:


 ParametersAnalytical 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
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), Fluorescence detection, LAL test (bacterial endotoxin), RP-HPLC (IPTG & Kanamycin)
 PotencyCell based assays, Enzyme based assay, Immunological based assay (SPR, ITC, absordance (UV-Vis), Fluorescence detection, FRET)
BCA: BiCinchoninic Acid; CD: Circular Dichroïsm; DCS:    Differential Scanning calorimetry; DLS: Dynamic Light Scattering; FRET: Fluorescence Resonance Energy Transfer; IEC: Ion-exchange chromatography; IEF: IsoElectric Focusing gel electrophoresis; ITC: Isothermal Titration Calorimetry; HP-SEC: High Performance Size Exclusion chromatography; MALDI-TOF: Matrix-Assisted Laser-Desorption Ionization–Time of Flight; MS: Mass Spectrometry; NMR: Nuclear Magnetic Resonance: RP-HPLC: Reverse Phase High-Performance Liquid Chromatography; SDS-PAGE: Sodium Dodecyl Sulfate PolyAcrylamide Gel Electrophoresis; SEC-MALLS: Size Exclusion Chromatography Multi-Angle Laser Light Scattering; SPR: Surface Plasmon Resonance; UV: Ultra Violet

Our strength is to offer both a fully integrated package and customized solutions thanks to:

  • A large analytical and formulation platforms
  • Our single project manager as your dedicated contact
  • A board of experts covering all specialties from recombinant protein production, physico-chemistry analysis, formulation, bioamalysis and regulatory affairs
  • Adapted solutions for QCs in accordance with ICH quality guidelines Q6B & Q2


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Services > Services > Biologics > Protein & HCP analysis