Biosimilars - BioRiver
Biosimilars - BioRiver
Biosimilars - BioRiver
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Protagen AG – Spectrum of Analytical Methods<br />
Analytical Method Description<br />
Mass Spectrometry<br />
Gel Electrophoresis<br />
Bioassay<br />
Amino Acid Analysis<br />
Spectroscopic assay<br />
Chromatography<br />
• Peptide Map to confirm identity of proteins<br />
• De novo sequencing mAB<br />
• N- and C-terminal sequencing of entire proteins<br />
• Site-specific PTM characterization<br />
• Structural analysis (Disulfide-Linkages, Glycosylation-sites, …)<br />
• Glycan analysis<br />
• Determination of total molecular weight<br />
• Quantitative analysis of complex protein mixtures<br />
• Sophisticated data quality control and evaluation<br />
• Continuous improvement of algorithms for data analysis<br />
• In-house software-development<br />
• High resolutions protein separation 1D up to 30cm, 2D up to 40x30 cm (16x12in)<br />
• Reducing / non reducing PAGE, IEF<br />
• Western blotting: antibody selection and validation via UNIchip ®<br />
• Cell-based bioassays<br />
• ELISA: antibody selection and validation via UNIchip ®<br />
• Standard and time resolved analysis<br />
• Modified amino acids (Hydroxyproline, Norleucine…)<br />
• Determination of extinction coefficient<br />
• Quantification<br />
• Fluorescence-scans<br />
• RP, IEX, SEC – HPLC/UPLC*<br />
• Glycan analysis: RP/NP HPLC with fluorescence labeling<br />
.HPAEC PAD detector label-free<br />
Protein characterization according to ICH Q6B and CHMP<br />
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