Services
Comprehensive Characterization Services for Peptides and Peptide based Biopharmaceuticals
| pH | pH |
|---|---|
| Isotonicity | Osmolality |
| Identification of active ingredients | SDS-PAGE, Western Blot, CE, SDS-CE, HP-IEC, RP-HPLC, MALDI-TOF, LC-MS/CE-MS, Spectrophotometry, Peptide mapping, N-terminal sequencing, C-terminal sequencing, Ligand binding assays (SPR) |
| Purity | SDS-PAGE, CE, SDS-CE, HP-IEC, RP-HPLC, (LC MS) MALDI-TOF, spectrophotometry |
| Dissociation/ truncation/ deletion | SDS-PAGE, SDS-CE, cIEF, MALDI-TOF/MS, LC-MS, HP-SEC, Peptide mapping, N-terminal sequencing, C-terminal sequencing |
| Oxidation | RP-HPLC, peptide mapping, N-terminal sequencing, C-terminal sequencing |
| Association/ Aggregation | CE, LC-MS, HP-SEC, HP-SEC/MALLS |
| N-terminal blocking | N-terminal sequencing, Peptide mapping |
| Phosphorylation | Colorimetry, HP-IEC, peptide mapping |
| Molecular Weight | SDS-PAGE, SDS-CE, HP-SEC, LC-MS |
| Impurity profile | PAGE, SDS-PAGE, Western blot, CE, SDS-CE, HP-IEC, RP-HPLC, LC-MS, HP-SEC, HP-SEC, MALLS, spectrophotometry |
| Residual DNA | Spectrophotometry/ colorimetry, PCR |
| Residual host cell proteins | Western blot, ELISA |
| Residual solvent/ moisture | Karl-Fisher, GC-MS |
| Assay (mass) | PAGE, SDS-PAGE, CE, SDS-CE, HPLC (IEC, SEC, RP), Spectrophotometry/ colorimetry |
| Ligand Binding assay | Spectrophotometry/colorimetry, fluorescence, SPR, competitive inhibition, equilibrium dialysis, HP-SEC- column saturation technique |
| Secondary structure | CD, X-ray diffraction |
| Solution state structure conformation | CD, Fluorescence spectrophotometry, NMR (T1 or T2) |
Comprehensive Characterization Services for Non-glycosylated Proteins as Biopharmaceuticals
| pH | pH |
|---|---|
| Isotonicity | Osmolality |
| Identification of active ingredients | SDS-PAGE, Western Blot, CE, SDS-CE, HP-IEC, RP-HPLC, MALDI-TOF, LC-MS/CE-MS, Spectrophotometry, Peptide mapping, N-terminal sequencing, C-terminal sequencing, Ligand binding assays (SPR), Amino acid sequencing, CIEF, enzymatic activity |
| Purity | SDS-PAGE, CE, SDS-CE, HP-IEC, RP-HPLC, (LC MS) MALDI-TOF, spectrophotometry |
| Dissociation/ truncation/ deletion | SDS-PAGE, SDS-CE, cIEF, MALDI-TOF/MS, LC-MS, HP-SEC, Peptide mapping, N-terminal sequencing, C-terminal sequencing, HP-MALLS, analytical centrifugation |
| Oxidation | RP-HPLC, peptide mapping, N-terminal sequencing, C-terminal sequencing, LC-MS, CD |
| Association/ Aggregation | CE, LC-MS, HP-SEC, HP-SEC/MALLS, Analytical ultracentrifugation |
| N-terminal blocking | N-terminal sequencing, Peptide mapping |
| Phosphorylation | Colorimetry, HP-IEC, peptide mapping, cIEF |
| Post-translational modifications | IEF, cIEF, Peptide mapping, LC-MS |
| Molecular Weight | SDS-PAGE, SDS-CE, HP-SEC, LC-MS HPSEC MALLS, analytical ultracentrifugation |
| Impurity profile | PAGE, SDS-PAGE, Western blot, CE, SDS-CE, HP-IEC, RP-HPLC, LC-MS, HP-SEC, HP-SEC, MALLS, spectrophotometry |
| Residual DNA | Spectrophotometry/ colorimetry, PCR |
| Residual host cell proteins | Western blot, ELISA |
| Residual solvent/ moisture | Karl-Fisher, GC-MS |
| Assay (mass) | PAGE, SDS-PAGE, CE, SDS-CE, HPLC (IEC, SEC, RP), Spectrophotometry/ colorimetry |
| Assay (enzyme activity or inhibition) | Spectrophotometry/colorimetry, fluorescence, SPR, competitive inhibition, Non competitive inhibition, equilibrium dialysis |
| Ligand Binding assay | Spectrophotometry/colorimetry, fluorescence, SPR, competitive inhibition, equilibrium dialysis, HP-SEC- column saturation technique |
| Denaturation | CD, Fluorescence spectrophotometry |
| Secondary structure | CD, X-ray diffraction |
| Solution conformation | CD, Fluorescence spectrophotometry, NMR (T1 or T2) |
Comprehensive Characterization Services for Glycosylated Proteins as Biopharmaceuticals
| pH | pH |
|---|---|
| Isotonicity | Osmolality |
| Identification of active ingredients | SDS-PAGE, Western Blot, CE, SDS-CE, HP-IEC, RP-HPLC, MALDI-TOF, LC-MS/CE-MS, Spectrophotometry, Peptide mapping, N-terminal sequencing, C-terminal sequencing, Ligand binding assays (SPR), Amino acid sequencing, CIEF, enzymatic activity |
| Purity | SDS-PAGE, CE, SDS-CE, HP-IEC, RP-HPLC, (LC MS) MALDI-TOF, spectrophotometry |
| Dissociation/ truncation/ deletion | SDS-PAGE, SDS-CE, cIEF, MALDI-TOF/MS, LC-MS, HP-SEC, Peptide mapping, N-terminal sequencing, C-terminal sequencing, HP-MALLS, analytical centrifugation |
| Oxidation | RP-HPLC, peptide mapping, N-terminal sequencing, C-terminal sequencing, LC-MS, CD |
| Association/ Aggregation | CE, LC-MS, HP-SEC, HP-SEC/MALLS, Analytical ultracentrifugation |
| N-terminal blocking | N-terminal sequencing, Peptide mapping |
| Phosphorylation | Colorimetry, HP-IEC, peptide mapping, cIEF |
| Total Sugar | Colorimetry |
| Monosaccharide Composition analysis | HPAEC-PAD, RP-HPLC with fluorescent detection, CE, LC-MS, MALDI TOF |
| Oligosaccharide profile | HPASEC-PAD, RP-HPLC with fluorescence detection, CE, LC-MS, MALDI-TOF |
| Structure of oligosaccharides | HPASEC-PAD, RP-HPLC with fluorescence detection, CE, LC-MS, MALDI-TOF |
| Terminal galactose - exposed/ un exposed | Enzymatic digestion and colorimetry or HPAEC, Lectin binding assay/ Lectin affinity chromatography |
| Presence of Gal I 1, Gal | Lectin binding assay/ Lectin affinity chromatography, RP-HPLC with fluorescence detection, CE, LC-MS |
| Glycomapping | Peptide mapping (with/without glycosides digestion |
| Post-translational modifications | IEF, cIEF, Peptide mapping, LC-MS |
| Molecular Weight | SDS-PAGE, SDS-CE, HP-SEC, LC-MS, HPSEC MALLS + analytical ultracentrifugation |
| Impurity profile | PAGE, SDS-PAGE, Western blot, CE, SDS-CE, HP-IEC, RP-HPLC, LC-MS, HP-SEC, HP-SEC, MALLS, spectrophotometry |
| Residual DNA | Spectrophotometry/ colorimetry, PCR |
| Residual host cell proteins | Western blot, ELISA |
| Residual solvent/ moisture | Karl-Fisher, GC-MS |
| Assay (mass) | PAGE, SDS-PAGE, CE, SDS-CE, HPLC (IEC, SEC, RP), Spectrophotometry/ colorimetry |
| Assay (enzyme activity or inhibition) | Spectrophotometry/colorimetry, fluorescence, SPR, competitive inhibition, Non competitive inhibition, equilibrium dialysis |
| Ligand Binding assay | Spectrophotometry/colorimetry, fluorescence, SPR, competitive inhibition, equilibrium dialysis, HP-SEC- column saturation technique |
| Denaturation | CD, Fluorescence spectrophotometry |
| Secondary structure | CD, X-ray diffraction |
| Solution conformation | CD, Fluorescence spectrophotometry, NMR (T1 or T2) |
Comprehensive Characterization Services for Monoclonal Antibodies as Biopharmaceuticals
| pH | pH |
|---|---|
| Isotonicity | Osmolality |
| Identification of active ingredients | SDS-PAGE, Western Blot, CE, SDS-CE, HP-IEC, RP-HPLC, MALDI-TOF, LC-MS/CE-MS, Spectrophotometry, Peptide mapping, N-terminal sequencing, C-terminal sequencing, Ligand binding assays (SPR), Amino acid sequencing, CIEF, enzymatic activity |
| Purity | SDS-PAGE, CE, SDS-CE, HP-IEC, RP-HPLC, (LC MS) MALDI-TOF, spectrophotometry |
| Dissociation/ truncation/ deletion | SDS-PAGE, SDS-CE, cIEF, MALDI-TOF/MS, LC-MS, HP-SEC, Peptide mapping, N-terminal sequencing, C-terminal sequencing, HP-MALLS, analytical centrifugation |
| Oxidation | RP-HPLC, peptide mapping, N-terminal sequencing, C-terminal sequencing, LC-MS, CD |
| Association/ Aggregation | CE, LC-MS, HP-SEC, HP-SEC/MALLS, Analytical ultracentrifugation |
| N-terminal blocking | N-terminal sequencing, Peptide mapping |
| Phosphorylation | Colorimetry, HP-IEC, peptide mapping, cIEF |
| Total Sugar | Colorimetry |
| Monosaccharide Composition analysis | HPAEC-PAD, RP-HPLC with fluorescent detection, CE, LC-MS, MALDI TOF |
| Oligosaccharide profile | HPASEC-PAD, RP-HPLC with fluorescence detection, CE, LC-MS, MALDI-TOF |
| Structure of oligosaccharides | HPASEC-PAD, RP-HPLC with fluorescence detection, CE, LC-MS, MALDI-TOF |
| Terminal galactose - exposed/ un exposed | Enzymatic digestion and colorimetry or HPAEC, Lectin binding assay/ Lectin affinity chromatography |
| Presence of Gal I 1, Gal | Lectin binding assay/ Lectin affinity chromatography, RP-HPLC with fluorescence detection, CE, LC-MS |
| Glycomapping | Peptide mapping (with/without glycosides digestion |
| Post-translational modifications | IEF, cIEF, Peptide mapping, LC-MS |
| Molecular Weight | SDS-PAGE, SDS-CE, HP-SEC, LC-MS, HPSEC MALLS + analytical ultracentrifugation |
| Impurity profile | PAGE, SDS-PAGE, Western blot, CE, SDS-CE, HP-IEC, RP-HPLC, LC-MS, HP-SEC, HP-SEC, MALLS, spectrophotometry |
| Residual DNA | Spectrophotometry/ colorimetry, PCR |
| Residual host cell proteins | Western blot, ELISA |
| Residual solvent/ moisture | Karl-Fisher, GC-MS |
| Assay (mass) | PAGE, SDS-PAGE, CE, SDS-CE, HPLC (IEC, SEC, RP), Spectrophotometry/ colorimetry |
| Assay (enzyme activity or inhibition) | Spectrophotometry/colorimetry, fluorescence, SPR, competitive inhibition, Non competitive inhibition, equilibrium dialysis |
| Ligand Binding assay | Spectrophotometry/colorimetry, fluorescence, SPR, competitive inhibition, equilibrium dialysis, HP-SEC- column saturation technique |
| Denaturation | CD, Fluorescence spectrophotometry |
| Secondary structure | CD, X-ray diffraction |
| Solution conformation | CD, Fluorescence spectrophotometry, NMR (T1 or T2) |