Characterization Services
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Mycenax’s product characterization services provide clients with comprehensive insights into a drug’s physicochemical properties and biological activities. The service covers primary structure, higher-order structure, glycan profiling, binding affinity, as well as immunological and functional properties. These insights are crucial throughout R&D and later development stages. Particularly in biosimilar development, similarity assessments based on these analyses can significantly accelerate the time to market. |
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| “Trusted Results from Mycenax’s Experts and Advanced Facilities.” | |||||||
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Our Product Characterization Services
◆ Physiochemical information
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Items |
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Methods |
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Molecular weight (Intact) | LC-MS | ||
| Molecular weight (Reduced) | LC-MS | |||
| Molecular weight (De-N-glycosylated and reduced) | LC-MS | |||
| Intact molecular weight | SEC-MALS | |||
| Sedimentation coefficient value | SV-AUC | |||
| Melting temperature (Tm) | Differential scanning calorimetry (DSC) | |||
| Particle size | Dynamic light scattering | |||
| UV/Vis spectroscopy | Spectrophotometer | |||
◆ Primary structure
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Items |
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Methods |
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| Full amino acid sequencing | LC-MS/MS | |||
| N-terminal amino acids | Edman degradation | |||
| Peptide mapping | LC-MS/MS | |||
| Extinction coefficient | RP-HPLC | |||
| Amino acid composition | RP-HPLC | |||
◆ Higher order structure
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Items |
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Methods |
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| Disulfide bond position | LC-MS/MS | |||
| Free thiol | Ellman reagent | |||
| Tertiary structure | Circular dichroism (CD; near-UV) | |||
| Secondary structure | Circular dichroism (CD; far-UV) | |||
| Secondary structure | FT-IR spectroscopy | |||
◆ Glycan structure
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Items |
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Methods |
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| Sites and occupancy of N-linked glycan | LC-MS/MS | |||
| N-linked oligosaccharide | HILIC-UPLC | |||
| O-linked oligosaccharide | LC-MS | |||
| Monosaccharide composition | RP-HPLC | |||
| Sialic acid content | RP-HPLC | |||
◆ Post-Translational Modification (PTM)
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Items |
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Methods |
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| Glycation | LC-MS/MS | |||
| Oxidation | LC-MS/MS | |||
| Deamidation | LC-MS/MS | |||
| Carbamylation | LC-MS/MS | |||
| Pyroglutamate (pyro-E) | LC-MS/MS | |||
| C-terminal lysine heterogeneity (K-clipping) | LC-MS/MS | |||
◆ Biological Activity
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Items |
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Methods |
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| Binding affinity to antigen family | SPR | |||
| Binding affinity to growth factors | SPR | |||
| Binding affinity to related proteins | SPR | |||
| Binding affinity to Fcγ receptors (FcγRI, FcγRIIa, FcγRIIIa, etc.) | SPR | |||
| Binding affinity to FcRn | SPR | |||
| Binding affinity to C1q | SPR | |||
| Inhibition of cell proliferation | Cell-based assay | |||
| Inhibition of cell migration | Cell-based assay | |||
| Inhibition of phosphorelation | Cell-based assay | |||
| ADCC | Cell-based assay | |||
| CDC | Cell-based assay | |||
| Binding affinity to antigen family | ELISA | |||
|
Mycenax’s product characterization services provide clients with comprehensive insights into a drug’s physicochemical properties and biological activities. The service covers primary structure, higher-order structure, glycan profiling, binding affinity, as well as immunological and functional properties. These insights are crucial throughout R&D and later development stages. Particularly in biosimilar development, similarity assessments based on these analyses can significantly accelerate the time to market. |
||||||||
|
|
||||||||
| “Trusted Results from Mycenax’s Experts and Advanced Facilities.” | ||||||||
|
|
Our Product Characterization Services
◆ Physiochemical information
|
Items |
|
Methods |
||
| Molecular weight (Intact) | LC-MS | |||
| Molecular weight (Reduced) | LC-MS | |||
| Molecular weight (De-N-glycosylated and reduced) | LC-MS | |||
| Intact molecular weight | SEC-MALS | |||
| Sedimentation coefficient value | SV-AUC | |||
| Melting temperature (Tm) | Differential scanning calorimetry (DSC) | |||
| Particle size | Dynamic light scattering | |||
| UV/Vis spectroscopy | Spectrophotometer | |||
◆ Primary structure
|
Items |
|
Methods |
||
| Full amino acid sequencing | LC-MS/MS | |||
| N-terminal amino acids | Edman degradation | |||
| Peptide mapping | LC-MS/MS | |||
| Extinction coefficient | RP-HPLC | |||
| Amino acid composition | RP-HPLC | |||
◆ Higher order structure
|
Items |
|
Methods |
||
| Disulfide bond position | LC-MS/MS | |||
| Free thiol | Ellman reagent | |||
| Tertiary structure | Circular dichroism (CD; near-UV) | |||
| Secondary structure | Circular dichroism (CD; far-UV) | |||
| Secondary structure | FT-IR spectroscopy | |||
◆ Glycan structure
|
Items |
|
Methods |
||
| Sites and occupancy of N-linked glycan | LC-MS/MS | |||
| N-linked oligosaccharide | HILIC-UPLC | |||
| O-linked oligosaccharide | LC-MS | |||
| Monosaccharide composition | RP-HPLC | |||
| Sialic acid content | RP-HPLC | |||
◆ Post-Translational Modification (PTM)
|
Items |
|
Methods |
||
| Glycation | LC-MS/MS | |||
| Oxidation | LC-MS/MS | |||
| Deamidation | LC-MS/MS | |||
| Carbamylation | LC-MS/MS | |||
| Pyroglutamate (pyro-E) | LC-MS/MS | |||
| C-terminal lysine heterogeneity (K-clipping) | LC-MS/MS | |||
◆ Biological Activity
|
Items |
|
Methods |
||
| Binding affinity to antigen family | SPR | |||
| Binding affinity to growth factors | SPR | |||
| Binding affinity to related proteins | SPR | |||
| Binding affinity to Fcγ receptors (FcγRI, FcγRIIa, FcγRIIIa, etc.) | SPR | |||
| Binding affinity to FcRn | SPR | |||
| Binding affinity to C1q | SPR | |||
| Inhibition of cell proliferation | Cell-based assay | |||
| Inhibition of cell migration | Cell-based assay | |||
| Inhibition of phosphorelation | Cell-based assay | |||
| ADCC | Cell-based assay | |||
| CDC | Cell-based assay | |||
| Binding affinity to antigen family | ELISA | |||