Table 1.
Test methods used for physicochemical and biological similarity assessment between CT-P10, EU-rituximab and US-rituximab.
| Attribute | Clinical Relevance | Test Method |
|---|---|---|
| Primary Structure | Efficacy, Safety, Immunogenicity | Peptide Mapping (HPLC) |
| Peptide Mapping (LC-MS) | ||
| Intact Mass (LC-MS) | ||
| Amino Acid Analysis | ||
| Extinction Coefficient | ||
| N-terminal Sequencing | ||
| C-terminal Sequencing | ||
| Higher Order Structure | Efficacy & Immunogenicity | Fourier Transform Infrared Spectroscopy (FTIR) |
| Differential Scanning Calorimetry (DSC) | ||
| Circular Dichroism (CD) | ||
| Free Thiol Analysis | ||
| Disulfide Bond | ||
| Content | Efficacy (PK) | Protein Concentration (UV280) |
| Purity | ||
| /Impurity | Efficacy & Immunogenicity | Size-exclusion Chromatography (SEC)-HPLC |
| Size-exclusion Chromatography (SEC)-MALS | ||
| Analytical Ultracentrifugation (AUC) | ||
| Residual Host Cell Protein | ||
| Residual Host Cell DNA | ||
| Residual rProtein A | ||
| Efficacy | Non-reduced Capillary Electrophoresis (CE)-SDS | |
| Reduced Capillary Electrophoresis (CE)-SDS | ||
| Charge Variants | Efficacy | Isoelectric Focusing (IEF) |
| Ion Exchange Chromatography (IEC)-HPLC | ||
| Glycosylation | Efficacy & Immunogenicity | Oligoprofiling by HILIC-UPLC |
| N-linked Glycan Analysis | ||
| Sialic Acid Analysis | ||
| Monosaccharide Analysis | ||
| Glycation | ||
| F(ab')2-related | Efficacy | Cell-based CD20 Binding Affinity |
| Apoptosis | ||
| Fc-F(ab')2-related | Efficacy | CDC |
| ADCC using PBMC | ||
| ADCC reporter assay | ||
| ADCP | ||
| Fc-related | Efficacy | C1q Binding Affinity |
| FcγRIIIa-V Binding Affinity | ||
| FcγRIIIa-F Binding Affinity | ||
| FcγRIIIb Binding Affinity | ||
| FcγRIIa Binding Affinity | ||
| FcγRIIb Binding Affinity | ||
| FcγRI Binding Affinity | ||
| FcRn Binding Affinity |