Table 4.
Suggested entries in a supplemental antibody information sheet
| Suggested entries | Available tools |
|---|---|
| 1. Naming system | |
| INN name and date | MedNet-INN |
| Trade name | |
| National nomenclature (e.g. USAN) | |
| 2. Biological function | |
| 3. Development | |
| Company | |
| Source | |
| Patent information | Espacenet patent search |
| 4. Sequence information | |
| Isotype/subtype | |
| Germline alignment | IMGT/DomainGapAlign |
| Canonical structure class | Abysis |
| FR/CDR definition and lengths | Abysis |
| – Kabat | |
| – Chothia | |
| – IMGT | IMGT/DomainGapAlign |
| 5. Protein/formulation properties | |
| Binding properties | |
| – Antigen specificity | |
| – Affinity (KD) | |
| – Binding rates , | |
| Biophysical properties | |
| – Thermal/chem. stability | |
| – pI | Expasy/ProtParam |
| – Aggregation propensity (hydrophobic patches) | |
| PTMs | |
| – Glycosylation sites | NetNGlyc |
| – Terminal lysine modifications | |
| Crystal structure | |
| Expression system | |
| 6. Immunogenic risk assessment | |
| In-silico analysis | |
| – T cell epitopes | IEDB |
| – Humanness | Abysis |
| – Human string content (HSC) | |
| in-vitro tests | |
| – T-cell activation assays | |
| Clinical | |
| – Anti-drug antibody (ADA) titer | |
| 7. Other clinical data | |
| Therapeutic area/ indication | IMGT/mAb-DB |
| EMA/FDA approval year | |
| Prescription information | FDA drug database (drugs@FDA) |
| Biological half-life |