Table IV.
Typical Use of Techniques in Industry with Respect to Aggregate Analysis
| Method | Validation | Quantification | Robustnessa | Sensitivitya | Sample throughputa,b | QC methodc |
|---|---|---|---|---|---|---|
| Visual inspection | Yes | No | Medium | Medium | High | Yes |
| Optical microscopy | No | Possible | Medium | N/A | Low | No |
| Fluorescence microscopy | No | No | Low | High | Low | No |
| Electron microscopy | No | No | Low | N/A | Low | No |
| Flow imaging | No | Yes | Low | N/A | Medium | No |
| Atomic force microscopy | No | No | Medium | N/A | Low | No |
| Turbidity | Yes | No | High | Medium | Medium | Yes |
| DLS | No | No | Medium | High | High | No |
| SEC-MALLS | No | No (MALLS part) | Medium | High | High | No |
| Light obscuration | Yes | Yes | Medium | Medium | Medium | Yes |
| “Native” mass spectrometry | No | No | Low | Medium | Low | No |
| Macro-IMS | No | No | Low | N/A | Medium | No |
| AUC | No | Yes | Low | Medium | Low | No |
| SEC | Yes | Yes | High | Medium | High | Yes |
| AF4 | Yes | Yes | Medium | Medium | High | No |
| SDS-PAGE | Yes | Possible | Medium | Medium | High | Yes |
| Native PAGE | Yes | Possible | Medium | Low | Medium | No |
| CE-SDS | Yes | Yes | Medium | Medium | High | Yes |
| UV-VIS spectroscopy | No | No | Medium | Medium | High | No |
| Infrared spectroscopy | No | No | Medium | N/A | Low | No |
| Raman spectroscopy | No | No | Medium | N/A | Low | No |
| Fluorescence spectroscopy | No | No | Medium | N/A | High | No |
| Circular dichroism spectroscopy | No | No | Medium | N/A | Medium | No |
| NMR spectroscopy | No | No | Medium | Medium | Medium | No |
aScoring (low, medium, or high) was based on consensus of opinion of the authors; N/A = not available; bLow: <10; medium; 10–25; high >25 per day and per operator; cQC = quality control; all listed methods can be used for extended characterization; see Table I for definitions