Current MAb Platform versus Historic Data Set
| Step | Stringent MAb Platform | Historic Data Set (includes MAbs, FAbs, nanobodies) | Viruses Tested |
|---|---|---|---|
| Affinity chromatography (ALC) | 1 resin Identical wash buffer | 2 resins Different wash buffers | MuLV |
| Cation exchange chromatography–bind elute (CEC) | 1 resin Salt gradient only Eluate pH 5.5–6.0 Conductivity ≤14 mS/cm | 3 resins pH and salt gradients Eluate pH 5.5–7.0 Conductivity ≤14 mS/cm | MuLV |
| Multimodal anion exchange chromatography–flowthrough (MAC) | 1 resin pH 6.0 Conductivity ≤14.0 mS/cm | 1 resin pH 6.0–7.8 Conductivity ≤14.0 mS/cm | MuLV, MVM |
| Low-pH inactivation (VIN) | pH 3.6–3.7 Temperature: 16–18°C Minimum inactivation time: 60 min | pH 3.6–3.8 Temperature: 16–23.5°C Minimum inactivation time: 60 min | MuLV |
| Virus removal filtration (VRF) | 2 filters (20 nm) Highly similar conditions | 2 filters (20 nm) Higher variability | MuLV, MVM |