Summary of Paul Erlich Institut Analysis of Antibody Regulatory Dossiers Where no Effective Reduction of Animal Parvoviruses Was Observed by Non-Binding Q-Sepharose Chromatography
| No. | mAb pI | pH | Conductivity or Load Buffer Composition | Column Load (g mAb/L resin) | Temp (°C) | Stepb | Parvovirus LRVf | Retrovirus LRVf |
|---|---|---|---|---|---|---|---|---|
| 1 | 8.6–9.0 | ?a | ?a | ?a | RTd | 3 | 3.5; 3.4 PPV | ≥6.7; ≥6.8 X-MuLV |
| 2 | 6.8–7.4 | 5.3 | 10.7 mS/cm | 45 | ?a | 3 | 2.0; 1.9 PPV | 6.39; 6.19 X-MuLV |
| 3 | 5.8–6.9 | 8.0 | 25 mM Tris.Cl 250 mM NaCl | 20 | RTd | 2 | 2.0 PPV | ≥ 4.39 E-MuLV |
| 4 | 4.5–6.4 | 7.0 | 180 mM NaCl 20 mM Na-phosphate | ?a | RTd | 1 | 1.4 MVM | n.d.g |
| 5 | 9.0 | 7.5 | 50 mM Tris 50 mM NaCl 100-225mM Na-acetate | 41 | 15-26 | 3 | 3.1; 4.3 MVM | ≥4.66 X-MuLV |
| 6 | 8.7–9.1 | 8.5 | Trish | 97 | RTd | 2 | 1.0; 0.9 PPV | ≥3.6; ≥3.9 X-MuLV |
| 7 | ?a | 7.5 | 5–7 mS/cm 20 mM Tris 17 mM acetic acid 62 mM NaCl | 50 | 16–25 | 2 | 0.9 MVM | 2.3 X-MuLV |
| 8 | 7.6 | 5.9–6.5 | ?a | 59.8 | ?a | 3 | 0.0; 0.2 MVM | 2.9; 4.0 X-MuLV |
| 9 | 9.5 | 8.0 | 140 mM Na-acetate 20 mM MESe | 40 | 17 ± 2.0 | 3 | ≤1.0; ≤1.0 | ≥4.8 X-MuLV |
| 10 | 7.4–8.3 | 6.5 | 15 mM Na-phosphate 140 mM NaCl | 5–20 | RTd | 3 | 1.9; 1.8 MVM | ≥4.9 ; >6.7 X-MuLV |
| 11 | 8.7–9.2 | 7.4 | PBSc | ?a | RTd | 2 | ≤1.0; ≤1.0 MVM | 2.6; 2.7 E-MuLV |
↵a Information was not provided in the investigational medicinal product dossier.
↵b Sequential number of chromatographic step at the purification process.
↵c PBS: polyphosphate buffered saline.
↵d RT: room temperature.
↵e MES: 2-(n-morpholino) ethanesulfonic acid.
↵f log10 reduction factors from single runs or double runs and model virus.
↵g n.d.: not determined.
↵h Elution intermediate from protein A chromatography was adjusted for pH with Tris base.