Filter Model virus3 Load virus Titer/spike conc. TMP (psi) Volumetric throughput (L/m2) Feedstream protein type Feedstream protein conc. (g/L) Feedstream pH / conductivity Flow pause (min) LRV1,2 Ref.
Planova 20N PPV 6.0-6.5 log10TCID50 /mL (0.5% spike) 11.4 NA Polyclonal antibody, pI 6.8 - 10 1 - 50 pH 5, 100 mM NaCl NA ≥ 5.42 (Hongo-Hirasaki, Komuro et al. 2010)
PPV
0.1 % single spike
14 ±2
100-200
mAbs, therapeutic proteins, and bi-specific antibodies (9 molecules)
3.1 - 13.0
pH 4.9 - 8.3, various buffers with 50-300 mM NaCl
Yes
2.86 – 7.15
(Stuckey, Strauss et al. 2014)
0.1% mixed spike with 2.5% MMV
110-190
mAbs (6 molecules)
4.2 – 13.0
pH 4.9 - 8.3, various buffers with 50-200 mM NaCl
3.59 – 5.19
PPV 1:50 single spike manufacturer recommendation ~13 50 Prothrombin complex concentrate solution 2.6 pH 6.5 sodium citrate buffer and 15 mM NaCl 2 ≥6.0 (Nowak, Popp et al. 2019)
Mixed spike with CPV and MMV ≥5.8
MMV NA NA 200-400 23 mAbs (IgG1 and IgG2) NA pH 5.0 – 7.5 NA Approx. ≥3.9 – ≥6.9 (Gefroh, Dehghani et al. 2014)
MMV Approx. 6.0 Log10TCID50 /mL, 1% (v/v) spike 7.3 – 16.0 50 3 mAb molecules (IgG1), pI 7.2-9.0 5.0 pH 4.0 – 8.0, conductivity3.0-20.0 mS/cm 15 4.0 - ≥5.5 (Strauss, Goldstein et al. 2017)
2.8 NA 2.9 - ≥5.0
MMV 1:50 single spike manufacturer recommendation ~13 50 Prothrombin complex concentrate solution 2.6 pH 6.5 sodium citrate buffer and 15 mM NaCl 2 ≥7.3 (Nowak, Popp et al. 2019)
1:50 mixed spike with CPV and B19V 2.9 1.7 ≥5.7
CPV 5.5 – 8.5 log10 CCID50/ 0.001m2, 1:50 single spike manufacturer recommendation ~13 50 Prothrombin complex concentrate solution 2.6 pH 6.5 sodium citrate buffer and 15 mM NaCl 2 3.8 ± 0.7 (Nowak, Popp et al. 2019)
1:50 mixed spike with MMV and B19V 2.9 1.7 2.9
B19V
1:50 single spike
13
50
Prothrombin complex concentrate solution
1.7
pH 6.5 sodium citrate buffer and 15 mM NaCl
2
≥4.4
(Nowak, Popp et al. 2019) (Nowak, Popp et al. 2019)
1:50 mixed spike with CPV and MMV 13 ≥4.3
1:50 mixed spike with CPV and MMV 2.9 ≥6.8
Viresolve Pro MMV 0.1% spike NA 904-1042 mAb NA pH 5.0, 50 mM acetate NA ≥4.68 (Gefroh, Dehghani et al. 2014)
NA
10 - 50
125 - 500
mAb
5-40
pH 4.5, or pH 7.5, with 0-500 mM NaCl
NA
5.20 - ≥ 6.10
(Chen 2014)
6.47-8.22 log10 copies/mL by QPCR NA NA 8 mAbs NA NA NA 3.69 - ≥5.45 (Gefroh, Dehghani et al. 2014)
NA NA NA mAbs NA NA NA ≥4.2 (Miesegaes, Lute et al. 2010)
NA NA NA Not specified (1 molecule) NA NA NA ≥6.44 (Stuckey, Strauss et al. 2014)
PPV NA NA NA Not specified (2 molecules) NA NA NA 5.72 - ≥6.96 (Stuckey, Strauss et al. 2014)
Virosart CPV PPV NA NA NA Not specified (1 molecule) NA NA NA 6.00 (Stuckey, Strauss et al. 2014)
Planova BioEx MMV Approx. 6.0 Log10TCID50 /mL, 1.0% spike 10.0 – 49.7 50 3 mAb molecules (IgG1), pI 7.2-9.0 5.0 pH 4.0 – 8.0, conductivity 3.0-20.0 mS/cm 15 ≥ 4.8 - ≥ 5.6 (Strauss, Goldstein et al. 2017)
Viresolve NFP MMV 0.1% spike NA 904-1042 mAb NA pH 5.0, 50 mM acetate NA 4.07 (Gefroh, Dehghani et al. 2014)
Various small virus retentive filters (Planova 20N, Planova BioEX, Viresolve Pro, Viresolve NFP, Ultipor DV20, Pegasus SV4, Pegasus Prime, Virosart CPV, Virosart HF, Virosart HC) CPV 1:50 mixed spike with MMV and PPV Manufacturer recommendation 28.5-50 Prothrombin complex concentrate solution 1.7 pH 6.5 sodium citrate buffer and 15 mM NaCl No pause 0.7 - ≥6.9 (Nowak, Popp et al. 2019)
1:100 mixed spike with MMV 126-900 Human serum albumin solution 4.0 pH 5.5 MES buffer and 225 mM NaCl 0.1 - ≥6.8
MMV 1:50 mixed spike with CPV and PPV Manufacturer recommendation 28.5-50 Prothrombin complex concentrate solution 1.7 pH 6.5 sodium citrate buffer and 15 mM NaCl No pause 3.5 - ≥7.0
1:100 mixed spike with CPV 126-900 Human serum albumin solution 4.0 pH 5.5 MES buffer and 225 mM NaCl 2.5 - ≥7.2
PPV 1:50 mixed spike with CPV and MMV Manufacturer recommendation 28.5-50 Prothrombin complex concentrate solution 1.7 pH 6.5 sodium citrate buffer and 15 mM NaCl No pause ≥3.9 - ≥5.7
Various nominal pore size 15-20 nm filters (Planova 15N, Planova 20N, Planova BioEX, Pall DV20, Virosart HC, Viresolve NFP, Viresolve VPro) parvoviruses (B19V, BPV, CPV, MMV, PPV) NA 4-50 0-1200 Plasma proteins (Inhibitors, immunoglobulins, coagulation factors, and others) NA pH 4.8-8.4, conductivity 0.48-48 mS/cm NA Approx. 3.9 - ≥ 8.9 when intended for parvovirus removal; Approx. 1.5 to ≥7.5 if not specifically targeted for parvovirus (Roth, Dichtelmüller et al. 2020)
Not specified
MMV
0.5 – 1.0% spike
9-14
200-2500 g/m2
mAb >100 data points
7-17
pH 6.7-7.1, salt 0-150 mM
NA
>4
(Chen 2014)
Not Specified (3 commercial small virus filters) MMV 5.33-7.60 × 106 PFU/mL Various pressure reduction schemes 20 - 325 mAb (IgG1), pI 8.9 10 25 mM acetate, 175mM NaCl, pH 5.2 Various schemes 3.1 - ≥ 6.6 (LaCasse, Lute et al. 2016)