Viral Clearance Using Capto Adhere ImpRes

Extracted from Multimodal Chromatography (PDF), GE Healthcare, 2013

The capability of Capto adhere ImpRes for viral clearance from MAb was tested with two model viruses: the enveloped RNA retrovirus, MuLV, and non-enveloped DNA parvovirus, MVM. Mab samples partially purified by protein A affinity chromatography were spiked with virus stock solution and were then applied to Capto adhere ImpRes in bind/elute and flowthrough mode. Eluted fractions were analyzed for virus titer by endpoint titration and large-volume plating. Capto adhere ImpRes showed efficient viral clearance in both bind/elute and flowthrough mode (Table 4.11). The log10 virus reduction factor was approximately 5.0 in bind/elute mode for both MuLV and MVM. In flowthrough mode, log10 virus reduction factor was > 4.0 for both MuLV and MVM.

Table 4.11. Viral reduction factor (log10) of MuLV and MVM purified using Capto adhere ImpRes in bind/elute and flowthrough mode

 

Minimal log10 viral reduction factor
Process purification mode MuLV MVM
Bind/elute1 4.98 4.95
Flowthrough2 > 5.0 4.0

1 Bind/elute conditions: phosphate/citrate, pH 7.9 (binding); phosphate/citrate + 45 mM NaCl, pH 5.4 (elution).

2 Flowthrough conditions: pH 5.5, 19 mS/cm conductivity

Materials

     
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