Viral Clearance Using Capto™ Adhere

Viral clearance using Capto adhere was tested with two representative model viruses, Minute Virus of Mice (MVM) and Murine Leukemia Virus (MuLV). Monoclonal IgG₁ was purified from CHO cell supernatant on MabSelect SuRe. Buffer concentration and pH of the elution pool were adjusted to typical process conditions. The conductivity was adjusted to 10 and 30 mS/ cm by addition of NaCl. The samples were spiked with virus stock solution and were then applied in flowthrough mode on Capto adhere. The log₁₀ reduction factor at 10 mS/cm was 5.8 logs for MVM and 4.5 logs for MuLV. Even at high conductivity (30 mS/cm), where traditional ion exchangers do not work, the log reduction factor was 5.9 logs for MVM and 3.6 logs for MuLV (Table 4.5).

Table 4.5 Capto adhere viral clearance[1]

Virus	Conductivity (mS/cm)	Log10 Reduction Factor ± 95% confidence limit
MVM	10	5.8 ± 0.3
MVM	30	5.9 ± 0.3
MuLV	10	4.5 ± 0.4
MuLV	30	3.6 ± 0.4

¹ Study performed at NewLab BioQuality AG, Germany. Test conditions were: pH 6.75, temperature 22 °C, experiments performed in duplicates.

For more information on this example, see data file 28-9078-88, “Capto adhere.”