Table 5.

Robustness of Sindbis virus inactivation with respect to caprylate concentration, protein concentration, pH and incubation temperature during the caprylate‐inactivation step of the Gamunex® process

Parameter	Parameter level	Log10 Sindbis inactivation
Caprylate	18 mm	6·0
concentration	15 mm	5·9
	11 mm	5·9
Protein	1·1%	5·8
concentration	1·2%	6·0
	1·5%	5·8
pH	4·9	6·3
	5·1	6·0
	5·3	6·3
Temperature	25 °C	6·0
	20 °C	5·8

One parameter was varied at a time, while all others were held at the production‐operating setpoint (shown in bold; 20 mm caprylate, pH 5·10, 1·2% protein, 25 °C). Each value represents the mean of three determinations.