Effective inactivation of a wide range of viruses by pasteurization

Gröner, Albrecht; Broumis, Connie; Fang, Randel; Nowak, Thomas; Popp, Birgit; Schäfer, Wolfram; Roth, Nathan J.

The critical manufacturing variables for the pasteurization step include temperature, time, and the composition of the product intermediate (including stabilizers and protein composition). These critical variables are tightly controlled, monitored, and verified by quality control practices during the full-scale commercial manufacturing process and were also similarly controlled during the scale-down virus validation studies. For each manufacturing process, the robustness of the pasteurization step for virus inactivation was evaluated in two ways: 1) by demonstrating the susceptibility of a diverse variety of enveloped and nonenveloped viruses to the heat treatment procedure and 2) by demonstration of virus reduction under conditions set at or outside the limits of the manufacturing process where virus inactivation kinetics and log reduction could theoretically be impeded (lower temperature and/or higher stabilizer concentration).