Author: Gröner, Albrecht; Broumis, Connie; Fang, Randel; Nowak, Thomas; Popp, Birgit; Schäfer, Wolfram; Roth, Nathan J.
Title: Effective inactivation of a wide range of viruses by pasteurization Document date: 2017_11_16
ID: w19hl2vs_9
Snippet: High-titer virus stocks were spiked into aliquots of at least two different lots of production intermediates and the pasteurization step was performed according to manufacturing specifications in laboratories specially designed for handling viruses. To assess robustness in general, studies at or outside the manufacturing specifications were performed: 1) decreased temperature (588C), 2) increased stabilizer concentration (up to 110% after spiking.....
Document: High-titer virus stocks were spiked into aliquots of at least two different lots of production intermediates and the pasteurization step was performed according to manufacturing specifications in laboratories specially designed for handling viruses. To assess robustness in general, studies at or outside the manufacturing specifications were performed: 1) decreased temperature (588C), 2) increased stabilizer concentration (up to 110% after spiking), 3) product intermediate without stabilizers, and/or 4) stabilizer excipient composition without plasma protein.
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