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_10
Snippet: The laboratory scale of the pasteurization step was representative of the production scale for each specific product, as it met the respective process variables of the manufacturing scale, for example, temperature (60 6 18C), incubation time (10 [11] hours), stabilizer composition (product specific composition of excipients), and concentration (commonly target of 100% of stabilizer used in the manufacturing process by adjusting the stabilizer con.....
Document: The laboratory scale of the pasteurization step was representative of the production scale for each specific product, as it met the respective process variables of the manufacturing scale, for example, temperature (60 6 18C), incubation time (10 [11] hours), stabilizer composition (product specific composition of excipients), and concentration (commonly target of 100% of stabilizer used in the manufacturing process by adjusting the stabilizer concentrations taking into account the virus spike volumes). The virus reduction factors (RFs) demonstrated are, therefore, predictive for the manufacturing process scale.
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