Methods for viral inactivation and other adventitious agents

摘要

The invention provides for methods of viral inactivation using high temperature short time (HTST) treatment and adjustment of various parameters such that generation of precipitate and depositions of precipitate are reduced and/or minimized.

主权项

1. A method for inactivating virus or adventitious agents in mammalian cell culture media while the media maintains suitability for cell culture, said method comprising (a) adjusting pH, limiting the total amount of calcium, and/or limiting the total amount of phosphate in the cell culture media prior to high temperature short time (HTST) treatment such that the formation of complexes comprised of calcium and phosphate is suppressed, and (b) subjecting the cell culture media to HTST treatment to inactivate the virus or adventitious agents, wherein the cell culture media comprises
(i) a calcium concentration of 0 mM to 0.5 mM and a phosphate concentration of 0 mM to 4.5 mM; (ii) a phosphate concentration of 0 mM to 1 mM and a calcium concentration of 0 mM to 2.75 mM; (iii) a pH of 5.0 to 6.9 and a total amount of calcium and phosphate of less than 10 mM; (iv) a pH of 6.4 to 7.4 and a phosphate concentration of 0 mM to 0.5 mM; (v) a pH of 6.4 to 6.7 and a phosphate concentration of 0 mM to 3 mM; (vi) a pH of 6.4 to 7.2 and a calcium concentration of 0 mM to 0.5 mM; or (vii) a pH of 6.4 to 6.7 and a calcium concentration of 0 mM to 1.3 mM.