ASTM E2888-12

This practice assures 5 log10 inactivation of nondefective C-type retroviruses, which are endogenous to murine hybridoma and CHO cells and are potentially present in the production stream of biopharmaceutical processes that use rodent derived cell culture.

1.2 The process parameters specified in this practice consistently assure 5 log10 inactivation of murine retrovirus by adjusting the pH of a process solution after initial affinity capture chromatography purification.

1.3 This practice is applicable to mAb, IgG fusion, or other recombinant proteins produced from rodent cell lines (for example, CHO or murine hybridoma), which do not target retroviral proteins. Additionally, the low pH step is performed on a cell-free intermediate, post initial capture using protein A chromatography.