METHODS OF EVALUATING CELL CULTURE ADDITIVES

摘要

The present disclosure shows, unexpectedly, that variations in cell culture performance in large-scale cell culture systems such as, for example, those used in commercial manufacturing processes, in some instances, can be attributed to often subtle variations among shear-protectant additives used during cell culture. Assessing the quality of shear-protective additives using such large-scale systems, however, is inaccurate, time-consuming and costly. To solve the problem identified, the present disclosure provides methods and compositions for evaluating the suitability of shear-protectant additives without resorting to large scale cell growth and/or protein production tests.

主权项

1. A method for evaluating sample variations of a shear-protectant additive, the method comprising the steps of:
(a) producing, in a solution that comprises viable cells and a shear-protectant additive at a concentration of about 0.01 g/L to about 10 g/L solution, bubbles in an amount sufficient to cause a greater than about 5% drop in cell viability relative to initial cell viability; (b) measuring one or more cell performance parameters of the cells to obtain one or more cell performance values; and (c) selecting the shear-protectant additive if the one or more cell performance values is comparable to one or more reference values.