METHODS OF PRODUCING HIGH TITER, HIGH PURITY VIRUS STOCKS AND METHODS OF USE THEREOF

摘要

The purity and titer of virus stocks used for virus clearance studies have a significant influence on study outcome, and impact how well the scale-down model represents the production-scale process. Impurities in virus stocks are particularly important in the testing of small virus retentive filters because these impurities may cause a filter to foul prematurely, leading to underestimation of the true throughput capability of the filter and consequent inappropriate sizing of the production scale unit. In addition, impurities can also affect the levels of virus clearance observed by altering the fouling mechanisms and subsequent fluid passage through the virus filter. Described herein are methods for making, producing and using high purity virus stocks having high titer.