DNA Removal By Depth Filters in Bioprocesses

摘要

The FDA through CBER has recommended that DNA in final product dosage forms should not exceed 100 pg per dose. Host cell DNA can contaminate the culture fluid as a result of release by lysed or dead cells. In some cell culture clarification systems, centrifugation or tangential flow filtration (TFF) may be used as a primary clarification step. Both of these technologies are shear intensive and can increase cell lysis, resulting in increased host cell DNA contamination. The presence of contaminating DNA early in a process creates the possibility for carry through during downstream purification. It is therefore important to remove as much DNA as possible during the early stages of purification.