Viral contamination is a risk for all biotechnology products. Establishing robust viral removal/inactivation steps mitigates the risk of adventitious and endogenous viral contamination and is essential for ensuring the safety of gene therapy products. AGTC employs helper virus, a recombinant herpes simplex virus type 1 (HSV), to manufacture therapeutic AAV vectors.
Recent studies have shown that viral retentive filtration is one of the most robust steps in removing all types of viruses. In order to ensure the removal of endogenous and adventitious viral contaminants, AGTC is developing a viral filtration step after the downstream column purification.