ABSTRACT
Aseptic processing gains an increasing importance within the biotech industry due to the fact that cold sterilization by membrane filtration is the only option to sterilize biological solutions. Any heat treatment would destructively affect the drug product and target protein. To assure that the sterile filtered product maintains its sterile state, disposable process solutions are used increasingly to process or store the resulting filtrate. In addition, there are certain processes where sterile filtration is not possible, as it would remove the drug substance. In those instances, such as cell therapies or certain viral product in (oncolytic) vaccines, the entire process must be handled in an aseptic fashion to mitigate foreign contaminants.
