A quality-assured gene amplification assay system (PCR) for use on an industrial scale - a proposal for validation

摘要

In the pharmaceutical industry the manufacturing process is tightly regulated and controlled. The same is true for the virus inactivation and removal procedures, which are an integral part of the manufacturing process. Nevertheless, the starting material may be contaminated above a critical level such that standard inactivation and partition procedures cannot cope with the viral load. With IQ-PCR, a critical viral load of the starting material can be detected and excluded, thus resulting in a quality-assured starting material for further processing. Therefore, the potential viral load of the starting material-is limited to below what can be removed and inactivated during manufacturing, thus improving substantially the safety comfort.