A small scale purification facility was used to supply Phase III and launch material for GARDASIL®. A larger facility was required to meet the expected demand for the product. A key component of the licensure for this facility was the demonstration of the comparability of the process and the drug substance produced in this in this new facility. We present the framework and strategy used to demonstrate comparability, and the results that clearly show the product made in the new facility is comparable to that in the launch facility.