Site transfer and process validation in case of Herceptin API.

The manufacturing process for Herceptin Active Pharmaceutical Ingredient (API) was successfully transferred from Genentech to Roche, Penzberg site. Although the transferred process in principle remained the same, some changes had to be introduced mainly due to the different equipment installed in the Penzberg facility. As a consequence, a thorough (re-)validation of the process was performed. At the downscale level, the lifetime of the chromatography columns as well as the capacity of the purification process for virus removal and virus inactivation were examined. At the production scale, the consistency of the Roche process was investigated. As a result of the process validation, the Genentech and the Roche process were found to be comparable. In particular, the analytical comparability of the Roche and Genentech API could be demonstrated.