Site transfer and process validation in case of Herceptin API

Area of Science:

• Biopharmaceutical Manufacturing
• Process Validation
• Analytical Chemistry

Background:

• The manufacturing process for Herceptin Active Pharmaceutical Ingredient (API) was transferred from Genentech to Roche's Penzberg site.
• Equipment differences necessitated process adjustments and thorough revalidation.

Purpose of the Study:

• To validate the transferred Herceptin API manufacturing process at the Roche Penzberg site.
• To assess the comparability of the API produced by the original Genentech process and the modified Roche process.

Main Methods:

• Downscale studies examined chromatography column lifetime and purification capacity for virus removal/inactivation.
• Production scale investigations focused on the consistency of the Roche process.
• Analytical methods were employed to demonstrate API comparability.

Main Results:

• The revalidation process confirmed the robustness of the manufacturing steps.
• Downscale and production scale assessments indicated consistent process performance.
• Analytical testing demonstrated that the Herceptin API produced by Roche is comparable to that produced by Genentech.

Conclusions:

• The manufacturing process transfer and revalidation were successful.
• The Roche Penzberg process consistently produces Herceptin API comparable to the Genentech process.
• This ensures a reliable supply of high-quality Herceptin API.