Meet Genentech – 2016 FOYA Winner for Process Innovation
Genentech, a member of the Roche Group, is the 2016 ISPE Facility of the Year Award Winner for Process Innovation for their Cell Culture Plant 2 (CCP2) Manufacturing Facility and Return to Service (RTS) project located in Vacaville, CA.
Genentech is a leading biotechnology company that discovers, develops, manufactures, and commercializes medicines to treat patients with serious or life-threatening medical conditions. As one of the largest cell culture manufacturing facilities in the world, CCP2 is an integral part of the Genentech/Roche supply chain, providing medicines to patients with serious and life threatening conditions. At peak production, this facility can provide oncology products to over 500,000 patients annually.
The CCP2 Project began as a five+ year project, with preliminary design in 2004, to add manufacturing capacity for two of Genentech’s major Oncology products. Licensure was expected in 2009, which made for an incredible goal given its size and complexity. However, by 2009 the decision was made that the capacity of the CCP2 was no longer needed and was shut down in 2010. Fortunately, the company had the foresight to leave the facility in a returnable state, keeping major infrastructure intact. By late 2013, the market had changed and the supply demand of Roche biologic products inventory was forecasted to reach critically low levels. As a result, the decision was made to fast track the restart of the CCP2 plant with RTS required by late 2015.
A combined team of engineers, contractors, and operational personnel was formed to execute the CCP2 RTS project with a focus to:
- Modify the plant to meet new GSP requirements
- Adapt to changes in compliance landscape
- Integrate sustainability directives
- Improve Environmental Microbial Control (EMC)
- Incorporate new MCS Automation changes.
By including state-of-the-art technology to shared labor costs between Cell Culture Plant 1 (CCP1) and CCP2 to equipment redundancy that will nearly eliminate downtime, CCP2 will achieve its goal of reducing the cost of life saving drugs to patients. This goal was paramount to the initial CCP2 project and also to the RTS project. From the onset of the ground breaking, to the final validations and completion of qualification lots, the teams who worked on the CCP2 projects showed a tremendous amount of drive, ingenuity, creativity, and perseverance to overcome challenges to bring this facility online.
ISPE congratulates the Genentech team for their achievements and their win for Process Innovation. Learn more about Genentech’s CCP2 Manufacturing Facility RTS project.
Join ISPE and prominent industry leaders as we recognize the 2016 Facility of the Year Awards (FOYA) Category Winners for their innovation and creativity in pharmaceutical and biotechnology facility design, construction and operation at the FOYA Banquet on the evening of Tuesday, 7 June 2016 in North Bethesda, MD during the ISPE/FDA/PQRI Quality Manufacturing Conference.