ISPE announced Genentech (a member of the Roche Group) as the Overall Winner of the 2016 Facility of the Year Awards (FOYA) program. The winner was revealed at ISPE’s Annual Meeting & Expo in Atlanta, Georgia.
Genentech was driven to revamp their existing Cell Culture Biologics Drug Substance Plant 2 (CCP2) located in Vacaville, California, to support product supply to patients of two significant oncology products whose market demand has tripled in recent years. The upgrade of the large scale, 450,000 square foot facility was completed two months ahead of schedule and resulted in significant savings in capital ($50M).
“The Genentech CCP2 facility project exemplifies the FOYA program commitment to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers,” said ISPE CEO and President John Bournas. “Genentech instituted the newest process technology, global standards of best in class compliance standards, and sustainability goals while maintaining the shortest fast track schedule possible to ensure patient product supply.”
Genentech’s manufacturing process utilizes some of the largest scale cell culture drug substance production equipment in the industry, including 8 x 25,000 l bioreactors, 1.8 meter diameter chromatography columns, and 7 CIP skids serving upstream and downstream areas.
Process innovations include high titre yields at the largest bioreactor scale used in the industry, and the complete conversion of downstream processing and all fluid handling systems to support the recovery of this higher titre output compared to the original installation’s lower titre design criteria. Equipment redundancies and labor sharing were balanced between CCP2 and CCP1, and the facility and process automation was significantly expanded in scope to reduce product production cost.
Established in 2004, The Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches.