ISPE Honors Genentech As 2016 Facility Of The Year

Sept. 21, 2016
The International Society for Pharmaceutical Engineering recognizes Genentech’s Cell Culture Biologics Drug Substance Plant Two.

The International Society for Pharmaceutical Engineering (ISPE) names Genentech 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. Established in 2004, The Facility of the Year Awards (FOYA) recognize projects utilizing new technologies to improve the quality of products, reduce the cost of producing high-quality medicines and demonstrate advances in project delivery.

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, according to ISPE. The upgrade of the large scale, 450,000 square foot facility was reportedly completed two months ahead of schedule and resulted in significant savings in capital.

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, according to ISPE.

Process innovations reportedly 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.

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