In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|September 21, 2016
Genentech Wins ISPE’s 2016 Facility of the Year Award
Author(s)BioPharm International Editors
Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.
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The International Society for Pharmaceutical Engineering (ISPE) announced Genentech (a member of the Roche Group) as the Overall Winner of the 2016 Facility of the Year Awards (FOYA) program at ISPE’s Annual Meeting & Expo in Atlanta, Georgia, the organization announced in a Sept. 20, 2016 press release. Genentech won the award for the upgrade of the company’s Cell Culture Biologics Drug Substance Plant 2 (CCP2), a large-scale, 450,000-ft2 facility located in Vacaville, California.
“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, in the press release. “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.”
According to the release, Genentech was driven to revamp the original CCP2 facility to support product supply to patients of two significant oncology products whose market demand has tripled in recent years. The manufacturing process uses some of the largest-scale cell-culture drug substance production equipment in the industry, including eight 25,000-L bioreactors, 1.8-m diameter chromatography columns, and seven clean-in-place skids serving upstream and downstream areas. Process innovations included high titre yields at this large bioreactor scale 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 were significantly expanded in scope to reduce product production cost. The project was completed two months ahead of schedule and resulted in significant savings in capital ($50 million).
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