Stories

Biotech Manufacturing: Making the Impossible, Possible

The project achieved Substantial Completion two weeks ahead of a 15-month schedule.
The increased production capacity makes it the largest cell-culture manufacturing facility in the world.
Part of the expansion took place in part of an operating facility and had to be performed without disrupting operations.
Over 300 different subsystems needed to be turned over and validated in less than two years.
The project achieved Substantial Completion two weeks ahead of a 15-month schedule.
The increased production capacity makes it the largest cell-culture manufacturing facility in the world.
Part of the expansion took place in part of an operating facility and had to be performed without disrupting operations.
Over 300 different subsystems needed to be turned over and validated in less than two years.

DPR completes 450,000-sq.-ft. expansion project on Genentech’s Vacaville campus, making it the largest cell-culture biotech fermentation facility in the world

Building upon a more than 10 year relationship with Genentech, DPR, with the help of 120 companies, subcontractors and vendors, achieved what some believed to be impossible. Working more than three million hours in 15 months, Genentech’s Cell-Culture Plant Two (CCP2) team added a new manufacturing facility and infill, expanded the existing warehouse and spine, and doubled the size of the central utility plant—all on a fully functioning campus without a single interruption— and achieved Substantial Completion and Temporary Certificate of Occupancy (TCO) two weeks ahead of schedule.

“I’ve been a building inspector for 30 years, and when I started onsite, I honestly didn’t think they would make their deadline,” said Leon McNeil, building official, project inspector for the city of Vacaville. “But as the project unfolded and started to come together, I saw the power of teamwork. It was impressive.”

Team Players

Client: Genentech

Architect: Fluor Corporation

At a total of 450,000 sq. ft, the expansion of Genentech’s facility in Vacaville, CA, included a new manufacturing facility and infill, an addition to the existing warehouse and spine, and doubling the size of the central utility plant, all on a fully functioning campus without a single interruption. The project, which achieved Substantial Completion and Temporary Certificate of Occupancy two weeks ahead of a 15-month schedule, will increase the campus’ production capacity to 344,000 liters, making it the largest cell-culture biotech manufacturing facility in the world upon licensing and will produce biotechnology drugs for serious and life-threatening diseases, including cancer. To meet the aggressive June 27 contractual delivery date set in late 2005, when DPR started as the general contractor on the project, the CCP2 team knew the delivery process had to be different.

“Even with crews working three shifts around the clock for a year, we knew that we had to start the validation process immediately or the schedule wouldn’t be met,” said Rishard Bitbaba, project manager for DPR. “Genentech and the entire project team, which included around 120 different companies, subcontractors and vendors, collaborated to create processes and systems that allowed us to turn over the facility system by system, piece by piece rather than waiting until it was fully completed for Genentech to begin the validation process.”

With more than 300 different subsystems to turn over and validate in less than two years, it was critical that the team understood how one system impacted the other and had a strong understanding of the validation process itself.

“We looked at everything from a purely mechanical, process and electrical perspective and developed a phasing plan where the systems were turned over based on Genentech’s manufacturing needs not the construction need,” said Mike Marston, project manager for DPR. “The process science drove the sequencing.” As a result of the “rolling turnover,” there was a 70 percent overlap between construction crews and Genentech staff validating systems, all working side by side to meet the schedule. This helped to create a highly integrated team and collaborative effort, which included training the validation staff to work within a construction environment.

In addition to the accelerated schedule, part of the expansion took place in part of an operating facility and had to be performed without disrupting ongoing operations in Cell-Culture Plant One. The central utility plant (CUP) affected all 26 of Genentech’s systems. DPR doubled the size of the plant, as well as expanded the main spine that included upgrading all of the systems and tying into a couple of the buildings’ services, without a single unplanned shutdown over the two-year project.

“We also built a new shipping and receiving area without impacting any of the deliveries,” said Ray Trebino, project manager for DPR. “It’s unbelievable what can be accomplished when everyone is truly working together as a cohesive team.”

“When we started CCP2, it was like taking a drink out of a fire hydrant with the amount of information that was pouring out,” said George Pfeffer, project executive for DPR. “It seemed impossible. But what it really came down to was commitment, collaboration and communication and a true understanding of what the customer needed.”