Facility of the Year Winner Roars Back to Life
CUSTOMER: Genentech, a member of the Roche Group, is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions.
ARCHITECT: Fluor Corporation
In addition to winning the overall 2016 Facility of the Year Award (FOYA), the project was recognized as the category winner for Process Innovation. Process innovations include:
- Eight 25K Liter Production Bioreactors
- Buffer concentrates, buffer bags, and in-line buffer dilution systems
- Large-diameter chromatography columns (1.8M) with centralized resin slurry and delivery systems for column packing
- 1,368-sq.-ft. and 2,736-sq.-ft. final purification UFDF systems
This is DPR’s second time winning a FOYA award for a Genentech project. The first was in 2007 when Genentech’s Oceanside Facility was named the overall 2007 Facility of the Year Award winner.
World-class team delivers—and redelivers—largest drug manufacturing facility of its kind for Genentech
Ingenuity, flexibility and a strong spirit of collaboration by a world-class project team were the key drivers behind a pair of projects for Genentech, a member of the Roche Group. The team successfully delivered, and then returned to service, one of the largest biotech fermentation facilities of its kind in the world located in Vacaville, CA.
Encompassing 450,000 sq. ft. of manufacturing and support space, the Cell Culture Biologics Drug Substance Plant 2 (CCP2) facility employs some of the largest scale cell culture drug substance production equipment in the industry. That includes eight 25 KL production reactors that vastly expand the facility’s fermentation capacity, nearly 100% closed-system processing, automated batch recipes, and many other innovative features. At peak production, the facility is equipped to provide oncology products for about 500,000 patients annually.
Originally completed in 2007, shuttered in 2010 and then returned to service in late 2015, the CCP2 facility took a circuitous route to fulfill its mission of producing lifesaving pharmaceuticals for a global marketplace. It offers proof that in the world of business, a successful outcome is not always the result of an entirely straightforward journey.
The journey began in 2004, when Genentech commissioned the CCP2 project to add manufacturing capacity to its Vacaville facility. It was needed to meet increased market demand—expected to triple over the next five years—for two major oncology products. DPR completed the first project within an aggressive, 15-month construction schedule, obtaining a temporary certificate of occupancy 13 days ahead of plan in June 2007.
The business climate changed shortly after the project was completed, however. By 2009, as the products were nearing licensure, Roche acquired Genentech, and the decision was made to fulfill market demands for those drugs elsewhere. The CCP2 facility was shuttered, but the owner had the forethought to leave it in a returnable state with major utilities and infrastructure still intact.
RETURN TO SERVICE
The owner’s forethought proved pivotal. By fall 2013, the demand for Roche biologic products had changed. Roche and Genentech moved to return CCP2 to service again to meet worldwide demands. They assembled a seasoned design and construction team for the new return-to-service (RTS) expansion project and a new fast-track licensure date was set for May of 2016.
The CCP2 RTS project capitalized on lessons learned from the original CCP2. Team members co-located on site, employing innovative project management strategies to achieve the project’s aggressive goals. The team’s mission statement was “One Team, One Goal.” Among the highlights:
- Integrated Schedule: A highly integrated schedule (directly with Genentech’s master production schedule), sometimes detailed down to hourly activities, was a key tool for coordinating design, construction, shutdown, startup, operation and validation activities.
- Quality Control: “Build it right the first time” was the mantra, backed by a rigorous and proactive quality control program. The RTS project team turned over 53 systems in just 4-and-a-half-months, taking a page from the original CCP2 project that turned over 341 systems in just 10 months.
- Minimizing Operational Impact: Avoiding disruptions to the existing plant was paramount for both projects. There wasn’t a single unplanned shutdown.
- Focus on Sustainability: Delivering a highly sustainable project was a key goal. Sustainable highlights included waste and water minimization, energy reduction and reduction of greenhouse emissions.
The team was able to start engineering runs in January 2015, 53 days early and only 16 months after project approval.
Choosing Vacaville as the site for CCP2 leveraged the existing infrastructure for CCP1 for plant utilities/offices/labs as well as savings in headcount. As a result, these shared services saved the owner an estimated $50 million, according to Mike Marston, who served as project executive for DPR and was recently announced as a new DPR Bay Area business unit leader. “This truly was a project of perseverance and a testament to the terrific amount of drive, innovation and creativity from everyone who worked on the project,” he said.
In September, the efforts of the project team were recognized when the International Society of Pharmaceutical Engineers awarded the CCP2 manufacturing facility and RTS project its coveted Facility of the Year Award for 2016. The honor acknowledges the facility’s innovative approach to process and equipment design, as well as the project team’s creativity, innovation and perseverance on the highly challenging job.