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Genentech Plans September Debut of New $240M Rx Fill/Finish Plant in Oregon

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Genentech is months away from starting operations at a new $240 million pharmaceutical-fill/finish plant it recently built in Hillsboro, Ore., designed to accommodate its needs and those of its partner-turned-acquirer, Roche.

Genentech's Hillsboro Fill/Finish Facility, which the company calls HFF, is now carrying out validation testing for its packaging lines, required in order to obtain the US Food and Drug Administration approvals needed to start receiving bulk shipments of drugs the company produces in South San Francisco, Calif., then carrying out final processing and packaging of those drugs.

These drugs, which include the recombinant growth hormone Nutropin, non-Hodgkin's Lymphoma treatment Rituxan, and cancer drugs Avastin and Herceptin, are part of the product line Roche agreed to buy earlier this month when it acquired the South San Francisco, Calif., biotech pioneer for $46.8 billion.

"The goal for that is to get those [packaging lines] up and running by September of 2009," said Joe Miller, principal architect in Genentech's design-engineering group, addressing attendees last week at a session discussing the three-story, 296,000-square-foot facility.

"We do want to start shipping it out there [Hillsboro] for packaging, so inspection will go up there, as well as labeling and packaging," Genentech said. "By the end of this year, those components will be already validated and licensed and ready to start operations."

Miller said the plant's filling lines "are just really going through operational qualifications. They're still doing startup [tests]," while "we just finished air balancing in our fill and finish facility, so we know that's set.

"It's a little bit more complicated with the isolators, cause there's much more linkage now between the air balancing and the actual isolator operation, so they're fine tuning those," Miller said. "They are starting to do some initial test runs. I've seen they've been filling vials, and they're actually doing some test runs through the inspection."

Miller spoke March 18 during a discussion session on the project held as part of Interphex 2009, the pharmaceutical manufacturing conference held at the Jacob K. Javits Convention Center in New York. Miller and two architectural principals from project — Andrew Cunningham and Jim Gazvoda from Flad Architects of San Francisco — detailed the thinking behind the new HFF, as well as the effort to design and construct the facility.

The HFF consists of five buildings — the main administrative offices, the GMP-manufacturing building, a utility building, a GMP warehouse, and a distribution center, all occupying 12.5 acres of a 75-acre site about 13 miles west of Portland.

Inside the manufacturing building, Genentech has built out two freeze dryers, with room for two additional freeze dryers should production needs warrant them; as well as two filling and packaging lines — one liquid, one either liquid or "lab like" products — and shell space for a third filling line that "we anticipate may be a syringe fill line."

HFF expects to reach its full staff capacity of 300 employees by 2015 for the just-in-time facility, which is designed to produce 20 million vials of drugs annually at sizes ranging from 3cc to 100cc; as well as cut manufacturing costs by minimizing on-site inventory space.

Formal planning for the project began in 2006, nearly three years before Genentech agreed to sell its remaining 44-percent share to Roche, creating the nation's seventh-largest pharmaceutical company with combined revenues of about $17 billion, and a combined workforce of about 17,500 people.

Because Roche has had a stake in Genentech for almost two decades, the companies have worked closely on a number of ventures. A supply agreement between the companies, for example, committed Genentech to producing 25 percent of the Avastin, Rituxan, and Herceptin sold by Roche worldwide.

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Roche was also interested in seeing a new facility emerge that could take the place of a similar plant it designed at the same time in Basel, Switzerland, in the event it were to be shut down for repairs or maintenance.

'Diversity, Spread Out Risk'

To satisfy the agreement with Roche, the plant has 25-percent additional capacity designed into it.

"This facility can serve as a backup to the Roche facility, and the Roche facility [can serve] as a backup for the Genentech facility," Miller said. "Both companies were looking at technologies that were compatible with each other's" — though not costlier custom technologies.

Miller added that Genentech also had its own interests in mind in developing the HFF — namely a need to build production capacity projected to be needed in 2015, and a desire to do that by spreading out a manufacturing operation mostly focused till now within its South San Francisco headquarters campus.

"Operations were developed and spread out through the site, so you don't really have operational efficiencies when you have to do a lot of transportation of raw materials, finished product, and you're doing multiple handling steps," Miller said. "You certainly need work-in-progress staging at these handoff points.

"The major driver was really risk mitigation," Miller recalled. "We're in a very active seismic zone. We have a lot of older facilities, and to strengthen the business continuity of our supply chain … there was a conscious effort to look at our current operations and say, 'How do we diversify, and spread out our risk, and not be so California-based any more?'"

After a search, Genentech found the location it wanted in Hillsboro then worked out a series of tax breaks with the state and Washington County. The state agreed to spend $4.8 million, including $2 million from the Governor's Strategic Reserve Fund, toward infrastructure repairs and worker training.

"This is a great company with a history of strong growth, and it will be a jewel in the crown of Oregon manufacturing," Gov. Ted Kulongoski declared in 2006 when he announced the project.

The Washington County deal was even sweeter: Genentech qualified for the county's Rural Strategic Investment Program because its site lay outside Hillsboro's urban growth boundary. Under "rural SIP," Genentech agreed to pay property taxes assessed on the first $25 million of its project costs, while the county agreed to raise its property tax exemption threshold by 3 percent every year thereafter, in return for Genentech paying a $500,000 "community service" fee. The biotech giant also received property-tax incentives on its specialized equipment that extend 15 years after the end of construction.

Genentech worked with an engineering firm to define the project's elements and to arrive at a fixed budget, then brought in a construction team to execute detailed design and construct the building shells. The biotech then worked with a process-engineering team to design the elements of Hillboro's utilities and equipment building.

While the HFF's five buildings were originally planned to be built sequentially, late in the design process Genentech added a distribution center that it insisted should be built first, and within 16 months, changing the sequence of construction from counterclockwise to clockwise.

Because the all-important, three-story manufacturing building was in the middle of both sequences, Miller said, "it allowed us the time to really spend doing the detailed engineering for the process equipment and the utility system."

Genentech wanted that building built within 24 months; it was completed just over two months ahead of schedule with more than 520 construction workers on site during the peak of the work, Cunningham said. The 21.7-month timeframe reflects an overlap between the 7.9 months it took to perfect the design, followed by 19 months of construction.

Key to that success, Cunningham said, was the decision by Genentech and its design and construction teams to hold 17 standing weekly meetings and "multiple meetings beyond that."

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"I think in any one week, I may have attended about 20 meetings myself," Cunningham said.

Gazvoda said Genentech had assigned a leader to oversee every functional and technical area of the HFF.

"Important right up front, through preliminary engineering and preliminary design, we worked collaboratively as a team. Everybody got and met together regularly. We all understood how each discipline affected the other's discipline," Gazvoda said.

He said the meetings served to help the group, which got as large as 250 consultants and team members, by prioritizing issues and pinpointing which ones needed immediate answers. Once it got to final engineering, then we broke into silos. We needed focus. And when you push and you drive a process as hard as we did, you have to have energy in those areas where it counted most."

The design and construction professionals, he said, capitalized on their vendors, who in turn drew upon the know-how of their equipment vendors. "They provided ideas right up front to all of us, so that we could coordinate the building plans, the organization, and the utilities and services that were being planned," Cunningham said.

He added that architects from Vlad strove to improve a conceptual plan sketched out by Genentech and another consultant, fleshing out a facility design based on the flows of the processes to be carried out at the plant. At the manufacturing building, formulations will be made on the top floor, followed by filling and inspection on the second floor, and packaging on the ground floor, with space designed within for some additional storage if Genentech needs it someday, though not months of inventory.

Those plans, in turn, were reviewed for quality control and cost; as part of those reviews, "we had to cut out thousands of square feet to bring this building back into a target area where it would fit with Genentech's budget," Cunningham said.

After years of producing its drugs within several buildings scattered through its headquarters campus — a inefficient byproduct of Genentech expanding gradually there, adding space over time as its needs grew — the biotech giant wanted its new facility to be as compact as possible: "We were given the purview to try to consolidate this area into as tight an area of the site as we possibly could," Cunningham said.

"By the end of the day, it became quite self-evident that the solution we ended up with was really probably the most effective and most sufficient layout that was going to give Genentech a consistent flow around the project site, but also satisfy its just-in-time delivery requirement, but not having flows go backwards and forwards across the building, potentially having cross-contamination," he added.

Genentech's desire for compactness, he said, was also evident in the main administrative building, which also houses not only the quality control labs, but the employee training center, and an employee cafeteria whose amenities include a fireplace.

"It was important for Genentech. As a company, they have a culture of really taking care of their employees, [hence] having facilities on the site where they'll be working long hours, and where they could actually have areas of refuge from the manufacturing area, where they could go and relax, Cunningham said. "They were really looking to try to break the paradigm of, what's a manufacturing building all about? How do you build community? How do you build team within that building? We were looking for those public spaces to help bring people together."

Adding to the uses of the administrative building, he said, offered another benefit: reducing the cost of the manufacturing building, which because of its functions and equipment was already the costliest building within Genentech's Hillsboro campus.

The cleaning and storage area for tanks undergoing maintenance was also moved outside of the manufacturing building, to the warehouse building "where we had more room to clean and then store the empty tanks ready for shipping" back to the manufacturing facility.

Cunningham said the skill of the various teams involved in construction reflected a shared sense of the facility's purpose — a purpose Genentech sought to convey by having the director of its Hillsboro operations, Barry Starkman, discuss the project with the teams.

"He got up and explained what the mission of Genentech was, what this facility was going to do, the fact that they were producing drugs to cure people from cancer. I think that was probably one of the big 'Aha!' moments in pulling this team together. There was a single goal about what we were trying to do here," Cunningham said. "It wasn't about just building a building. It was about something much bigger than that."

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