Living the Biopharma Dream in Lincoln

Room with a view: A curved bank of windows allows viewing from a common building corridor (and outside the building) inside the aseptic processing suite and its new Class 10 isolator.

Going Modular

Meagher’s vision has had technical grounding from engineering specialists. AES Clean Technology, Inc. (Montgomeryville, Penn.), with its expertise in modular cleanroom design and construction (think Cook Pharmica’s new Bloomington, Indiana biotech plant), and Biokinetics, Inc. (Philadelphia, Penn.), a specialist in biotechnology and pharmaceutical process systems, worked with Meagher even before funding was approved.

“We’ve been able to do a lot in a very small space,” says Grant Merrill, Director of Project Development for AES. “Dr. Meagher spent years on this layout—he came to [AES and Biokinetics] with a good plan which required only slight modifications. It’s a tribute to him.”

One thing the project had going for it was modular construction. AES’s system of cleanroom construction involves fabricating the architectural building blocks—walls, ceilings, air cavities, doors and windows—in the company’s Atlanta manufacturing facility but assembling them in the field. The process saves time but offers flexibility and precise finishes as well.

Modular made sense from a budget perspective. Academic projects require special considerations in regards to funding. Money does not come easily or quickly, and the purse strings are usually controlled by various committees. Once approved, there is no room for add-ons. “Ultimately, our contract was firm,” says Merrill. “The pressure was on us to stick to it.”

“I received a stick-built cost [estimate] about six years ago, and then later I developed a modular cost that was dramatically less,” Meagher says. “What was initially a $28 million project was trimmed down to an $11 million project, and with pretty much the same capabilities that we had outlined six years ago.” As it nears completion, the project is within budget.

3-D modeling was another key to success. Early on, Biokinetics had created preliminary designs of the building’s piping system, and AES had performed concept development of the clean space. When the project become official, Biokinetics took all of the design documentation and modeled the entire BPDF facility inside and out.

3-D modeling guided the design and construction of the BPDF—shown here, the entire facility including the basement clean utility area, first level cleanroom space, and upper level mechanical support mezzanine.

 Modeling meant that major wrinkles could be ironed out well before construction began. A case in point was the utility panel design, which required Biokinetics, with help from Central States Industrial Equipment and Service (Springfield, Mo.), to brainstorm how to transition process utility piping into the cleanroom environment by integrating utility stations into the wall system. Still, there are always issues that will arise in the field. Even with the entire piping system modeled, on-site engineers had to, for instance, figure out how to get a weld head on a WFI pipe with just six inches to work with. It wasn’t easy, says Leo Krieg, VP for Project Management. “Limited space was a general theme for the whole process,” he says. 

Back to School

AES and Biokinetics each had limited project experience in academia, and they both learned that such projects are not without their peculiar challenges. For one thing, administrators are not schooled in the ways of GMP. “The university, outside of the BPDF, had no basis for what GMP meant,” says Jennifer LoMonaco, Project Engineer for Biokinetics. “It was a constant educational process on all sides.”

Othmer Hall is home to a variety of scientific research labs, significant in their own right, that needed to remain operational and undisturbed by noise and vibration during the BPDF redevelopment. Universities also have their bureaucracies and regulations that must be met.

For example, the BPDF needed its own exhaust systems, but because of university architectural restrictions the main exhaust equipment could not be placed on the building’s roof. Once a suitable location was found, double-wall ductwork was routed through two stories of the existing facilities. Not only did UNL’s architectural review board need to sign off on this and all other aspects of the project, but the university’s own design and construction teams had to be consulted as well.

Some of the host building’s utilities were insufficient to meet the demands of the BPDF. Questions about chilled water purity and capacity meant that a dedicated chiller had to be located outside Othmer Hall to serve the process needs of the facility. “Here was another piece of equipment that had to go outdoors and be fully reviewed by the university,” says Kevin Koffke, Director of Engineering for AES.

In the end, this academic project was a valuable lesson for all involved. “We had to learn how to play in the university’s backyard,” says Koffke of AES.

Was it worth the effort? “It was a great opportunity for us to build something new,” says Biokinetics’ Krieg.

It’s a great showcase of the entire team’s talents, says Merrill. “If you walked into the facility from off the street, you’d think it was in the private sector,” he says.

That’s the whole idea, says Meagher. “We had to get over the stigma that we’re a university,” he says. “I wanted to make sure that this was legitimate in the eyes of industry where they’d say, ‘Oh my gosh. Yeah, this is real.’ ”

It’s real, but the problem with Meagher’s dream home is that it’s not the kind of place where he can put his feet up on the couch and relax. The work begins now, lining up clients to take up residence once commissioning and validation are completed next summer.