Flexible Pharma: Puzzling Out the Plant of the Future

Studies have shown that use of FlexFactory can allow companies to reduce plant costs from hundreds of millions to $25 million and project time-frames from five years to under one year. Hedging against risk will be critical, agrees Rakesh Kishan, director of the life sciences practice at UMS Advisory Group (Arlington, Va.). The key is not being tied to long-term ownership of assets that no longer have any use to the company. At the same time, he says, flexibility and scalability will continue to drive building use.

Despite ongoing industry restructuring, the top eight to ten Big Pharma companies still own about half a billion square feet of real estate, Kishan says, and, given a contracting economy and credit market issues, there will be fewer opportunities to shed excess, outdated capacity. Capacity utilization, now at 30% to 40% for the industry, will become more important, Kishan suggests, and more companies will choose to source key functions, such as API manufacturing and some clinical and R&D functions, off shore.

Economic realities should also stimulate interest in Toyota Production System methods such as OEE for both research and manufacturing facilities, and capacity utilization will be closely tracked, Kishan predicts.

GMP Gridlock?
Today, agility is thwarted, some observers say, by pharma’s dependenceon documentation. “The industry must come to grips with the paperwork machine that it has built up over the past few years,” says Ray Rogers, a principal with Tunnell Consulting (King of Prussia, Pa.). Paper and documentation issues have not kept up with the way that processes must fl ow, he says. As a result, a pharmaceutical facility “is not just a place that makes product, it’s almost like a documentation machine.”

“As an industry, we’ve messed up the business process around what we do,” says Genentech’s Petersen. “If you make a minor change in a piece of soft ware, for instance, it may take four hours to make the change, but you can count on it taking five weeks to get through the system,” he adds. “I’ve seen flow diagrams for one soft ware change that are over four pages long.”

Consultant Jim Agalloco agrees. “We make our own challenges and create our own barriers to innovation all the time in this industry,” he says, adding, “We’re very comfortable using not just last year’s but last century’s technologies.” Agalloco sees fully automated aseptic processing lines, like those applied in the electronics industry, as a very real possibility for pharma’s future, and a way of eliminating contamination by removing the operator from the process equation. The technology already exists to do this, he says, and regulators understand the benefi ts of automation. ”Someone just needs to have the foresight—or the audacity to say, ‘It’s time,’ ’’ he says. [More from Agalloco in this interview.]

The same conservatism is impeding agile concepts such as Quality by Design, and challenges will only increase as more companies outsource more functions off shore, predicts Prabir Basu, executive director of the National Institute for Pharmaceutical Technology and Education and a professor at Purdue who worked in the pharmaceutical industry for years. “The idea of QbD will resonate with people, but in many instances, applying QbD is like asking people to go from primary school directly into high school. A few students can do it, but most can’t.”

“More incidents like heparin are going to happen before things change,” Basu says. He would like to see equipment being designed for processes rather than the other way around, and to see pharma use more automated equipment. “If we can ever get to a stage like petroleum refining where operations are completely automated without human intervention, we can avoid human error. But right now it’s not happening because it’s difficult to justify the investment in multipurpose plants,” he says. [Read "Musings of a QbD Pessimist."]

Modularizing Construction and Data
Over the past few decades, modularization has allowed plant construction to become much more efficient, says Jacobs Engineering’s Bader. “Builders are getting better at designing equipment so you don’t have to take as much of it apart and the size of modules has increased,” he says. Bader recalls a recent project for Genentech in Singapore. The site was fairly close to the port where the modules had been shipped, so it was possible to put modules that were 25 feet by 100 feet—twice the width limit for transporting them via highway—onto barges to transport to the site.

Modular construction also allows the customer to be much more closely involved in the design phase, says Jacob’s Agarwal, which saves money down the line. He, too, recalls the Genentech Singapore project. The module design and fabrication for the process train was done in the shop in South Carolina before it was shipped. “All the customer input, walkthroughs and other work were done here,” he says.

As modular systems become more common, more vendors will offer pre-engineered projects, although whether they reduce costs or merely move some of the engineering costs into the equipment cost category remains unclear, Agarwal says. [Click here for more from Agarwal on modular construction and single-use equipment.]