For example, one company representative remarks, “We’re awash in data, but have no information.” That lament is what Alison Smith heard recently at a pharmaceuticals advisory board meeting of automation software supplier Aspen Technology Inc. (www.aspentech.com), Burlington, Mass., where she’s vice president of marketing strategy and research.
“This was a very apt statement. It applies to any environment in which technology has been deployed in the absence of an information design—and this is the case in most organizations,” Smith remarks. Noting that technology is “not the be-all and end-all,” she adds that industry is “awakening to the reality that there’s a need to design the information that’s ideally the end-result of technology as an enabler or competitive differentiator.”
Her pragmatic observation could even apply to regulations. Calling the U.S. Food and Drug Administration’s (FDA’s) former compliance-record keeping procedures “that validation monster,” Ed Lynch notes the agency’s change from that record keeping compliance regime to a risk-based, science-oriented approach. “The FDA has told us the emphasis is going to be on science. They realized they were more of the cause of the problems of pharmaceutical plants not being, as ‘The Wall Street Journal’ once said, as sophisticated as potato-chip plants [with respect to manufacturing science],” remarks Lynch, senior manager of automation and information management with drug maker Pfizer Inc. (www.pfizer.com), Groton, Conn
That compliance beast caused much investment in automation. “But with the new [FDA] approach, [even] the software may not be appropriate,” Lynch says. What evolves now, though, is using instruments to gather data and promote “quality by design.” That means companies model products and processes, and associated outputs, he remarks. “That’s what the focus would be—not, ‘Did you validate every logic path?’ ” Smith similarly notes that the industry is finding “that the ability to utilize the same process models in the lab and then transfer those same models into commercial operations—as the basis for variability control and process diagnostics—is very powerful.”
Coping with that particular cultural change in pharmaceuticals means overcoming the challenge of how companies configure automation systems, Lynch observes. Somewhat echoing Smith’s remarks, he says that, “generally speaking, this [change] has to come out of research, which is seriously pursuing this. We’re having meetings all the time about modeling and processes, to develop the science behind the process.”
Cost reduction pressures
Not surprising, especially in these economic days, there’s also increasing pressure for across-the-board cost reductions, says Smith. Two issues she says now facing branded-pharmaceuticals makers are patent expiration—“which a pharma manufacturer called ‘The Cliff’ ”—and new drug pipeline issues. Another big one is movement to biotechnology, she adds.
Pfizer is taking action already. Lynch, who notes that his company is moving into biotechnology, also predicts that Pfizer will “significantly reduce costs.” Perhaps that’s because “there won’t be the pressures to produce another blockbuster drug, because it’ll be easier to reformulate drugs.”
Leveraging science also means changing from batch to continuous processes. Though FDA likes batch, “it was sampled to death,” Lynch remarks. Lots of waste of materials at the beginning and end of each batch, as well as contamination risks and high costs from handling batches “many times,” also plagued batch.
But Pfizer pushes continuous processes for other reasons, too. Units have small footprints and are self-contained, and are thus more agile and lean. And, more importantly, the science is easier, sophisticated instruments can be used and monitoring is easier, Lynch says. How important is this switchover? “We’re looking at every new product and not assuming its [production is] batch.” That’s true cultural change in pharma.
C. Kenna Amos, email@example.com, is an Automation World Contributing Editor.
Aspen Technology Inc.