Pharmaceutical manufacturing has traditionally been more about high-volume chemical processing—not a historical playing field for Rockwell Automation. "But it's beginning to look more and more like exactly the sweet spot for Rockwell Automation," said Dave March, process capital productivity specialist for Rockwell Automation.
That sweet spot involves more localized intelligence, a high degree of interconnectivity and integrated architecture for an industry that is being forced to become more nimble, spending a lot less money to formulate factories and solutions much more quickly than it has in the past.
"The pharmaceutical industry is under stress," said March, as he opened today's Life Sciences Forum at Automation Fair 2010 in Orlando. But the speakers he gathered to speak at the forum are working on very innovative solutions to turn those stresses into challenges and challenges into opportunities.
{sidebae1}The presenters were Parrish M. Galliher, founder and CTO of Xcellerex, whose FlexFactory biomanufacturing platform is built around disposables technology; Guy Phillips, executive vice president of Intellergy, which makes systems to turn manufacturing waste into green products; Barry Holtz, president of G-Con, a DARPA-driven program that builds modular, flexible pharmaceutical manufacturing facilities; and Ralph Martel, CTO of Critical Path Institute, whose charter is to support the FDA's Critical Path Initiative to enable efficient and safe medical product development.
All the speakers pointed to what is a critical juncture in pharmaceutical manufacturing. "Getting the drugs to market—it's a tough business," Galliher said, pointing to an industry in which six of every seven drugs fail; it takes seven years to get from pre-clinical studies to market; and some $1 billion is spent, $850 million of which goes toward those six failing products.
"Traditional manufacturing facilities are incredibly burdensome," Galliher said, adding that they are prohibitively costly, have been built in the past 20-30 years, and have a four-year timeline to add new capacity. "Four years is an eternity in this industry." Many new production lines are not needed or are obsolete by the time they make it through validation.
For big pharma to get a facility built takes anywhere from six to eight years, according to Holtz. What needs to happen in a new paradigm, he said, in which pharmaceutical facilities are more flexible, not as capital-intensive, rapid to construct, very high-quality, and quick to reach compliance.
Both Galliher's and Holtz's companies have solutions to making more flexible production lines and facilities. The solutions go hand in hand with G-Con's modular, flexible facilities, in fact, making use of Xcellerex's disposables-based FlexFactory platform. In both cases, they're geared around pharma facilities that are flexible—can come up to speed quickly and can change products with relative ease.
A project that G-Con is building on the Texas A&M campus is the National Center for Therapeutics Manufacturing, which can accommodate as many as six stakeholders at a time, each working on a different pharmaceutical undertaking. It's based on closed manufacturing process, with work being done in pod clusters, with Rockwell Automation control systems in each pod. Because of its modular nature, the facility doesn't have to be shut down for the other stakeholders if one process is being changed, Holtz noted.
What is unequivocally the most compelling argument for this form of facility building is the time and money saved. A facility that would've taken years from start to finish will be completed in about seven months; and while big pharma spends $150 million to $600 million on egg-based influenza drug discovery, this facility, looking to develop vaccines from tobacco plants, is spending just $60 million. "This is a project that numbs the minds of big pharma because they can't think in numbers this small," Holtz said.
The pharmaceutical industry is spending an inordinate—and increasing—amount of money on R&D investment, Martel noted, spending about 19% of revenues annually. "Pharma is the most research-intensive industry that exists," he said. But in spite of a research investment that has only grown over the past several years, new molecular entity (NME) approval ratings have been declining over the long term. The approval of truly new drug formulations hit a high in 1996, Martel said, and has since fallen to about a third of their peak levels.
This did not go unnoticed by the U.S. Food and Drug Administration (FDA), which identified the widening gap between scientific knowledge and cures and called for a collective action to modernize tools in the industry. Thus the Critical Path Institute was developed in 2005 to help the FDA identify 76 opportunities in six key areas. What Martel focused on for the Automation Fair audience was one of those topics: Moving manufacturing into the 21st century, with 13 opportunities identified.
Martel highlighted particular successes his organization has had, through the consortia it has developed, to tackle the regulatory obstacles that the industry faces. A key goal has been to try to get approvals on a global basis rather than having to take separate steps through the FDA, Europe's EMA and Japan's PMDA. As March noted at the start of the session, "We are a regulated industry. I don't care if you have a Ferrari. You're not going to go real fast if there are a lot of stop signs." The pharmaceutical industry must work in concert with the FDA and other agencies to tackle manufacturing concerns, he added.
Addressing another concern, Phillips made a strong case for Intellergy's solution to waste management. Using a 100-year-old steam reforming technique (technology originally developed to process coal into gas for lighting streetlamps), Intellergy is able to completely eliminate any kind of waste from a pharmaceutical facility—from syringes to dead animals—by using high-temperature steam to break down chemical bonds. It's a process that also has no emissions.
Pharma must rethink the way it is operating its facilities in a number of ways to become more flexible, more efficient and faster-to-market. "We have to do things quantitatively and qualitatively different," Phillips said. And as March noted, the changing life sciences industry has great potential for process automation to help with those advances.
Early adopters, Galliher said, are mid-tier biotech companies, which have dollars to spend, but do not have the legacy of traditional technology to feel guilty about walking away from. Also likely to take advantage are vaccine companies that are in the process of switching technologies from egg-based to cell-culture methods, and biosimilar companies, which have limited money to invest in capacity, but understand competition. "Notice big pharma is not on this list," Galliher said, noting that very few are making investments in flex capacity.
