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The latter means big opportunities in China and India particularly, she suggests. “The big pharma companies are looking to expand their footprints to reach these new populations.” That expansion via outsourcing through joint ventures “is critical to agility, productivity and efficiency—and basically, access to markets.”
One serious issue, though, is quality control of products. That’s generated “a tremendous amount of concern,” Smith states. “At AspenTech, seven of the top 10 pharma companies are on our executive board. There’s a lot of concern about how to build [U.S. Food and Drug Administration (FDA)] compliance into these [foreign-produced] products.” That has market consequences, Smith says, because the cost of business has been artificially low. “Costs will rise when more inspectors and [compliance] systems are put into place in China.”
These compliance concerns cross the branded-generics boundary too, especially for generics producers, as being one of the most important factors for process improvement. But with brandeds and generics, Smith notes that outsourcing appears to be the most important factor.
While generics focus on becoming leaner, brandeds continue to collaborate with small biotech companies, Smith observes. “That’s the growth engine, where all the research on new molecules and therapies comes from.” While the big guys focus on outsourced innovation, the challenge becomes, she believes, “How do you take it from research into development and then bring it to market? And how do you support the FDA’s QbD (quality by design) standards?”
These challenges awaken pharmas to the need to collect more data from processes. “There’s suddenly a tremendous interest in capturing the data and doing meaningful analysis, and then tying that back to the pilot plant or late-stage development,” Smith observes. There’s definitely a place for automation, she adds, “in advanced process control, simulation, historians and more.
John Blanchard sees three areas in which life sciences seem to be deploying the most automation technology. Those include collaborative production management (CPM), process analytical technology (PAT) solutions, and integrating disparate systems and databases, says Blanchard, principal analyst with the CPG and life-sciences group of ARC Advisory Group Inc. (www.arcweb.com), Dedham, Mass.
According to a November 2008 ARC report, “Pharmaceutical, Biotech, and Medical Devices Business Challenges and Strategies: ‘Adapt or Die,’ ” by Blanchard and Janice Abel, another ARC principal analyst, “the pharmaceutical industry is the leading purchaser” of CPM software and services. “This general space is sometimes also referred to as manufacturing execution systems (MES) or manufacturing operations management, or MOM, he adds.
Ensure quality
Regarding PAT, the FDA defines it as a system for designing, analyzing and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials as well as processes, Blanchard states. Its goal? “To ensure final product quality.” Instrumentation and process-control-system technology suppliers are responding quickly and developing many application-specific, PAT-based solutions for both drug development and commercial manufacturing, he finds.
As Blanchard says, the industry is now defining the infrastructure, automation architecture and technology platforms required to change from a science- to a business-based organization. And because of new business and regulatory requirements, he suggests that among other things the industry must do, it must foster continuous improvement, enable better process understanding and justify innovation to improve process design.
C. Kenna Amos, This email address is being protected from spam bots, you need Javascript enabled to view it , is an Automation World Contributing Editor.
Aspen Technology Inc.
www.aspentech.com
ARC Advisory Group Inc.
www.arcweb.com
