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By Dave Harrold
A dozen years from now—2020—Brazil, China, India, Indonesia, Mexico, Russia and Turkey could account for as much as one-fifth of global pharmaceutical sales, according to a recent PricewaterhouseCoopers report, “Pharma 2020: The Vision—Which Path Will You Take?” PricewaterhouseCoopers also reports that 58% of multinational pharmaceutical executives said the center of gravity is shifting to Asia Pacific.
Richard Spoor, senior vice-president of global procurement at Merck & Co., Whitehouse Station, N.J., says, “We’re seeking to outsource non-core functions—those where external manufacturers may have greater expertise, and also have the ability to deliver a particular active ingredient, excipient or even a final product more efficiently than we could.”
Janet Woodcock, deputy commissioner of the U.S. Food and Drug Administration (FDA), has alluded to one of the reasons: Pharmaceutical manufacturing is not “state-of-the-art.” She went on to describe what is causing many drug manufacturers to incur manufacturing costs that are as high as its R&D investments.
According to Woodcock, manufacturing utilization rates are as low as 15% at some companies due mainly to inefficient batch production processes. Woodstock added that some companies are wasting as much as 50% of what they produce; product scale-up activities remain unpredictable; some companies’ global operations are fragmented; and too many companies don’t know the causes of production failures.
The handwriting is on the wall. Like it or not, where and how we manage batch processes will differ dramatically by 2020.
Many batch management innovations were initiated by people working in the highly regulated biopharma sector. Ironically, at the same time, the sector lags behind others in implementing these improvements. (See “Is PAT a Silver Bullet,” June ’08, p.55.)
From a controls, automation and integration perspective, among the most significant of these efforts is the ANSI/ISA-88 and -95 series of standards and references.
Bob Lenich, data management services director with Emerson Process Management, observes, “Certainly the adoption and use of past innovations and solutions will continue to represent good engineering practices in the future. However, where and how the biopharma sector manages batch processes in the future requires that it embrace the industry’s Operational Excellence and FDA’s Process Analytical Technology (PAT) initiatives to seek out and adopt even more innovative batch management solutions that reduce batch review and release cycle times; increase use of integrated recipes and automation to reduce unintentional SOP errors and batch processing problems; reduce recipe-to-recipe and batch-to-batch variability; and increase standardiz ation to support technology transfer and help ensure regulatory compliance.”
When you add these goals to the likelihood of increased contract manufacturing from the burgeoning drug manufacturing business overseas, and factor in recently introduced prescription drug “pedigree” laws, it may appear that the pharma industry is facing insurmountable odds—until you learn that some pharmaceutical companies are close to achieving these goals.
Each year, the International Society for Pharmaceutical Engineering announces the winners of its Facility of the Year Awards. In 2007, Cook Pharmacia in Bloomington, Ind., won for Facility Integration, and Genentech’s Oceanside, Calif., facility won for Project Execution. Both used advanced approaches. Cook’s project transformed an abandoned television factory into a scalable, tightly integrated contract manufacturing facility, while Genentech’s “design-build hybrid” project used ISA88 to develop an automated recipe-level process control system. Genentech applied the FDA’s 21 CFR Part 11 regulation to develop a paperless, dock-to-dock system that includes assembly of electronic batch-end records and electronic signatures. What Cook and Genentech’s accomplishments reveal is that, when it comes to batch management, innovation is quite doable.
At a recent control and automation user conference, David Kircher, manager of global manufacturing execution systems (MESs) for Abbott Laboratories, Abbott Park, Ill., described how Abbott implemented a highly automated, tightly integrated batch management solution at its facility in Barceloneta, Puerto Rico. He reported there was considerable discussion at Abbott about the need for an MES at the Barceloneta plant, but there also were some common misapprehensions about MESs, such as:
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