The Process and Analytical Technology Initiative (PAT) was a major topic of discussion at the 2008 Interphex trade show held last week in Philadelphia. Technology suppliers argued that pharmaceutical manufacturers’ long-standing reluctance to change production processes is preventing many of them from realizing the benefits this initiative can bring.
Though it has been around since 2004, many life sciences companies are still trying to familiarize themselves with PAT—the Process Analytical Technology Initiative .
This program, sponsored by the U.S. Food and Drug Administration (FDA), is supposed to present a framework for deploying IT in ways that will speed up the process of manufacturing new pharmaceutical products without sacrificing quality or running afoul of FDA reporting requirements.
PAT was a major topic of discussion at the 2008 Interphex trade show held the week of March 24
Technology suppliers were especially talkative about PAT, with most arguing that pharmaceutical manufacturers’ long-standing reluctance to change production processes is preventing many of them from realizing the benefits new technology can bring.
“The history of the industry has been that the FDA has required companies to document their manufacturing processes and then be able to show that they actually followed those processes, and any subtle change to a process required a re-validation,” said Frank Offenbacher, life sciences marketing manager, Honeywell Process Solutions .
Given that history, Offenbacher said, many pharmaceutical manufacturers are hesitant about interjecting new technology into their processes out of fear that it will bring new FDA scrutiny.
Bob Lenich, director of data integration for Emerson Process Management , said some pharmaceutical manufacturers have even balked at installing new devices to collect data about production processes. “They are concerned that the data will show problems—because that’s how you improve things by uncovering problems.
But they concerned about what the FDA will say when they see all that data laid out in front of them.”Though they understand the genesis of these fears, technology suppliers say they are unfounded, primarily because the FDA is sponsoring PAT and is actively encouraging manufacturers to study its guidelines to learn how to incorporate technology into their processes while maintaining regulatory compliance.
Some vendors say economic conditions ultimately will force the manufacturers to take that leap. “This industry has been driven by research and development, with the emphasis on developing new blockbuster drugs,” Offenbacher said. “Manufacturing was a secondary concern and the few points of margin to be gained by improving those processes weren’t really worth it.”
Now, he said, with patents on new drugs expiring much quicker and insurance companies are squeezing manufacturers to hold down prices on those drugs, there is more incentive to streamline manufacturing processes. Thus, there should be more interest in PAT—which offers a framework for creating technology infrastructures that support efficient design, analysis, and control of manufacturing processes.
Interphex was the place to see PAT-compatible solutions. For instance, Honeywell was displaying its POMSnet manufacturing control system. This solution, which Honeywell created specifically for the pharmaceutical industry, combines manufacturing execution system (MES) functionality with distributed control system (DCS) capabilities. The end result, according to Offenbacher, is a solution that can help pharmaceutical manufacturers “improve their compliance position by reducing the possibility of errors occurring in their manufacturing processes.” At the same time, he said, the cost maintaining consistent product quality should go down significantly.
Emerson demonstrated how components in its Delta V digital automation solution can be used to speed the time it takes to turn cell cultures into commercial drugs. In partnership with bioreactor maker Broadley James, Emerson has created a virtual plant model that can simulate the growth of a cell culture at 1,000 times the normal speed. This allows for seeing how a product will react in the production process, and making any necessary changes to that process, before actual production begins. “This will not only make production go faster, it also will improve yield,” Emerson’s Lenich said. “We already have shown that we can cut a 22-day product development cycle in half.”
Other vendors exhibiting at Interphex included JustSystems and Parsec Automation .
JustSystems demonstrated a solution called xfy for Batch Process Management, which allows manufacturers to turn recipes and instructions for manufacturing processes into XML-based documents that can be stored and reused any number of times.
Parsec Automation unveiled the latest version of its TrakSys real-time performance management suite, which contains enhanced capabilities for auditing production processes and tracking key performance indicators.
