One of my mantras when consulting to the pharma industry is, Go out and learn what others have done with the same processes. Food and beverage uses many of the same processes as pharma OSD, while fine chemicals is strongly parallel to pharma API, and the brewing industry would be a very useful lesson for pharma biotech. So start small, look for low-hanging fruit, set aggressive time scales, be prepared get help from external experts, look outside the pharma industry and work hard to ensure that you stay close to a corporate sponsor.
Despite their reflexive resistance, Benton adds that some folks from the major pharmaceutical firms want to learn about PAT and use Broadley-James bioreactor system. Were seeing a lot of interest from the automation guys in the pharma plants, says Benton. However, many of the scientists dont quite grasp it yet, and so theyre still skeptical.
Because its beta test is still running, Benton adds that final results arent available yet. There were also some challenges with getting six sensors installed on the small, 7-liter vessels, which threatened to change the tests characteristics. However, the expected efficiencies and benefits generated by Broadley, Emerson and Novas partnership likely will be groundbreaking. Were looking at substantially reducing the usual 18 months spent on process development, getting more and better quality data that can be used for all ranges of scales, and securing accurate predictions of actual performance if we change the control on a particular variable.
Onto the Plant Floor
Though some drugmakers have PAT in their R&D facilities, moving it into actual processes is another ball game entirely. Pedro Hernandez, Ph.D., QbD and PAT leader at Wyeths (www.wyeth.com) Pharmaceutical Development Center in Puerto Rico and New York, explains that his company began this migration three years ago by acknowledging at all levels that Wyeth needed QbD and real-time monitoring.
We needed and used champions and end users in our organization who committed to saying it was OK to make time for PAT, says Hernandez. Then we drafted feasibility plans, brought in IT, developed new applications, conducted monitoring and statistical analyses, implemented new processes, trained staff, presented internal case studies, and moved toward continuous improvement. The case studies showed people that investing in PAT was worthwhile because it will give us better knowledge and control of our unit processes. You could see the lightbulbs go off in their heads. It's about culture and philosophy, as well as tools and technology. It's a commitment and recognition that QbD, PAT and achieving continuous quality assurance is everybody's responsibility.
As a result, Hernandez adds that Wyeth presently uses PAT to monitor several unit processes like blending, milling, drying and compression across multiple products.
Jim Montague is Controls Executive Editor.
|For expanded coverage, videos about Broadley-James, audio interviews, and PAT stories and other resources from Controls sister publication, Pharmaceutical Manufacturing, please visit and read the online version of this article on its landing page at www.controlglobal.com/PAT|
Piloting a PAT Project
Its not easy to get a process analytical technology (PAT) model and project up and running, but there are a few basic steps that pharmaceutical manufacturers or other process users can take to make sure they implement the most useful solution for their application, according to several veteran phamaceutical manufacturers, process control engineers, system integrators and equipment suppliers.