Process management: Life sciences companies have performance improvement down PAT
Jim Fulcher, contributing editor -- Manufacturing Business Technology, 5/26/2008 8:23:00 PM
As the definition of “manufacturing process” widens to include the supply chain, manufacturers must adopt technologies that assure appropriate quality outcomes in real time. This is particularly key in the life sciences industry, where the Food and Drug Administration (FDA)—among other regulatory bodies—acts on behalf of consumers.
Until recently, once the FDA approved a product and its manufacturing processes, there was over reliance on manufacturers to audit production and weed out defects—often leading to stock-outs, shortages, and a rise in the number of drug recalls, says Justin Neway, Ph.D., executive VP and chief science officer with Aegis Analytical, a supplier of manufacturing performance management software and services to the life sciences industry.
Now the FDA is putting more pressure on the pharmaceutical and biotech industries to enhance their operations through use of process analytical technologies (PAT) that require data collection, data access, and data analysis systems.
A critical success factor for all process improvement initiatives, including PAT, is on-demand access to all the data and data types in the operational data stores of manufacturing IT infrastructure systems, which allows multidisciplinary team members to extract information in context to understand cause-and-effect relationships, Neway says.
To gain that capability, life sciences manufacturers such as Baxter, Berlex, Eli Lilly, Genzyme, Wyeth, and others use the Discoverant manufacturing process management software suite from Aegis to improve operations efficiency and quality compliance.
“Through its PAT and quality by design [QbD] initiatives, the FDA has created a regulatory framework that encourages the use of innovative technology to deepen manufacturing process understanding,” says Neway. “During process development and in commercial manufacturing processes, Discoverant can help companies reduce process variability, improve yields, and reduce batch failures. The real-time data access platform can push data to a wide range of useful tools.
Leveraging the capabilities of their process analytical technologies and other process improvement tools is considered vital to compete and comply in the life sciences environment.
New York-based Bristol-Myers Squibb, for instance, is using Discoverant to achieve greater process understanding and control during process development for new products. Executives note that Discoverant fits well into the company’s strategy for implementing PAT and QbD.
In addition, enhancing data analysis capabilities during manufacturing process development for a new drug will help the manufacturer meet regulatory expectations that are critical to the approval and launch of new products.
Alison Smith, a director with Boston-based AMR Research, says competition will continue to drive innovation in life sciences manufacturing operations.
“Margins for big pharmaceutical companies have been so high that those companies have gotten away with having high scrap rates and low throughput,” Smith says. “But as drug patents continue to expire and competition from generic drug manufacturers rapidly increases, these companies realize the significant need to substantially cut costs and innovate as a means to become more competitive. There’s clearly a need for this type of product, the technology is mature, and the client list of companies using Discoverant is growing.”
