Pharmaceutical manufacturing is undergoing a major change as the industry shifts from using single-product, stainless steel processes to multi-product facilities with single-use technology. The emphasis on delivering the right medicine to the right patient at the right time requires facilities to become more agile and improve the flow and visibility of data from R&D through commercial processing. Manufacturers must invest in robust—and standardized—automation and data management to make the most of new processing technologies, provide products that meet patient needs, and increase profitability.
How can life science companies increase flexibility in manufacturing without sacrificing operational efficiency? The answer lies in standardizing automation through the use of the ANSI/ISA-88 (S88) standard to create modular recipes and blocks of information that can be copied or reassembled. This eliminates the need to reinvent the wheel for each new process or modification, allowing for reduced recipe development cycle times while upholding Good Manufacturing Practice (GMP) compliance.
The S88 framework, a major topic presented this week at the Emerson Global Users Exchange, helps thread together islands of data and is being used to standardize operations and reduce some of the customization still seen across the industry. Johnson & Johnson manages more than 200 product families, 2,000 SKUs and 1,800 raw materials, and there must be coordination between all of these elements, explained Doug Gray, director of standards, analytics and visualization for the company. “How do you take all these external and internal processes and drive a product that is cost-effective to produce and meet the customers’ and the patients’ expectations?” The S88 standards are the keys to success in product lifecycle management, he said.
Big Data management is a priority for Johnson & Johnson, which began employing S88 principles even before they became effective in 1995. The visibility of data provides a window into the plant at any given moment, which ultimately allows for better scientific understanding, said Marc Hooybergs, senior director of global execution systems at Johnson & Johnson. “The operator or the process engineer will have the data while manufacturing, not after the step is done, so they can make decisions in real time,” he said, adding that in the R&D arena, tech transfers can be up to 40 percent faster with 50 percent less effort to validate.
The next generation of biomanufacturing facilities is already in operation and benefitting from S88 principles. Amgen’s commercial facility in Singapore is a multi-product biomanufacturing plant featuring single-use bioreactors, continuous purification and real-time analytics. The standard has helped to streamline tech transfer and improve integration (minimizing the manual transfer of data), according to Greg Bischoff, director of information systems at Amgen.
Opportunities still exist to advance automation for life sciences with standardization, and Emerson Process Management continues to make strides in improving how recipe and data management systems are operated and integrated. “The Emerson team has supported Amgen with a really strong S88 development, understanding the functionality and different levels of S88,” Bischoff said. “If we can parlay that to a broader scale across the industry and really start leveraging the structure, it will benefit us as a collective industry.”
