Real-time data analysis keeps Amgen a step ahead

Framed by a landscape of stainless-steel lab equipment, the giant flat-screen monitor in Amgen Inc.’s pilot plant displays seemingly mundane line graphs and such. It almost seems like a waste of a high-definition television.
Put a member of the Amgen Process Development team in front of it, though, and the monitor becomes a touch-screen delight.
What staff members see flowing across the monitor are the vital signs of one of the most painstaking manufacturing processes – the making of biopharmaceuticals. They see big-picture data analysis in real-time, something not unusual in most manufacturing but unique in biotechnology.
Workers can use the dashboard monitor setup to drill down for information by simply touching data points on the colored graphs, for example.
When information indicates adverse variations in production, the display will prompt workers to monitor the news. If needed, corrections in the production process can be made.
Success of the product, or the batch, is crucial considering the investment in raw materials, labor and technology.
“One lot is a 45-day process. It’s a long, engaging operation with many, many steps,” explained Kimball Hall, vice president of Amgen’s Rhode Island operations, where the company produces Enbrel, a drug for rheumatoid arthritis, psoriasis and other immune and inflammatory diseases.
This monitoring tool – less than 2 years old – relies on a sophisticated data-integration system that takes into account more than 500 variables throughout Amgen’s mammoth West Greenwich plant. Facets of the system anticipate process trends, known as weak signals, which allow workers to respond before a serious problem arises.
Since introducing these innovations in monitoring, key metrics at the plant have improved by more than 50 percent and produced a savings of $1 million to date, the company reported.
Hall said during the first year of using the system the plant experienced a 100 percent batch success rate based on more than 100 batches. The success rate is now at 98 percent in its second year. The industry standard is roughly 90 percent, Amgen officials said.
The innovation comes at a time when the Rhode Island plant is retrofitting the facility to become a multiproduct enterprise. The success of this technology at the Rhode Island plant will not only benefit their facility but will be adopted globally by the company, said Hall.
She credits Amgen’s Process Development unit for the success. Using science, technology and engineering, Process Development works to make Amgen’s manufacturing unit more efficient and consistent.
“We invest a great deal of money in each manufacturing procedure. So having a tool like this is important for a greater assurance of success,” explained Doug Inloes, executive director of the Process Development unit.
The real-time picture provided by the touch-screen monitor wouldn’t be a reality, he said, without a two-year-long investment in creating a “plant data warehouse.” The virtual warehouse automatically integrates data from multiple system sources, on demand and within seconds, thus allowing for analysis of reliable and up-to-date information.
Creating this single source for information was an information technology feat, as it involved funneling information from hundreds of data sources in one direction and then translating that data to provide relevant feedback.
Previously, when process issues occurred, staff would have to gather and analyze data from multiple sources. It was a task that took up to five workers and several months to complete.
The next step for the process development team was to develop a system to use the improved data integration to develop novel monitoring approaches.
By automatically confining a large number of variables into a select few, they were able to help pinpoint how performance is changing across batches of product.
What was needed, though, was a way to do the same thing in real-time, not after the fact.
The monitoring tool pinpoints where the product is in the process from any given point. Thus, if an adverse issue is identified on the dashboard, staff can quickly observe from which process step, and within which piece of equipment, the issue is taking place. With a few taps on the touch screen, staff can obtain specific measurements for further evaluation.
“If there is a malfunctioning sensor or probe, the ability to identify it in real-time and make needed changes has great benefit to us,” said Cenk Undey, senior principal engineer in Process Development.
After a nine-month process, Amgen was able to make the monitoring live and viewable on the manufacturing floor.
“There was one case where there was an issue with one of the filters showing increasing pressure,” explained Undey. “We used the system on the fly to understand the root cause and address it.”
He said that adjustment meant improving the manufacturing capability within a month. In the past, it could have taken months.
Undey said the data integration coupled with the dashboard display capability is “one of a kind” in the industry.
As a 24/7 operation, communication is critical in shift changes. So having concrete trends to hand off from shift to shift has been a major improvement, Undey said.
Approximately 30 percent of Amgen’s Rhode Island-relevant operations are now using the system. Within a year, the company plans to have the entire plant on board and it won’t stop there. Within the next two years, the innovation will be deployed at Amgen locations globally. •

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