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The collaboration’s enhanced data exchange combined with advanced analytics are expected to reduce raw material variability and improve biomanufacturing performance reliability.
In a March 11, 2019 press release, GE Healthcare announced a digital data exchange collaboration program with Amgen, which will include advanced data analytics to increase the understanding of the relationship between raw material variability and process performance during the manufacture of biologic medicines. As a part of this initiative, GE Healthcare and Amgen will be installing a seamless connection for data transfer between GE Healthcare raw material manufacturing sites and Amgen’s process development center in Cambridge, MA.
The ability to detect and monitor raw material variability through data integration will be an important step to ensuring consistent and predictable biomanufacturing performance, GE noted in the press release. Data insights can be used to drive process and product improvements and reduce the potential for supply disruptions.
“We know that slight changes in raw materials can have a significant impact on product attributes of biotechnology medicines,” said Rohini Deshpande, vice-president, Attribute Sciences at Amgen, in the press release. “At Amgen, we seek to understand our end-to-end supply chain, from raw materials to finished products. By analyzing data directly from the manufacturing site for raw materials, we can have a better understanding of the effect of variations in raw materials on our products.”
“This project is a perfect example of the type of collaboration we want to drive together with the biopharma industry, pushing the boundaries of manufacturing efficiency and performance reliability even further,” said Olivier Loeillot, general manager, BioProcess at GE Healthcare Life Sciences, in the press release. “The data exchange capabilities that we are introducing can have a huge positive impact on the biomanufacturing operations, and this is only the beginning of our digital journey.”