Enhanced data exchange combined with advanced analytics are expected to reduce raw material variability
GE Healthcare announces 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 innovative 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. Data insights can be used to drive process and product improvements and reduce the potential for supply disruptions.
This collaboration program with Amgen represents the next step in optimizing these digital capabilities to help biomanufacturers gain more understanding of the impact that the processes used to manufacture raw materials have on biomanufacturing process performance.
“We know that slight changes in raw materials can have a significant impact on product attributes of biotechnology medicines. 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,” said Rohini Deshpande, Ph.D., Vice President, Attribute Sciences at Amgen.
“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. 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,” said Olivier Loeillot, General Manager, BioProcess at GE Healthcare Life Sciences.
In May 2018, GE Healthcare announced a major manufacturing transformation project in Logan, Utah using GE’s Brilliant Manufacturing software tools that combine lean and advanced manufacturing with software analytics.