By Cenk Undey, Amgen
In drug development and manufacturing, variability in raw materials presents high risks to the success of our processes and our products. When raw material variability issues arise, manufacturers and suppliers must address them immediately by analyzing data and determining the root cause. Sometimes these issues can be fixed quickly, and other times they can be more serious, creating a significant setback to your development and manufacturing timelines. This is why understanding, monitoring, and controlling raw material variability across the biopharmaceutical value chain from raw material suppliers to patients is critical. However, doing so depends on how a company’s raw material data is collected, shared, and analyzed.
At Amgen, a Supplier Relationship Excellence (SRE) program was designed to open the lines of communication with suppliers and create a feedback loop where data can be shared to better understand operational performance. In doing so, Amgen has advanced several digital and predictive technologies across the value chain that have contributed to the success of SRE and the exchange of electronic data (eData) with suppliers. This includes establishing smart contracts, developing data exchange standards, using predictive models to anticipate issues or identify improvement opportunities, and leveraging artificial intelligence tools and technologies.
While the bio/pharma industry has historically lagged when it comes to digital technologies, adopting a digital transformation such as this for the collection and analysis of raw material data, along with other critical data throughout the value chain, could modernize drug development and potentially revolutionize patient care.