The American Healthcare Leader (AHL) recently sat down with Melissa Seymour, Vice President of Global Quality Control at Biogen, to discuss their iQC project and how it is changing the way they do business. iQC is an initiative aiming to standardize procedures and prepare the company for rapid growth.
This project came as a direct result of Biogen’s work as they were beginning to develop a new drug Aducanumab (currently in Phase 3 clinical studies), a potential treatment for Alzheimer’s disease. More than 5 million Americans suffer from Alzheimer’s disease and if the drug is approved, Biogen needs innovative technology to help them produce enormous amounts of product quickly and accurately, while still meeting compliance standards. Melissa says, “this could truly be life-changing for millions of patients.”
As Melissa recognized the need for a system that would reduce errors and improve efficiency at the same time, the iQC project was established. She commented, “Our goal with iQC is to provide increased testing capacity and the ability to reduce cycle times as well as lower system, equipment, and infrastructure maintenance costs.”
One of the exciting new technologies the iQC project uses is the Rapid Micro Biosystems Growth Direct™. Biogen’s lab utilizes the Growth Direct to cut down on the time needed to detect bioburden from the previous three - five days (traditional) to less than 48 hours (time to results), for a potential time savings of up to 60%. Melissa explains, “Implementation of these types of technologies can reduce errors and increase turnaround times while also ensuring compliance.”
Learn more about Biogen’s iQC project and how they plan to use new technologies (like Growth Direct) to advance their business, by checking out the full article here.
To learn more about how Biogen validated the Growth Direct for in process bioburden check out the following posts: