By Dave Kolwyck, Director Materials Science, Biogen
The inherent unpredictability of biologic drug development continues to present the industry with new challenges when it comes to ensuring consistent process performance. As next generation manufacturing platforms become implemented in biomanufacturing networks, real-time inline monitoring will be a critical element of maintaining control in bioprocessing. When we understand more about material attributes, we can then use that information to drive appropriate and dependable critical process control requirements.
It is for these reasons that Biogen’s raw material characterization team decided to explore several novel strategies that could potentially increase their process and raw material control and optimize communication of data throughout the supply chain. As a result, they were able to better understand sources of variation in their raw materials, thus enhancing and streamlining Biogen’s manufacturing process control strategy.