A New Paradigm for Quality Oversight in the Production of Biological Products
Part of the BTEC Fall 2019 Seminar Series
Friday, Nov. 15, 2019
BTEC Room 135
Open to the public
Chief Quality Officer, Biogen
Modern analytical technologies are redefining the way that the quality of biological products is assured. Currently, main quality checks rely heavily on the consistent execution of a validated process and conformance to prescribed testing of either the drug substance or drug product, supplemented by discrete in-process testing. Progress in advanced process controls, novel analytical technologies, real-time measurements, and effective management of large data sets offer new possibilities for how the oversight of quality control can be executed. This oversight can shift from a heavy reliance on end-process testing to an integrated approach that allows for faster product release and dynamically adjust to normal process variability to accurately assess impact or adjust. This presentation will discuss how these approaches can be practically and effectively integrated into a process resulting in a better assurance of quality along with a more efficient system. There are numerous advancements in analytical technology that are now allowing testing continuously and at more informative locations in the manufacturing process. These new approaches will allow for better responses to unanticipated events in processing and more rich analysis for investigations and corrective actions. Additionally, the use of predictive analytics, based on the wealth of information that is now possible, will shift monitoring of Quality performance toward leading indicators, compared to the lagging indicators mostly employed at present. Finally, these new approaches could be critical in allowing a reduced regulatory burden associated with change management of continuous improvement in either manufacturing processes or the associated analytical systems.