A highly automated, continuous method for developing active controllers of product quality attributes in early phase clinical development
May 6-11, 2018
The biotherapeutics industry is aggressively targeting increases in product quality. It has been recently suggested that a 10x increase in robustness of product quality will be required in the next 5-10 years to meet the changing market forces of our industry1. This step-increase in quality will likely only be achieved by actively controlling product quality attributes in bioproduction processes, using techniques like model predictive control (MPC)2. Adoption of MPC of product quality attributes in bioproduction processes has been somewhat sluggish, despite the recent introduction of enabling technologies, such as aseptic auto samplers. One barrier for adoption of MPC is the current difficulty involved in developing MPC controllers. This difficulty stems from the fact that critical to quality process technologies like MPC must be adopted early in the drug development process to achieve consistent clinical material throughout the drug development process. There remains a need for a method to quickly and cheaply develop MPC strategies during early phase development for biomanufacturing processes
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Brandon Downey, John Schmitt, and Jeffrey Breit, "A highly automated, continuous method for developing active controllers of product quality attributes in early phase clinical development" in "Cell Culture Engineering XVI", A. Robinson, PhD, Tulane University R. Venkat, PhD, MedImmune E. Schaefer, ScD, J&J Janssen Eds, ECI Symposium Series, (2018). http://dc.engconfintl.org/ccexvi/124