456526 Accelerating Manufacturing in a Clinical Drug Substance Plant through Application of Plant Simulation

Thursday, November 17, 2016: 1:42 PM
Continental 5 (Hilton San Francisco Union Square)
John Robinson, Modeling and Simulation, KBI Biopharma, Boulder, CO

Given the major investment required to build or expand biopharmaceutical manufacturing facilities, intensification of existing assets is a highly valuable proposition. However, drug substance processes have many complex operational constraints. Increasing the run rate of a facility should only be undertaken when a thorough evaluation of all operational constraints has been performed.

In this case study, plant simulation was applied to an existing clinical drug substance manufacturing facility executing a wide variety of processes to evaluate opportunities to increase facility run rate. The modeling effort identified an opportunity to increase capacity by 40% with minimal capital investment. At current time, with partial implementation of the identified changes, a 20% increase in run rate has been realized.

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