(692e) Accelerating Manufacturing in a Clinical Drug Substance Plant through Application of Plant Simulation

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.