Over the last few years, we have discussed various design approaches and compliance trends. In this article, we will tackle a design problem that typically emerges in a mature production organization. Most biotechnology organizations have designed their monoclonal antibody (mAb) production operations to handle 1 to 4 g/L titers. The typical design features a cluster of large-scale (≥10,000 L) batch bioreactors or multiple trains of 1,000-liter reactors. The bioreactor turnover is generally such that a harvest happens every few days, and, when sequenced properly, a single downstream purification train can handle the output of the several bioreactors. In the world of perfusion, the downstream columns are small and dedicated to the perfusion “train.”
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