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.”

To read more go to https://www.bioprocessonline.com/doc/renovating-an-existing-biotech-plant-to-accommodate-a-higher-titer-product-0001