Tag: <span>facility design</span>

A basic engineering study has been performed to evaluate three different strategies for the production of monoclonal antibodies (MAbs) from Chinese hamster ovary (CHO) cells. Cells are expanded in suspension culture and are then inoculated into either fed batch or perfusion culture for MAb production. The first strategy, which is also the current industry standard, uses fed batch culture with the cells in suspension in a stirred tank fermenter. The second strategy uses perfusion culture with the cells immobilized on Cytopore™ microcarriers in a stirred tank fermenter. The third and final strategy is perfusion culture with Cytoline™ microcarriers in a fluidized bed fermenter. Perfusion cultures, while leading to a somewhat lower product titer, were characterized by a much smaller equipment footprint. This in turn led to a >30% reduction in investment costs and a 12% reduction in MAb production costs calculated over five years of depreciation and ten years of production time…

Building a MAb bioprocessing plant is a process which normally takes three years. Before starting the engineering work, a “locked” process is ­necessary. This means that all the steps have to be defined by volume, time, material balances and product yield. These calculations are based on the results obtained during process development. The titer and yield of functional, recoverable product determines the plant size. Optimal volumetric ­productivity [g/(liter reactor volume * day)] is of utmost importance. The main difference between fed batch and perfusion culture is that in the fed batch, a centrifuge is required for cell removal, whereas in perfusion culture, cell removal is performed by dead end filtration. This is possible because the majority of the cells are immobilised on the microcarriers, thus minimizing the burden on the clarification unit…