During the past decade, the productivity of fed-batch mammalian cell culture systems has increased significantly. Driven by optimised strains and improved culture media, biomass concentrations have increased from 1–3g/L to 7–10g/L, particularly for monoclonal antibody (mAb) production, which facilitates the use of smaller-scale production vessels.1,2
Higher, more concentrated yields often challenge the capacities of depth filters. For volumes greater than 500 L, the use of a centrifuge has become essential to reduce both costs and waste during processing. However, the introduction of a ready-to-use clarification system that enables single-use processing at volumes of up to 2,000 L may provide a commercially viable solution and replace both centrifuges and depth filters in a single step.
High product titres derived from increased cell densities, as opposed to increased specific productivities per cell, result in a considerable solid mass that challenges commonly used harvesting techniques. And, although single-use harvesting technologies are available, frequently used depth filters tend to become blocked at lower loading capacities when processing highly concentrated biomasses. Higher contaminant concentrations also make depth filters more sensitive to batch variation. Single-use cell removal solutions such as centrifugation are available, but lack capacity.