ABSTRACT
New technologies in downstream process devices are enabling the bioprocessing industry
to cope with new standards established by upstream manufacturing. About 10 years ago
monoclonal antibody production titers were at 0.2-0.5 g/L. Current production titers are
at 1 g/L and in the not too distant future these titers may reach 5-10 g/L (Wurm, 2004).
These higher upstream yields will put pressure on downstream process unit operations, in
particular chromatography columns. Columns used for large scale processing are already
quite large. Greater product amounts will lead to even larger columns or batch cycling.
Both of which are not appealing and for different reasons. Investment in larger columns
and skids will have a negative impact on cost of goods. Cycling may prove to be a more
economical solution with regard to capital and consumable expenditures. However, this
will lead to increased validation efforts that will also have an economic imprint. Both of
these solutions are cumbersome attempts to solve a real and impending problem. In recent
years membrane chromatography has demonstrated it can offer a real solution to these
forecasted bioprocessing bottlenecks. Current throughputs with membrane devices are
dramatically greater than conventional columns on a gram per liter basis and are steadily
improving. As will be discussed later, this is actually reducing the volume of sorbent
required for certain chromatography unit operations. Thus, positively effecting overall
process economy.
