Scale-Up of a PER.C6~R Fed-Batch Process in 50 and 250 L Hyclone Single Use Bioreactors Compared to 50 and 250 L Stainless Steel Bioreactors

摘要

The Hyclone Single Use Bioreactors (SUBs) are a new type of disposable bioreactors that mimic classical stainless steel stirred tank bioreactors, but at a fraction of the costs. We find the systems to be of particular use for our multipurpose cGMP facility. With minimal or no modifications we can hook-up 250 L SUBs to our existing roll-on roll-off controllers for autoclavable 50-100 L bioreactors, thereby increasing DSMs clinical production capacity considerably without significant investments in utilities or the facility. Additional up-sides are the elimination of product carry-over risk, and the reduced changeover time and costs.In this study for the first time the growth and performance of an antibody producing PER.C6~R clone has been evaluated in SUBs at 50 and 250 L scale. The results have been compared with bench scale bioreactors and 50 and 250 L stainless steel bioreactors.