P147: Growth Performance Variability of Mammalian Cell Cultures Using Polyethylene Based Disposable Technology

Biogen Idec is evaluating disposable biomanufacturing technology to create added flexibility.  Considerable development work has been focused towards the implementation of disposable bioreactor systems as an alternative to industry standard stainless steel systems.  Mammalian cell culture passages have been performed in multiple disposable platforms, including stirred-tank and rocker systems.  In both types of systems, questionable (slow) growth characteristics in expansion cell culture passages have been observed, with no apparent root cause.  Experiments were designed and executed to determine how various operational parameters (agitation rate, working volume, pH control) affected cell culture performance.  Multiple lots of disposable bioprocessing vessels with polyethylene (PE) contact layers were also incorporated into these experiments.  Experimental data and results suggesting that lot variability of disposable technology can have a significant effect on cell culture process performance will be presented.