Monday, July 30, 2007
P24

Introduction of disposable bioreactors into a large-scale GMP manufacturing campaign

Douglas H. Osborne, Helena Yusuf-Makagiansar, and Ching Lee. Cell Culture Development, Biogen Idec, 5200 Research Place, San Diego, CA 92122

The introduction of disposable bioreactors into a large-scale GMP manufacturing campaign presented several challenges.  Process robustness, facility fit, and vendor related items were addressed with introduction of disposable bioreactors into manufacturing. While hurdles were experienced, disposable bioreactors streamlined operations and generated robust data.