Monday, July 30, 2007
P54

Disposable Perfusion Bioreactor System: Production of Therapeutic Proteins Using Disposable Stirred Tank and Disposable Centrifugation Cell Retention Device

Jin Yin1, Gan Wei1, Yas Saotome1, and Geoffrey Hodge2. (1) Shire Human Genetic Therapies, 700 Main Street, Cambridge, MA 02139, (2) Xcellerex Inc., 170 Locke Drive, Marlborough, MA 01752

A fully disposable perfusion stirred tank bioreactor system has been developed for the production of therapeutic proteins. The system consists of a disposable stirred tank bioreactor (Xcellerex XDR™) and a disposable centrifugation cell retention device (Pneumatic Scale CentriTech®).  A 200 L scale system was evaluated using a human cell line generated for the production of a therapeutic protein. This evaluation run was conducted for 28 days, with a continuous perfusion rate of one bioreactor working volume per day utilizing a culture medium free of animal-derived components. The culture reached a density of 10 million viable cells per mL while cell viability remained higher than 88% throughout the process.  Data obtained with the 200 L disposable bioreactor run will be discussed, in comparison to those of non-disposable bioreactor runs.