Tuesday, November 10, 2009 - 1:00 PM
S26

Disposable orbital shake bioreactor system from ml to 1000 Liter for cell culture - from concept to reality

Florian M. Wurm, Faculty of Life Sciences - IBI LBTC, EPFL Swiss Federal Institute of Technology Lausanne, CH J2 506 (Building CH) Station 6, Lausanne, 1015, Switzerland, Maria De Jesus, ExcellGene SA, Rte de l'Ile au Bois 1A, Monthey, 1870, Switzerland, and Markus Kühner, Kuhner AG, Birsfelden CH 4127, Switzerland.

Orbitally shaken small scale vessels (TubeSpin®-reactors) were developed in the years 2000-2002 with the hope to replace spinners and small scale (0.5-2 L) instrumented bioreactors for suspension cultures of animal cells. TubeSpin® reactors, in combination with controlled incubator shakers have now become a well accepted scale-down system for cell culture process and medium development. The excellent performance of these 5-30 ml cultures stimulated work towards larger orbitally shaking systems. Experience has been published from the lab of the co-authors on both cylindrical and "square-shaped" bottles (glass and plastic) of various size. The obtained cell culture performance was very found to be excellent. Recently, both a 200 Liter and a 2000 Liter nominal volume bioreactor has been developed by Kuhner AG in collaboration with the coauthors as prototypes and have been used in conjunction with disposable, presterilized bags from Sartorius-Stedim AG in Germany. Critical engineering data over a wide range of conditions and as well as case studies of individual cell culture production runs will be presented in this paper. Overall, the data support the notion that orbital shaking may be an excellent alternative to stirring for cell culture applications, showing low shear stress, high gas transfer rates and efficient mixing, contributing to excellent biological performance of cultures for production of recombinant proteins.