Biological performance of two different 1000 L single‐use bioreactors applying a simple transfer approach

Process transfer is associated with a considerable risk potential. The most critical equipment aspects in upstream operations are the type and scale of bioreactors. Single‐use systems have the advantage of a relatively fixed bioreactor design where only few adaptations can be made, e.g. in stirrer geometry or type of submerse aeration. Here, we describe the transfer of a Chinese hamster ovary fed‐batch process in the 1000 L scale from a XDR ™ to a Thermo Scientific Hyclone Single‐Use Bioreactor ( S.U.B. ) used for GMP compliant manufacturing of biologics. The transfer method, which was based on a preceding intensive characterization of both bioreactors, aimed either to keep the oxygen mass transfer or the power input constant. The transfer strategies were evaluated theoretically based on derived empirical correlations for the mass transfer coefficients, k L a O2 and k L a CO2 . An operation boundary of 10–31 W m −3 for the S.U.B. bioreactor was defined, which is an approximately 35 % higher power input compared to that in the XDR™. The transfer strategy succeeded in maintaining essential biological parameters such as cell concentration (±5%), viability (±2%), and product formation (±3%) very similar. This is, to the authors’ knowledge, the first time that distinct process performance comparison in different 1000 L SUB s is published.