Volume 5 Supplement 8
Single use bioreactors for the clinical production of monoclonal antibodies – a study to analyze the performance of a CHO cell line and the quality of the produced monoclonal antibody
© Sonja et al; licensee BioMed Central Ltd. 2011
Published: 22 November 2011
In recent years, the use of disposables in the pharmaceutical industry has increased extensively. Disposables can be used in many areas of biopharmaceutical production. The use of disposables not only reduces investment costs, but also requires less manpower to operate, since time consuming change-over procedures are significantly reduced. In addition, disposables enable a high flexibility by reducing unit operation times such as cleaning and sterilization as well as the validation of these procedures . Disposable bioreactors can be subdivided into two main groups, static and dynamic systems. The dynamic systems differ with regard to the power input in stirred, vibromixed or wave-induced systems . Since the power input, the mixing time, the tip speed and the oxygen transfer coefficient may influence the cell culture process and the product quality itself, a thorough characterization of the system used is necessary . SSB (stainless steel bioreactors) and SUB (single use bioreactors) differ in terms of their physical design. Usually, an SSB is equipped with two or three stirrer blades. In contrast, stirred SUBs usually have just one stirrer blade. In addition, the design and the position of the stirrer differ significantly. These distinctions lead to different physical characteristics regarding the power input, mixing time, and tip speed. The SUBs are characterized by a significantly lower power input and tip speed and a significantly higher mixing time. In order to maintain a sufficient oxygen transfer coefficient, the single use bioreactor is equipped with a micro sparger with a pore size of 25 µm. Furthermore, pure oxygen can be used to achieve higher dissolved oxygen concentrations in the cell cultivation medium. This study describes the influence of these technical differences on the performance of a CHO cell line and the product quality of a monoclonal antibody.
99.7 ± 0
0.267 ± 0.047
0.1 ± 0
99.7 ± 0
0.3 ± 0
0.1 ± 0
The present study describes the influence of a single use bioreactor on the performance of a production CHO cell line, on the product quality of the produced antibody and the process related impurities in comparison to a commercial stainless steel bioreactor. It seems that the microsparger of the SUB lead to a cell damage, which is measured by LDH activity. Nevertheless, our findings indicate that this cell damage has no influence on the productivity, the concentration of DNA and HCP and, most importantly on the quality of the antibody.
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This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.