October 18-21, 2015
The single-use bioreactor market was estimated to have grown at a CAGR of 20% in 2014. Wave-mixed bioreactors and stirred bioreactors represent the largest segment of today`s single-use bioreactor market, and are preferred by process developers and manufacturers of preclinical and clinical samples when high-value products up to medium scale and products requiring high safety demands are in focus. However, wave-mixed and stirred single-use bioreactors are also becoming increasingly important for commercial biopharmaceutical productions. This is ascribed to the availability of high-productivity cell lines, which require smaller bioreactors. In addition, the availability of bioengineering data and cultivation bags with improved films enables optimized operations with wave-mixed and stirred single-use bioreactors, whereby the risks of leachable migration and adsorption of hydrophobic components are reduced.
Based on a brief description of the current single-use bioreactor market, we aim to highlight the predominance of wave-mixed and stirred versions, and their main applications. In addition, their advantages and limitations are summarized. An insight into our long-term work with wave-mixed and stirred single-use bioreactors is given in the main part of our presentation, and results from cultivations with different expression systems covering plant cells, insect cells and mesenchymal stem cells (1-4) are provided. In this context, the advantageous combination of bioengineering and cell biological expertise is demonstrated for both process development and scale-up.
(1) N. Lehmann, I. Dittler, M. Lämse, A. Ritala, H. Rischer, D. Eibl, K.M. Oksman-Caldentey, R. Eibl (2014) Disposable bioreactors for the cultivation of plant cell cultures. In: Paek KY, Murthy HN, Zhong JJ (eds.), Production of biomass and bioactive compounds using bioreactor technology, 17-46, Springer Berlin. DOI: 10.1007/978-94-017-9223-3_2. (2) R. Eibl, N. Steiger, S. Wellnitz, T. Vicente, C. John and D. Eibl (2014) Fast Single-Use VLP Vaccine Productions Based on Insect Cells and the Baculovirus Expression Vector System: Influenza as Case Study, Advances in Biochemical Engineering/Biotechnology 138, 99-125, DOI: 10.1007/10_2013-186 (3) V. Jossen, R. Pörtner, S. Kaiser; M. Kraume, D. Eibl, R. Eibl (2014) Mass production of mesenchymal stem cells – Impact of bioreactor design and flow conditions on proliferation and differentiation. In: Eberli D (ed.), Regenerative Medicine and Tissue Engineering, InTech. ISBN 978-953-51-4114-3 (4) V. Jossen, S. C. Kaiser, C. Schirmaier, J. Herrmann, A. Tappe, D. Eibl, A. Siehoff, C. van den Bos, R. Eibl (2014) Modification and qualification of a stirred single-use bioreactor for the improved expansion of human mesenchymal stem cells at benchtop scale, Pharmaceutical Bioprocessing, 2 (4):311-322