1. History and mission
Biopharmaceuticals such as mammalian cell-based recombinant protein pharmaceuticals are the most rapidly growing product segment in modern life sciences. The availability of high productivity cell lines providing up to double-digit gram level per liter has resulted in production facilities shrinking in size. This, combined with the requirements of healthcare for more economic production processes and an increasing number of potential product candidates, has contributed to stainless steel being replaced by single-use equipment over the last 20 years. This concerns equipment used in upstream processing (e.g., mixers, bioreactors, filters, pumps), downstream processing (e.g., centrifuges, membrane adsorbers) and filling (e.g., needles, storage vessels). In fact, first complete single-use production facilities such as those of WuXi AppTec in Shanghai are running. Further facilities in Asia, America and Europe came into operation and are under construction. Latest trends focus on process intensification and continuous productions using single-use systems and applications beyond biopharmaceutical industry (chemical industry, cosmetics and foodstuff industry).
In 2011, our platform was founded by the biotechnet. The mission is to support the implementation of single-use devices and corresponding technologies in processes aimed at biotherapeutics and beyond in Switzerland. We will expand single-use applications and want to increase our global network activities in research and training.
2. Platform members
The platform is lead by Prof. Regine Eibl and has both industrial and academic research partners in Europe and the USA. It is closely co-operating with the DECHEMA working group „Single-use technology in biopharmaceutical manufacturing“. Common activities with the DECHEMA group have already resulted in common publications (see www.dechema.com).
Our platform has currently no paying members. To become a member, please contact Prof. Dr. Regine Eibl for details. The partnership fee is CHF 500.- per year.
3. Events and News
Together with the DECHEMA we are currently writing a white paper about continuous single-use bioprocessing and its challenges.
3.2 Upcoming events
7th advanced training course : Cell expansion and protein expression: An introduction for standard and single-use bioreactors
The annual course will take place from 19th August - 6th September 2019. It will provide students the opportunity of an international exchange and knowledge transfer in an unique atmosphere. Among 25 lectures covering the state of the art in cell cultivation techniques, 16 different exercises will be executed to deepen the theoretical background. Furthermore, the participants will meet experts from the biotech industry to debate about latest trends and for more discussions outside the university building an exciting social programme is planned. Please contact Dipl. Ing. Sören Werner for more detailed information (email: firstname.lastname@example.org).
In 2019, Biotech 2019 will take place on 2th and 3th of July in Wädenswil. The conference entitled „Biopharmaceutical manufacturing and single-use technologies“ will focus on the possibilities of process intensification and continuous bioprocessing using single-use technologies. Organizers are the Institute of Chemistry and Biotechnology of the Zurich University of Applied Sciences, the biotechnet Switzerland, the NTN Swissw Biotech and the DECHEMA. In addition to oral presentations, an exhibition of industrial equipment and a poster event are planned. On 4th of July, a post-conference discussing the potential of single-use systems for cellular agriculture applications (e.g. plant cell culture based cosmetics and food supplement ingredients, clean meat) follows. The internet page www.biotech2019.ch is under construction.
3.3 Past events
We presented our research activities at the following international conferences last and this year:
- ECI conference „Single-Use Technologies III: Scientific and Technological Advancements“, Salt Lake City, 09/2018
- Bioprocessing Days, Recklinghausen, 02/2018
- ECA Conference, Vienna, 10/2017
- Sino-German Symposium, Berlin, 09/2017
- Continuous Biomanufacturing Conference, Oxford, 06/2017
- ESACT, Lausanne, 05/2017
The majority of our projects is directly financed by companies (suppliers and appliers). Platform members are also involved in different Inosuisse- and Eurostar projects.
5. Read more
Research articles presenting results from platform projects
V. Jossen, R. Eibl, C. van den Bos, D. Eibl (2018) Manufacturing human mesenchymal stem cells at clinical scale: Process and regulatory challenges. Applied Microbiology and Biotechnology, doi.org/10.1007/s00253-018-8912-x
R. Eibl, V. Jossen, D. Eibl (2018) Therapeutische Antikörper: Einweg-Bioreaktoren. Chemie in unserer Zeit, DOI:10.1002jciuz.201800803
D. Eibl, R. Eibl (2017) Flexible biomanufacturing for the production of biotherapeutics. Pharmaceutical Biomanufacturing 5(1), 001-002
C. Schirmer, K. Blaschczok, U. Husemann, M. Leupold, C. Zahnow, J. Rupprecht, R. Glöckler, G. Greller, R. Pörtner, R. Eibl, D. Eibl (2017) Standardized qualification of stirred reactors for microbial biopharmaceutical production processes. Chemie Ingenieur Technik, DOI:10.1002/cite.201700039
R. Eibl, D. Eibl (2017) Single-Use-Systeme in der biopharmazeutischen Produktion: Chancen und Herausforderungen. Pharmaceutical Industry 79, 719-724
S.C. Kaiser, S. Werner, V. Jossen, M. Kraume, D. Eibl (2016). Development of a method for reliable power input measurements in conventional and single-use stirred bioreactors at laboratory scale. Engineering in Life Sciences, DOI:10.1002/elsc.201600096
A. Khojasteh, M.Hossein Mirjalili, J. Palazon, R. Eibl, R. M. Cusido (2016) Methyl jasmonate enhanced production of rosmarinic acid in cell cultures of Satureja khuzistanica in a bioreactor. Engineering in Life Sciences. DOI:10.1002/elsc.201600064
C. Demuth, J. Varonier, V. Jossen, R. Eibl, D. Eibl (2016) Novel probes for pH and dissolved oxygen measurements from millilitre to benchtop scale. Applied Microbiology and Biotechnology, DOI : 10.1007/s00253-016-7412-0
- V. Jossen, C. Schirmer, D.M. Mostafa Sindi, R. Eibl, M. Kraume, R. Pörtner, D. Eibl (2016) Theoretical and practical issues that are relevant when scaling up hMSC microvcarrier production processes. Stem Cells International, Article ID 4760414, htpp://dx.doi.org/10.1155/2016/47604014
- T. Fries, I. Dittler, K. Blaschczok, C. Löffelholz, W. Dornfeld, R. Schöb, A. Drews, D. Eibl (2015) Quantifizierung der hydromechanischen Beanspruchung von Pumpen auf tierische Zellen mittels des nicht-biologischen Modellsystems Emulsion. Chemie Ingenieur Technik. DOI:10.1002/cite.201500126
- I. Dittler, W. Dornfeld, R. Schöb, J. Cocke, J. Rojahn, M. Kraume, D. Eibl (2015) A cost effective and reliable method to predict mechanical stress in single-use and standard pumps. J. Vis. Exp., DOI:10.3791/53052.
- 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
- C. Schirmaier, V. Jossen, S.C. Kaiser, F. Jüngerkes, S. Brill, A. Safavi-Nab. A. Siehoff, C. van den Bos, D. Eibl, R. Eibl (2014) Scale-up of adipose tissue-derived mesenchymal stem cell production in stirred single-use bioreactors under low-serum conditions, Engineering in Life Sciences, 14(3): 292-303, DOI: 10.1002/elsc.201300134
- 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
- K. Blaschczok, S.C. Kaiser, C. Löffelholz, N. Imseng, J. Burkart, P. Bösch, W. Dornfeld, R. Eibl, D. Eibl (2013) Investigations on Mechanical Stress Caused to CHO Suspension Cells by Standard and Single-Use Pumps, Chemie Ingenieur Technik 85 (1-2), 144 – 152, DOI: 10.1002/cite.201200135
- S.C. Kaiser, V. Jossen, C. Schirmaier, D. Eibl, S. Brill, C. van den Bos, R. Eibl (2013) Fluid Flow and Cell Proliferation of Mesenchymal Adipose-Derived Stem Cells in Small-Scale, Stirred, Single-Use Bioreactors, Chemie Ingenieur Technik 85 (1-2), 95 – 102, DOI: 10.1002/cite.201200180
Book chapters presenting results from platform projects
- C. Schirmer, T. Nussbaumer, R. Schöb, R. Pörtner, R. Eibl, D. Eibl (2018) Development, engineering and biological characterization of stirred tank bioreactors. In: Yen M-K, Chen Y-C (eds.), Biopharmaceuticals. IntechOpen. DOI:10.5772/intechopen.79444
- T. Anderlei, D. Eibl, R. Eibl, D. Eisenkrätzer, G. John, W. Hohenauer, V. Jossen, H. Niederkrüger, T. Peuker, R. Pörtner, M. Tanner, K. Tiemann, J. Wagner (2017) Facility of the Future. DECHEMA, ISBN: 978-3-89746-199-4
- B. Badertscher, R. Eibl, D. Eibl (2017) Single-Use-Technologies from A-Z. DECHEMA. http://a-z-singleuse.org/
- S. Werner, R. W. Maschke, D. Eibl, R. Eibl (2017) Bioreactor technology for sustainable production of plant cell-derived products. In: Pavlov A, Bley, T (eds.), Bioprocessing of plant in vitro systems, 1-20, Springer. ISBN: 978-3-319-32004-5, DOI: 10.1007/978-3-319-32004-5_6-1
- V. Jossen, R. Eibl, R. Pörtner, M. Kraume, D. Eibl (2016) Stirred bioreactors: Current state and developments, with special emphasis on biopharmaceutical production processes. In: Larroche C, Sanroman MA, Du G, Pandey A (eds.), Bioprocesses, bioreactors and controls. Part 2: Bioreactors for industrial processes, 179-216, Elsevier, ISBN: 9780444636638
- W. Meusel, C. Löffelholz, U. Husemann, T. Dreher, G. Greller, J. Kauling, D. Eibl, S. Kleebank, I. Bauer, R. Glöckler, P. Huber, W. Kuhlmann, G.T. John, S. Werner, S.C. Kaiser, R. Pörtner, M. Kraume (2016) Recommendations for process engineering characterization of single-use bioreactors and mixing systems by using experimental methods. DECHEMA, ISBN: 978-3-89746-171-0
- S. C. Kaiser, D. Eibl, R. Eibl (2015) Single-use bioreactors for animal and human cells. In: Al-Rubeai M (ed.), Animal cell culture. Cell Engineering 9, 445-499, Springer Cham: DOI: 10.1007/978-3-319-10320-4
- 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
- R. Eibl, C. Löffelholz, D. Eibl (2014) Disposable bioreactors for inoculum production and protein expression. In: Pörtner R (ed.), Animal cell biotechnology: Methods and protocols, methods in molecular biology. Vol. 1104, 265-284, Humana Press. DOI: 10.1007/978-1-62703-733-4_18
- C. Ries, C. John, R. Eibl (2011) A new scale-down approach for the rapid development of Sf21/BEVS-based processes - a case study, In: Single-use technology in biopharmaceutical manufacture, R. Eibl, D. Eibl (eds), John Wiley & Sons, Hoboken, New Jersey, 208-213, (ISBN 978-0-470-43351-5), DOI: http://dx.doi.org/10.1002/9780470909997.ch17