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 14 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 are currently under construction.
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 in Switzerland. We will expand single-use applications and include the field of cell therapeutics. In addition, we 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 and the NTN Swiss Biotech, we edited the mini-encyclopedia „Single-use technology from A-Z“. The encyclopedia explains important and often used terms around the single-use topic. It is aimed to students of biotechnology and related disciplines, but also new comers from industry. The german version can be downloaded from: htpp://a-z-singleuse.org. The english version will be available in May 2016.
3.2 Upcoming events
Mammalian cell-based protein expression: From cell to bioactive substance (Part upstream processing)
This course will take place in March, 14th-18th. There are no free places available.
4th advanced training course : Cell expansion and protein expression: An introduction for standard and single-use bioreactors
The annual course will take place from 9th-26th August 2016. 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: email@example.com).
In this year, Biotech 2016 will take place on 5th and 6th of September in Wädenswil. The conference entitled „Biopharmaceutical manufacturing and single-use technologies“ will focus on the development and manufacture of biosimilars, cell therapeutics as well as microbial products and single-use production facilities. 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 7th of September, a post-conference discussing new training concepts for flexible biopharmaceutical productions with single-use systems follows. Details and contact persons can be found on the internet page www.biotech2016.ch.
3.3 Past events
We presented our research activities at the following conferences last year:
- ECI conference „Scale up and manufacturing of cell-based therapies“, San Diego, 01/2015
- Biopharmaceutical Development & Production (BDP), Los Angeles, 03/2015
- A3P Bioproduction International Congress, Lausanne, 05/2015
- ESACT, Barcelona, 06/2015
- BioProcess International Conference & Exhibition, Boston, 10/2015
- ECI conference „Bridging polymer science to biotechnology applications“, Leesburg VA, 10/2015
- 8th conference on single-use disposables, Heidelberg, 11/2015
There is currently one platform project: Intelligent SCADA expert system for user friendly process control. The project is running from 08/2014-07/2017. Main implementtaion partner is the Infors.
5. Read more
Articles about training which appeared in Chimia and Chemie Plus
- Single-use technology: How to overcome existing limits. Chimia 2013, 67(9): 669-670
- Roche investiert in massgeschneiderte Ausbildung. ChemiePlus 2015, 6/7: 32-35
- One step ahead in cell cultivation – International Advanced Training Course at ZHAW Wädenswil. Chimia 2015, 69 (10): 631-633
Research articles presenting results from platform projects
- 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
- 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